Chronic Lymphocytic Leukemia
Conditions
Brief summary
The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B).
Interventions
DRUGBendamustine
Bendamustine will be administered at a dose of 70 mg/m\^2 via IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
DRUGVenetoclax
Venetoclax will be administered at an initial dose of 20 mg via tablet orally QD, incremented weekly up to a maximum dose of 400 mg during a 5-week ramp-up period. Venetoclax will be continued at 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to disease progression (PD) or 2 years, whichever occurs first. R/C Substudy: venetoclax will be administered for 5-week dose ramp-up period to reach the target dose of 400 mg QD. Venetoclax will continue to be administered during the rituximab cycles until disease progression or for a maximum of 2 years from Cycle 1R/C Day 1 of the R/C Substudy.
DRUGRituximab
Rituximab will be administered at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6. R/C Substudy: Following the venetoclax ramp-up period, rituximab will be administered for 6 cycles consisting of a single infusion on the first day of each 28-day cycle.
Sponsors
AbbVie
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of CLL per diagnostic criteria for relapsed or refractory CLL per the international workshop on chronic lymphocytic leukemia (iwCLL) guidelines * Previously treated with 1-3 lines of therapy (example: completed greater than or equal to \[\>/=\] 2 treatment cycles per therapy), including at least one standard chemotherapy-containing regimen * Participants previously treated with bendamustine only if their duration of response was \>/= 24 months * Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (\</=) 1 * Adequate bone marrow function * Adequate renal and hepatic function * Participants must use effective birth control throughout study until at least 30 days after study treatment or 1 year after rituximab treatment, whichever is later; female participants must not be pregnant or breast-feeding * For participants with the 17p deletion, previously treated with 1-3 lines of therapy, including at least one prior standard chemotherapy-containing regimen or at least one prior alemtuzumab-containing therapy Inclusion Criteria R/C Substudy: * Participants randomized to Arm A or Arm B with a confirmed disease progression of CLL per iwCLL criteria * Participants who have not received new anti-CLL therapy following disease progression in Arm A or Arm B * Adequate renal and hepatic function per laboratory reference range
Exclusion criteria
* Transformation of CLL to aggressive non-Hodgkin lymphoma or central nervous system (CNS) involvement by CLL * Undergone an allogenic stem cell transplant * A history of significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular or hepatic disease * Hepatitis B or C or known human immunodeficiency virus (HIV) positive * Receiving warfarin treatment * Received an anti-CLL monoclonal antibody within 8 weeks prior to the first dose of study drug * Received any anti-cancer or investigational therapy within 28 days prior to the first dose of study drug or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(ies) of any previous therapy * Received cytochrome P450 3A4 (CYP3A4) inhibitors (such as fluconazole, ketoconazole and clarithromycin) or inducers (such as rifampin, carbamazapine, phenytoin, St. John's Wort) within 7 days prior to the first dose of venetoclax * History of prior venetoclax treatment * Participants with another cancer, history of another cancer considered uncured on in complete remission for \<5 years, or currently under treatment for another suspected cancer except non-melanoma skin cancer or carcinoma in situ of the cervix that has been treated or excised and is considered resolved * Malabsorption syndrome or other condition that precludes enteral route of administration * Other clinically significant uncontrolled condition(s) including, but not limited to, systemic infection (viral, bacterial or fungal) * Vaccination with a live vaccine within 28 days prior to randomization * Consumed grapefruit or grapefruit products, seville oranges (including marmalade containing seville oranges), or star fruit within 3 days prior to the first dose of study treatment * A cardiovascular disability status of New York Heart Association Class \>/=3. Class 3 is defined as cardiac disease in which participants are comfortable at rest but have marked limitation of physical activity due to fatigue, palpitations, dyspnea, or anginal pain * Major surgery within 30 days prior to the first dose of study treatment * A participant who is pregnant or breastfeeding * Known allergy to both xanthine oxidase inhibitors and rasburicase
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines | Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months) | PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the investigator using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% confidence interval (CI) was computed using method of Brookmeyer and Crowley. |
| Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death | Baseline up to PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months) | Assessment of response was performed by the investigator according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (greater than \[\>\] 1.5 centimeters \[cm\]); unequivocal progression of non-target lesion; an increase of greater than or equal to (\>/=) 50 percent (%) compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000 per microliter (mcL), or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 grams per deciliter (g/dL) or to less than \[\<\] 10 g/dL. Percentages are rounded off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS as Assessed by the IRC Using Standard iwCLL Guidelines | Baseline up to PD or death, whichever occurred first (up to approximately 3 years) | PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. No new IRC data was generated post the primary analysis. |
| Percentage of Participants With PD or Death as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by Fluorescence In-situ Hybridization (FISH) Test | Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months) | Assessment of response was performed by the investigator according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; an increase of \>/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 g/dL or to \<10 g/dL. Percentages are rounded off. |
| PFS as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test | Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months) | PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the investigator using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. |
| Percentage of Participants With PD or Death as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test | Baseline up to PD or death, whichever occurred first (up to approximately 3 years) | Assessment of response was performed by the IRC according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; an increase of \>/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 g/dL or to \<10 g/dL. No new IRC data was generated post the primary analysis. |
| PFS as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test | Baseline up to PD or death, whichever occurred first (up to approximately 3 years) | PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. No new IRC data was generated post the primary analysis. |
| Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines | Baseline up to approximately 8 years 5 months | Response was assessed by investigator according to iwCLL guidelines and was confirmed by repeat assessment \>/=4 weeks after initial documentation. CR: peripheral blood lymphocytes \<4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with \<30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: \>/=50% reduction in two of following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and 1 of following: neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL or \>/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. 95% CI was computed using Pearson-Clopper method.Percentages are rounded off. |
| Percentage of Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the IRC Using iwCLL Guidelines | Baseline up to last FUV (up to approximately 3 years) | Response was assessed by IRC according to iwCLL guidelines and was confirmed by repeat assessment \>/=4 weeks after initial documentation. CR: peripheral blood lymphocytes \<4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, constitutional symptoms; neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with \<30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: \>/=50% reduction in 2 of following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; 1 of following: neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL or \>/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. 95% CI was computed using Pearson-Clopper method.No new IRC data was generated post primary analysis. |
| Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the Investigator Using iwCLL Guidelines | End of combination treatment response (EoCTR) visit (8 to 12 weeks after Cycle [C] 6 Day [1]); Cycle length = 28 days | Response was assessed by investigator according to iwCLL guidelines and was confirmed by repeat assessment \>/=4 weeks after initial documentation. CR: peripheral blood lymphocytes \<4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with \<30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: \>/=50% reduction in 2 of following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and 1 of following: neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL or \>/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. 95% CI was computed using Pearson-Clopper method. Percentages are rounded off. |
| Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the IRC Using iwCLL Guidelines | EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days | Response was assessed by the IRC according to the iwCLL guidelines and was confirmed by repeat assessment \>/=4 weeks after initial documentation. CR: peripheral blood lymphocytes \<4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with \<30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: \>/=50% reduction in two of the following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and one of the following: neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL or \>/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. The 95% CI was computed using Pearson-Clopper method. |
| Percentage of Participants Who Died | Baseline up to approximately 8 years 5 months | Percentage of participants who died from any cause, during the study, was reported. Percentage is rounded off. |
| Overall Survival (OS) | Baseline up to approximately 8 years 5 months | OS was defined as the time from the date of randomization to the date of death from any cause. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator. The median OS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. |
| Percentage of Participants With PD/Relapse, Start of a New Anti-Chronic Lymphocytic Leukemia (CLL) Therapy, or Death as Assessed by the Investigator Using iwCLL Guidelines | Baseline up to PD/relapse, start of a new anti-CLL therapy, or death from any cause, whichever occurred first (approximately 8 years 5 months) | Percentage of participants with PD/relapse, death from any cause, or start of a new non-protocol-specified anti-CLL therapy as assessed by the investigator, during the study, was reported. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; an increase of \>/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 g/dL or to \<10 g/dL. Percentages are rounded off. |
| Percentage of Participants With PD or Death Among Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the Investigator Using iwCLL Guidelines | From time of achieving best overall response until PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months) | Percentage of participants with PD as assessed by the investigator according to the iwCLL guidelines or death from any cause during the study was reported. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; an increase of \>/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 g/dL or to \<10 g/dL. CR, CRi, nPR, and PR have been defined in previous outcomes, and are not repeated here due to space constraint. Percentage is rounded off. |
| Plasma Venetoclax Concentrations | Pre-dose (0 hour, anytime before venetoclax administration) and 4 hours post-dose on D1 of Cycles 1 and 4; Cycle length = 28 days | — |
| Percentage of Participants With MRD Negativity in Bone Marrow | EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days | MRD-negativity was defined as the presence of \<1 malignant B-cell per 10000 normal B-cells in a sample of at least 200000 B-cells, as assessed flow cytometry technique. Percentage of participants with MRD-negativity was reported. The 95% CI was computed using Pearson-Clopper method. Percentages are rounded off. |
| Duration of Responses (DOR) as Assessed by the Investigator Using iwCLL Guidelines | From time of achieving best overall response until PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months) | DOR was defined as the time from first occurrence of a documented response of CR, CRi, nPR, or PR until PD/relapse, as assessed by the investigator according to the iwCLL guidelines, or death from any cause. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants without PD or death after response were censored at the last date of adequate response assessment. The median DOR was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. CR, CRi, nPR, and PR have been defined in previous outcomes, and are not repeated here due to space constraint. |
| Percentage of Participants With Start of New Anti-CLL Treatment or Death as Assessed by the Investigator | Baseline up to start of new ani-CLL therapy or death, whichever occurred first (up to approximately 8 years 5 months) | Percentage of participants with start of new non-protocol-specified anti-CLL therapy, as assessed by the investigator, or death from any cause, during the study, was reported. Percentage is rounded off. |
| Time to New Anti-CLL Treatment (TTNT) as Assessed by the Investigator | Baseline up to start of new ani-CLL therapy or death, whichever occurred first (up to approximately 8 years 5 months) | TTNT was defined as the time from randomization until start of new non-protocol-specified anti-CLL treatment or death from any cause. Participants without the event at the time of analysis were censored at the last visit date for this outcome measure analysis. The median TTNT was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. |
| Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood | EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days | MRD-negativity was defined as the presence of \<1 malignant B-cell per 10000 normal B-cells in a sample of at least 200000 B-cells, as assessed by the allele specific oligonucleotide polymerase chain reaction (ASO-PCR) and/or flow cytometry technique. Percentage of participants with MRD-negativity was reported. The 95% CI was computed using Pearson-Clopper method. Percentage is rounded off. |
| Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Baseline, Days 1, 8, and 15 of Cycles 1, 2, and 3; Cycle length = 28 days | MDASI is a 25-item validated questionnaire consisting of 2 parts. Part 1: 19-items divided into 2 scales, Core Symptom Severity (average of Questions 1 to 13; total 13 items: pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness) and Module Symptom Severity (average of Questions 14 to 19; total 6 items: night sweats, fevers and chills, lymph node swelling, diarrhea, bruising easy or bleeding, and constipation). Part 2: 6-items to assess Interference (symptom distress) (average of Questions 20 to 25; total 6 items: general activity, walking, work, mood, relations with other people, and enjoyment of life). Each item was rated from 0 to 10, with lower scores indicating better outcome. Total score for Core Symptom Severity, Module Symptom Severity, and Interference are reported which range from 0 to 10, with lower scores indicating better health-related quality of life (HRQoL). |
| Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days | EORTC QLQ-C30 is a validated self-report measure consisting of 30 questions incorporated into 5 functional scales (Physical, Role, Cognitive, Emotional, and Social), 3 symptom scales (fatigue, pain, nausea, and vomiting), a global health status/global QoL scale, and single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea). Most questions used 4-point scale (1='Not at all' to 4='Very much'), while 2 questions used 7-point scale (1='very poor' to 7='Excellent'). Scores were averaged, transformed to 0-100 scale; where higher score for functional scales=poor level of functioning; higher score for global health status/global QoL=better HRQoL. |
| Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days | The EORTC QLQ-CLL16 module is designed for participants with Stage 0 to Stage 4 CLL. It is composed of 16 questions and there are four multi-item scales on Fatigue (2 items), Treatment-related side effects (TRSE, 4 items), Disease-related symptoms (DRS, 4 items), and Infection (4 items); and two single-item scales on social activities and future health worries. Multi-item scales score are reported and the total score for each multi-item scale was transformed to result in a total score range of 0 to 100, where higher score = poor HRQoL. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From signing of informed consent form up to approximately 8 years 5 months | An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above. AEs were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE, v4.0) |
| Number of Participants With Grade 3 or Higher Tumor Lysis Syndrome (TLS) and Infusion-related Reactions (IRRs) | From signing of informed consent form up to approximately 8 years 5 months | An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A SAE is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above. TLS and IRRs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant; Grade 4 = Life-threatening; Grade 5 = Death. A higher grade indicates a worse outcome. |
| Event-Free Survival (EFS) as Assessed by the Investigator Using iwCLL Guidelines | Baseline up to PD/relapse, start of a new anti-CLL therapy, or death from any cause, whichever occurred first (approximately 8 years 5 months) | EFS was defined as the time from date of randomization until the date of PD/relapse, start of a new non-protocol-specified anti-CLL therapy, or death from any cause, whichever occurred first, as assessed by the investigator. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants without any of the specified event at the time of analysis were censored at the date of last adequate response assessment. In case of no post-baseline response assessment, participants were censored at the randomization date. The median EFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. |
| Percentage of Participants With PD or Death as Assessed by the Independent Review Committee (IRC) Using Standard iwCLL Guidelines | Baseline up to PD or death, whichever occurred first (up to approximately 3 years) | Assessment of response was performed by the IRC according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; an increase of \>/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 g/dL or to \<10 g/dL. No new IRC data was generated post the primary analysis. |
Other
| Measure | Time frame |
|---|---|
| Change From Baseline in Lymphocyte Subset Counts at Specified Time Points | Baseline, C4D14-28, Study Treatment Completion/Early Withdrawal (STC/EW, up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and at FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days |
Countries
Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Russia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
A total 389 participants took part in the study across 109 investigative sites in 20 countries i.e., Korea, Taiwan, Australia, New Zealand, Czech Republic, Hungary, Poland, Russia, Canada, United States of America, Austria, Belgium, Germany, Denmark, Spain, France, United Kingdom, Italy, Netherlands and Sweden from 17 March 2014 to 03 August 2022. The trial consisted of a main study and an optional Retreatment/Crossover (R/C) sub study.
Pre-assignment details
Of the 389 participants enrolled 7 participants in the bendamustine + rituximab (BR) arm did not receive a valid dose of study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Bendamustine + Rituximab Main Study Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6. | 195 |
| Venetoclax + Rituximab Main Study Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6. | 194 |
| Total | 389 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Main Study | Adverse Event | 0 | 1 | 0 | 0 |
| Main Study | Death | 83 | 52 | 0 | 0 |
| Main Study | Lost to Follow-up | 4 | 5 | 0 | 0 |
| Main Study | Physician Decision | 3 | 1 | 0 | 0 |
| Main Study | Randomized but not Dosed | 8 | 0 | 0 | 0 |
| Main Study | Reason not Specified | 0 | 6 | 0 | 0 |
| Main Study | Withdrawal by Subject | 26 | 11 | 0 | 0 |
| Re-Treatment/Crossover (R/C) Substudy | Death | 0 | 0 | 1 | 8 |
| Re-Treatment/Crossover (R/C) Substudy | Lost to Follow-up | 0 | 0 | 1 | 1 |
| Re-Treatment/Crossover (R/C) Substudy | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Bendamustine + Rituximab Main Study | Venetoclax + Rituximab Main Study |
|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 10.1 | 64.4 years STANDARD_DEVIATION 9.6 | 63.9 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 372 Participants | 186 Participants | 186 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) White | 359 Participants | 178 Participants | 181 Participants |
| Sex: Female, Male Female | 102 Participants | 44 Participants | 58 Participants |
| Sex: Female, Male Male | 287 Participants | 151 Participants | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 84 / 188 | 60 / 194 | 1 / 9 | 8 / 25 |
| other Total, other adverse events | 177 / 188 | 190 / 194 | 5 / 9 | 9 / 25 |
| serious Total, serious adverse events | 84 / 188 | 101 / 194 | 5 / 9 | 13 / 25 |
Outcome results
Primary
Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death
Assessment of response was performed by the investigator according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (greater than \[\>\] 1.5 centimeters \[cm\]); unequivocal progression of non-target lesion; an increase of greater than or equal to (\>/=) 50 percent (%) compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000 per microliter (mcL), or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 grams per deciliter (g/dL) or to less than \[\<\] 10 g/dL. Percentages are rounded off.
Time frame: Baseline up to PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death | 88.7 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death | 70.1 percentage of participants |
Primary
Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines
PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the investigator using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% confidence interval (CI) was computed using method of Brookmeyer and Crowley.
Time frame: Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines | 17.0 months |
| Venetoclax + Rituximab Main Study | Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines | 54.7 months |
Comparison: Stratified analysis: 17p deletion, risk status, geographic region.p-value: <0.000195% CI: [0.18, 0.29]Log Rank
Comparison: Unstratified Analysisp-value: <0.000195% CI: [0.19, 0.31]Log Rank
Secondary
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score
EORTC QLQ-C30 is a validated self-report measure consisting of 30 questions incorporated into 5 functional scales (Physical, Role, Cognitive, Emotional, and Social), 3 symptom scales (fatigue, pain, nausea, and vomiting), a global health status/global QoL scale, and single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea). Most questions used 4-point scale (1='Not at all' to 4='Very much'), while 2 questions used 7-point scale (1='very poor' to 7='Excellent'). Scores were averaged, transformed to 0-100 scale; where higher score for functional scales=poor level of functioning; higher score for global health status/global QoL=better HRQoL.
Time frame: Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days
Population: Patient reported outcome (PRO) evaluable population included all participants with baseline and at least one post-baseline PRO assessment. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV4; Social functioning | 1.97 units on a scale | Standard Deviation 27.35 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C2D1; Cognitive functioning | -0.19 units on a scale | Standard Deviation 15.34 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV5; Social functioning | 1.79 units on a scale | Standard Deviation 26.72 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C6D1; Emotional functioning | 2.06 units on a scale | Standard Deviation 18.74 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV6; Social functioning | 1.52 units on a scale | Standard Deviation 29.27 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C3D1; Cognitive functioning | -0.32 units on a scale | Standard Deviation 16.34 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV7; Social functioning | -2.56 units on a scale | Standard Deviation 23.42 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV9; Role functioning | -16.67 units on a scale | Standard Deviation 23.57 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV8; Social functioning | -10.00 units on a scale | Standard Deviation 22.36 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C4D1; Cognitive functioning | -1.54 units on a scale | Standard Deviation 17.41 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV9; Social functioning | -25.00 units on a scale | Standard Deviation 35.36 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline; Global health status/QoL | 63.02 units on a scale | Standard Deviation 21.45 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at STC/EW; Emotional functioning | 2.43 units on a scale | Standard Deviation 20.61 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C1D1; Global health status/QoL | 0.0 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline; Physical functioning | 82.59 units on a scale | Standard Deviation 17.46 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C5D1; Cognitive functioning | -1.94 units on a scale | Standard Deviation 18.1 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C1D1; Physical functioning | 0.0 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline; Emotional functioning | 78.98 units on a scale | Standard Deviation 22.47 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C2D1; Physical functioning | 0.31 units on a scale | Standard Deviation 15.81 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C6D1; Cognitive functioning | -2.68 units on a scale | Standard Deviation 16.97 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C3D1; Physical functioning | 0.22 units on a scale | Standard Deviation 16.43 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at EoCTR; Emotional functioning | 2.58 units on a scale | Standard Deviation 19.45 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C4D1; Physical functioning | 2.11 units on a scale | Standard Deviation 14.95 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at STC/EW; Cognitive functioning | -2.19 units on a scale | Standard Deviation 17.65 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C5D1; Physical functioning | 2.44 units on a scale | Standard Deviation 18.19 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV6; Role functioning | -4.04 units on a scale | Standard Deviation 27.01 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C6D1; Physical functioning | 2.25 units on a scale | Standard Deviation 16.82 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at EoCTR; Cognitive functioning | -2.23 units on a scale | Standard Deviation 18.11 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at STC/EW; Physical functioning | 1.68 units on a scale | Standard Deviation 18.76 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV1; Emotional functioning | 3.49 units on a scale | Standard Deviation 20.91 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at EoCTR; Physical functioning | 2.92 units on a scale | Standard Deviation 18.03 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV1; Cognitive functioning | -2.02 units on a scale | Standard Deviation 17.21 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV1; Physical functioning | 2.27 units on a scale | Standard Deviation 18.86 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C1D1; Emotional functioning | 0.0 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV2; Physical functioning | 2.40 units on a scale | Standard Deviation 19.21 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV2; Cognitive functioning | 1.32 units on a scale | Standard Deviation 16.16 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV3; Physical functioning | 2.54 units on a scale | Standard Deviation 17.83 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV2; Emotional functioning | 4.39 units on a scale | Standard Deviation 20.33 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV4; Physical functioning | 4.74 units on a scale | Standard Deviation 20.14 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV3; Cognitive functioning | -1.63 units on a scale | Standard Deviation 14.84 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV5; Physical functioning | 1.90 units on a scale | Standard Deviation 17.68 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV3; Role functioning | 5.26 units on a scale | Standard Deviation 31.16 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV6; Physical functioning | -1.41 units on a scale | Standard Deviation 15.34 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV4; Cognitive functioning | 0.44 units on a scale | Standard Deviation 17.63 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV7; Physical functioning | -3.08 units on a scale | Standard Deviation 11.74 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV3; Emotional functioning | 0.63 units on a scale | Standard Deviation 19.97 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV8; Physical functioning | -9.33 units on a scale | Standard Deviation 23.38 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV5; Cognitive functioning | -1.49 units on a scale | Standard Deviation 15.66 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV9; Physical functioning | -10.00 units on a scale | Standard Deviation 33 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline; Role functioning | 78.25 units on a scale | Standard Deviation 25.67 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C2D1; Emotional functioning | 2.24 units on a scale | Standard Deviation 20.07 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C1D1; Role functioning | 0.0 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV6; Cognitive functioning | -0.51 units on a scale | Standard Deviation 14.72 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C2D1; Role functioning | -1.26 units on a scale | Standard Deviation 27.45 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV4; Emotional functioning | 4.82 units on a scale | Standard Deviation 19.73 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C3D1; Role functioning | -0.10 units on a scale | Standard Deviation 29.64 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV7; Cognitive functioning | -1.28 units on a scale | Standard Deviation 14.37 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C4D1; Role functioning | 0.87 units on a scale | Standard Deviation 29.01 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV7; Role functioning | 2.56 units on a scale | Standard Deviation 29.54 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C5D1; Role functioning | 0.45 units on a scale | Standard Deviation 30.75 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV8; Cognitive functioning | 0.00 units on a scale | Standard Deviation 23.57 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C6D1; Role functioning | 0.70 units on a scale | Standard Deviation 29.92 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV5; Emotional functioning | 3.13 units on a scale | Standard Deviation 17.95 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at STC/EW; Role functioning | -0.41 units on a scale | Standard Deviation 32.91 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV9; Cognitive functioning | 16.67 units on a scale | Standard Deviation 23.57 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at EoCTR; Role functioning | 3.26 units on a scale | Standard Deviation 29.95 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline; Social functioning | 82.48 units on a scale | Standard Deviation 22.06 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV1; Role functioning | 2.93 units on a scale | Standard Deviation 32.31 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C3D1; Emotional functioning | 2.99 units on a scale | Standard Deviation 20.06 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C2D1; Global health status/QoL | 2.73 units on a scale | Standard Deviation 21.69 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C1D1; Social functioning | 0.0 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C3D1; Global health status/QoL | 2.34 units on a scale | Standard Deviation 24.66 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV6; Emotional functioning | 2.27 units on a scale | Standard Deviation 21.78 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C4D1; Global health status/QoL | 3.84 units on a scale | Standard Deviation 22.26 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C2D1; Social functioning | -2.44 units on a scale | Standard Deviation 21.44 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C5D1; Global health status/QoL | 7.36 units on a scale | Standard Deviation 24.2 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV5; Role functioning | 2.34 units on a scale | Standard Deviation 29.79 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C6D1; Global health status/QoL | 4.25 units on a scale | Standard Deviation 25 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C3D1; Social functioning | -2.32 units on a scale | Standard Deviation 22.61 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at STC/EW; Global health status/QoL | 4.32 units on a scale | Standard Deviation 26.2 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV7; Emotional functioning | 5.77 units on a scale | Standard Deviation 17.48 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at EoCTR; Global health status/QoL | 6.10 units on a scale | Standard Deviation 23.65 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C4D1; Social functioning | -0.55 units on a scale | Standard Deviation 22.15 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV1; Global health status/QoL | 5.91 units on a scale | Standard Deviation 24.57 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C4D1; Emotional functioning | 2.61 units on a scale | Standard Deviation 18.35 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV2; Global health status/QoL | 6.94 units on a scale | Standard Deviation 24.81 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C5D1; Social functioning | -5.48 units on a scale | Standard Deviation 26.49 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV3; Global health status/QoL | 4.80 units on a scale | Standard Deviation 25.3 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV8; Emotional functioning | 3.33 units on a scale | Standard Deviation 28.01 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV4; Global health status/QoL | 7.35 units on a scale | Standard Deviation 26.77 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C6D1; Social functioning | -5.13 units on a scale | Standard Deviation 24.8 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV5; Global health status/QoL | 4.46 units on a scale | Standard Deviation 23.89 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV8; Role functioning | 0.00 units on a scale | Standard Deviation 23.57 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV6; Global health status/QoL | 1.01 units on a scale | Standard Deviation 24 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at STC/EW; Social functioning | -4.06 units on a scale | Standard Deviation 27.71 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV7; Global health status/QoL | 8.33 units on a scale | Standard Deviation 25.69 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV9; Emotional functioning | -16.67 units on a scale | Standard Deviation 11.79 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV8; Global health status/QoL | 6.67 units on a scale | Standard Deviation 16.03 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at EoCTR; Social functioning | -0.47 units on a scale | Standard Deviation 24.95 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV9; Global health status/QoL | 0.00 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline; Cognitive functioning | 86.55 units on a scale | Standard Deviation 16.78 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV2; Role functioning | 3.07 units on a scale | Standard Deviation 32.63 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV1; Social functioning | -1.08 units on a scale | Standard Deviation 26.09 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C5D1; Emotional functioning | 1.14 units on a scale | Standard Deviation 18.79 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV2; Social functioning | 0.58 units on a scale | Standard Deviation 24.68 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C1D1; Cognitive functioning | 0.0 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV3; Social functioning | -0.91 units on a scale | Standard Deviation 24 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV4; Role functioning | 5.41 units on a scale | Standard Deviation 33.16 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C4D1; Physical functioning | 5.54 units on a scale | Standard Deviation 14.17 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV3; Role functioning | 1.88 units on a scale | Standard Deviation 28.17 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV4; Role functioning | -0.35 units on a scale | Standard Deviation 30.39 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV5; Role functioning | 1.75 units on a scale | Standard Deviation 34.2 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV6; Role functioning | -13.33 units on a scale | Standard Deviation 32.06 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV7; Role functioning | -16.67 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV8; Role functioning | 16.67 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline; Emotional functioning | 82.13 units on a scale | Standard Deviation 15.8 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C1D1; Emotional functioning | 4.35 units on a scale | Standard Deviation 15.17 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C2D1; Emotional functioning | 5.60 units on a scale | Standard Deviation 14.68 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C3D1; Emotional functioning | 5.34 units on a scale | Standard Deviation 19.09 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C4D1; Emotional functioning | 4.19 units on a scale | Standard Deviation 15.45 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C5D1; Emotional functioning | 3.97 units on a scale | Standard Deviation 17.37 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C6D1; Emotional functioning | 3.08 units on a scale | Standard Deviation 17.96 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at STC/EW; Emotional functioning | 5.34 units on a scale | Standard Deviation 18.69 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at EoCTR; Emotional functioning | 3.49 units on a scale | Standard Deviation 17.83 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV1; Emotional functioning | 4.37 units on a scale | Standard Deviation 18.5 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV2; Emotional functioning | 0.66 units on a scale | Standard Deviation 21.02 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV3; Emotional functioning | 2.82 units on a scale | Standard Deviation 17.66 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV4; Emotional functioning | 1.95 units on a scale | Standard Deviation 18.41 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV5; Emotional functioning | 2.63 units on a scale | Standard Deviation 20.61 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV6; Emotional functioning | 5.00 units on a scale | Standard Deviation 17.28 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV7; Emotional functioning | -8.33 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV8; Emotional functioning | 0.00 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline; Cognitive functioning | 89.86 units on a scale | Standard Deviation 14.91 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C1D1; Cognitive functioning | -1.24 units on a scale | Standard Deviation 14.01 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C2D1; Cognitive functioning | 0.25 units on a scale | Standard Deviation 14.06 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C3D1; Cognitive functioning | -1.56 units on a scale | Standard Deviation 17.5 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C4D1; Cognitive functioning | -0.26 units on a scale | Standard Deviation 17.05 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C5D1; Cognitive functioning | -0.26 units on a scale | Standard Deviation 14.28 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C6D1; Cognitive functioning | -0.77 units on a scale | Standard Deviation 15.98 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at STC/EW; Cognitive functioning | 1.04 units on a scale | Standard Deviation 18.28 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at EoCTR; Cognitive functioning | -0.27 units on a scale | Standard Deviation 16.94 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV1; Cognitive functioning | -0.26 units on a scale | Standard Deviation 15.98 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV2; Cognitive functioning | -2.38 units on a scale | Standard Deviation 18.17 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV3; Cognitive functioning | -2.96 units on a scale | Standard Deviation 18.24 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV4; Cognitive functioning | -1.77 units on a scale | Standard Deviation 19.11 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV5; Cognitive functioning | -6.14 units on a scale | Standard Deviation 21.67 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV6; Cognitive functioning | 0.00 units on a scale | Standard Deviation 0 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV7; Cognitive functioning | 0.00 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV8; Cognitive functioning | 0.00 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline; Social functioning | 85.51 units on a scale | Standard Deviation 21.18 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C1D1; Social functioning | -1.74 units on a scale | Standard Deviation 19.92 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C2D1; Social functioning | 0.25 units on a scale | Standard Deviation 18.46 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C3D1; Social functioning | 3.65 units on a scale | Standard Deviation 25.45 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C4D1; Social functioning | 4.62 units on a scale | Standard Deviation 20.09 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C5D1; Social functioning | 2.56 units on a scale | Standard Deviation 20.46 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C6D1; Social functioning | 3.85 units on a scale | Standard Deviation 24.61 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at STC/EW; Social functioning | 1.04 units on a scale | Standard Deviation 19.22 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at EoCTR; Social functioning | 1.88 units on a scale | Standard Deviation 20.49 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV1; Social functioning | 1.59 units on a scale | Standard Deviation 24.27 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV2; Social functioning | 1.32 units on a scale | Standard Deviation 27.97 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV3; Social functioning | 1.88 units on a scale | Standard Deviation 25.98 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV4; Social functioning | 1.06 units on a scale | Standard Deviation 32.12 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV5; Social functioning | 0.00 units on a scale | Standard Deviation 33.79 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV6; Social functioning | 10.00 units on a scale | Standard Deviation 14.91 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV7; Social functioning | 33.33 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV8; Social functioning | 33.33 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline; Global health status/QoL | 67.39 units on a scale | Standard Deviation 22.17 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline; Physical functioning | 83.77 units on a scale | Standard Deviation 15.27 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C1D1; Physical functioning | 1.39 units on a scale | Standard Deviation 12.9 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C2D1; Physical functioning | 2.99 units on a scale | Standard Deviation 12.83 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C3D1; Physical functioning | 1.46 units on a scale | Standard Deviation 14.76 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV2; Role functioning | -1.85 units on a scale | Standard Deviation 31.84 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C5D1; Physical functioning | 4.62 units on a scale | Standard Deviation 15.27 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C6D1; Physical functioning | 4.51 units on a scale | Standard Deviation 16.59 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at STC/EW; Physical functioning | 4.53 units on a scale | Standard Deviation 16.04 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at EoCTR; Physical functioning | 4.34 units on a scale | Standard Deviation 16.12 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV1; Physical functioning | 3.81 units on a scale | Standard Deviation 16.27 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV2; Physical functioning | 2.75 units on a scale | Standard Deviation 17.17 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV3; Physical functioning | 3.44 units on a scale | Standard Deviation 17.31 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV4; Physical functioning | 0.85 units on a scale | Standard Deviation 21.06 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV5; Physical functioning | -1.75 units on a scale | Standard Deviation 19.35 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV6; Physical functioning | 1.33 units on a scale | Standard Deviation 5.58 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV7; Physical functioning | 0.00 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV8; Physical functioning | 0.00 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Baseline; Role functioning | 83.82 units on a scale | Standard Deviation 21 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C1D1; Role functioning | -1.74 units on a scale | Standard Deviation 23.23 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C2D1; Role functioning | 2.49 units on a scale | Standard Deviation 23.07 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C3D1; Role functioning | 1.82 units on a scale | Standard Deviation 26.08 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C4D1; Role functioning | 5.13 units on a scale | Standard Deviation 22.03 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C5D1; Role functioning | 4.36 units on a scale | Standard Deviation 23.44 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C6D1; Role functioning | 1.79 units on a scale | Standard Deviation 25.71 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at STC/EW; Role functioning | 2.60 units on a scale | Standard Deviation 25.58 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at EoCTR; Role functioning | 2.12 units on a scale | Standard Deviation 26.69 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C1D1; Global health status/QoL | 6.34 units on a scale | Standard Deviation 18.41 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C2D1; Global health status/QoL | 5.35 units on a scale | Standard Deviation 20.14 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C3D1; Global health status/QoL | 2.21 units on a scale | Standard Deviation 23.58 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C4D1; Global health status/QoL | 7.05 units on a scale | Standard Deviation 21.05 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C5D1; Global health status/QoL | 7.18 units on a scale | Standard Deviation 21.94 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at C6D1; Global health status/QoL | 5.90 units on a scale | Standard Deviation 25.16 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at STC/EW; Global health status/QoL | 6.51 units on a scale | Standard Deviation 23.22 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at EoCTR; Global health status/QoL | 7.66 units on a scale | Standard Deviation 24.11 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV1; Global health status/QoL | 7.01 units on a scale | Standard Deviation 25.01 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV2; Global health status/QoL | 4.50 units on a scale | Standard Deviation 26.51 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV3; Global health status/QoL | 6.32 units on a scale | Standard Deviation 27.36 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV4; Global health status/QoL | 6.38 units on a scale | Standard Deviation 27.6 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV5; Global health status/QoL | 4.39 units on a scale | Standard Deviation 18.08 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV6; Global health status/QoL | 5.00 units on a scale | Standard Deviation 7.45 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV7; Global health status/QoL | 16.67 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV8; Global health status/QoL | 8.33 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score | Change at FUV1; Role functioning | 2.65 units on a scale | Standard Deviation 27.47 |
Secondary
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score
The EORTC QLQ-CLL16 module is designed for participants with Stage 0 to Stage 4 CLL. It is composed of 16 questions and there are four multi-item scales on Fatigue (2 items), Treatment-related side effects (TRSE, 4 items), Disease-related symptoms (DRS, 4 items), and Infection (4 items); and two single-item scales on social activities and future health worries. Multi-item scales score are reported and the total score for each multi-item scale was transformed to result in a total score range of 0 to 100, where higher score = poor HRQoL.
Time frame: Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days
Population: PRO evaluable population included all participants with baseline and at least one post-baseline PRO assessment. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Baseline; Infection | 15.92 units on a scale | Standard Deviation 17.63 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C4D1; TRSE | -0.49 units on a scale | Standard Deviation 13.97 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C5D1; TRSE | -0.51 units on a scale | Standard Deviation 14.57 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C6D1; TRSE | 0.46 units on a scale | Standard Deviation 15.51 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at STC/EW; TRSE | 0.81 units on a scale | Standard Deviation 18.11 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at EoCTR; TRSE | -0.88 units on a scale | Standard Deviation 16.06 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV1; TRSE | -1.20 units on a scale | Standard Deviation 14.87 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV2; TRSE | -1.70 units on a scale | Standard Deviation 15.28 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV3; TRSE | -2.08 units on a scale | Standard Deviation 12.64 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV4; TRSE | -1.97 units on a scale | Standard Deviation 12.76 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV5; TRSE | -2.68 units on a scale | Standard Deviation 11.02 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV6; TRSE | -1.01 units on a scale | Standard Deviation 12.1 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV7; TRSE | 2.56 units on a scale | Standard Deviation 22.67 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV8; TRSE | 1.67 units on a scale | Standard Deviation 13.69 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV9; TRSE | 8.33 units on a scale | Standard Deviation 11.79 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Baseline; DRS | 19.57 units on a scale | Standard Deviation 16.81 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C1D1; DRS | 0.0 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C2D1; DRS | -3.33 units on a scale | Standard Deviation 16.05 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C3D1; DRS | -4.77 units on a scale | Standard Deviation 16.49 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C4D1; DRS | -6.03 units on a scale | Standard Deviation 16.51 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C5D1; DRS | -5.90 units on a scale | Standard Deviation 16.73 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C6D1; DRS | -6.40 units on a scale | Standard Deviation 17.26 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at STC/EW; DRS | -5.80 units on a scale | Standard Deviation 18.52 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at EoCTR; DRS | -6.57 units on a scale | Standard Deviation 17.21 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV1; DRS | -6.55 units on a scale | Standard Deviation 15.73 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV2; DRS | -8.63 units on a scale | Standard Deviation 14.39 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV3; DRS | -7.37 units on a scale | Standard Deviation 14.88 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV4; DRS | -8.55 units on a scale | Standard Deviation 18.56 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV5; DRS | -8.33 units on a scale | Standard Deviation 16.13 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV6; DRS | -6.31 units on a scale | Standard Deviation 16.01 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV7; DRS | -15.38 units on a scale | Standard Deviation 20.08 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV8; DRS | -10.00 units on a scale | Standard Deviation 16.03 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV9; DRS | -4.17 units on a scale | Standard Deviation 5.89 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Baseline; Fatigue | 28.76 units on a scale | Standard Deviation 24.66 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C1D1; Fatigue | 0.0 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C2D1; Fatigue | -2.55 units on a scale | Standard Deviation 22.86 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C3D1; Fatigue | -2.83 units on a scale | Standard Deviation 25.17 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C4D1; Fatigue | -3.18 units on a scale | Standard Deviation 23.23 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C5D1; Fatigue | -2.38 units on a scale | Standard Deviation 27.52 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C6D1; Fatigue | -2.66 units on a scale | Standard Deviation 26.35 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at STC/EW; Fatigue | -3.11 units on a scale | Standard Deviation 28.64 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at EoCTR; Fatigue | -6.69 units on a scale | Standard Deviation 26.78 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV1; Fatigue | -6.37 units on a scale | Standard Deviation 26.61 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV2; Fatigue | -6.64 units on a scale | Standard Deviation 24.55 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV3; Fatigue | -5.79 units on a scale | Standard Deviation 23.29 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV4; Fatigue | -9.65 units on a scale | Standard Deviation 26.84 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV5; Fatigue | -6.55 units on a scale | Standard Deviation 25.56 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV6; Fatigue | -5.05 units on a scale | Standard Deviation 24.82 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV7; Fatigue | -10.26 units on a scale | Standard Deviation 30.08 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV8; Fatigue | -6.67 units on a scale | Standard Deviation 19 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV9; Fatigue | -8.33 units on a scale | Standard Deviation 11.79 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Baseline; TRSE | 14.29 units on a scale | Standard Deviation 13.95 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C1D1; Infection | 0.0 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C2D1; Infection | -0.02 units on a scale | Standard Deviation 19.98 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C3D1; Infection | -1.66 units on a scale | Standard Deviation 19.21 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C4D1; Infection | -1.44 units on a scale | Standard Deviation 22.07 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C5D1; Infection | -1.91 units on a scale | Standard Deviation 24 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C6D1; Infection | -1.09 units on a scale | Standard Deviation 20.66 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at STC/EW; Infection | -0.12 units on a scale | Standard Deviation 23.28 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at EoCTR; Infection | -0.55 units on a scale | Standard Deviation 21.73 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV1; Infection | 1.08 units on a scale | Standard Deviation 18.77 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV2; Infection | 0.05 units on a scale | Standard Deviation 23.29 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV3; Infection | -1.90 units on a scale | Standard Deviation 16.97 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV4; Infection | -4.24 units on a scale | Standard Deviation 16.71 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV5; Infection | -4.51 units on a scale | Standard Deviation 22.66 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV6; Infection | -1.60 units on a scale | Standard Deviation 18.9 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV7; Infection | -0.43 units on a scale | Standard Deviation 21.84 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV8; Infection | 8.89 units on a scale | Standard Deviation 23.36 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV9; Infection | -2.78 units on a scale | Standard Deviation 3.93 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C1D1; TRSE | 0.0 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C2D1; TRSE | 1.62 units on a scale | Standard Deviation 13.82 |
| Bendamustine + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C3D1; TRSE | -0.26 units on a scale | Standard Deviation 13.76 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Baseline; TRSE | 9.42 units on a scale | Standard Deviation 8.8 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV8; Fatigue | 0.00 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C1D1; TRSE | 0.12 units on a scale | Standard Deviation 10.1 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV4; Infection | 0.53 units on a scale | Standard Deviation 25.56 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C2D1; TRSE | 0.62 units on a scale | Standard Deviation 12.76 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Baseline; Fatigue | 21.74 units on a scale | Standard Deviation 20.67 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C3D1; TRSE | 1.98 units on a scale | Standard Deviation 14.72 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at EoCTR; Infection | -3.44 units on a scale | Standard Deviation 25.78 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C4D1; TRSE | 0.52 units on a scale | Standard Deviation 11.87 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C1D1; Fatigue | -2.24 units on a scale | Standard Deviation 20.29 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C5D1; TRSE | 0.64 units on a scale | Standard Deviation 10.02 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Baseline; Infection | 14.01 units on a scale | Standard Deviation 18.99 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C6D1; TRSE | -0.13 units on a scale | Standard Deviation 10.04 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C2D1; Fatigue | -5.47 units on a scale | Standard Deviation 21.4 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at STC/EW; TRSE | 0.13 units on a scale | Standard Deviation 10.76 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV8; Infection | -25.00 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at EoCTR; TRSE | 0.26 units on a scale | Standard Deviation 12.61 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C3D1; Fatigue | -3.17 units on a scale | Standard Deviation 23.73 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV1; TRSE | 1.19 units on a scale | Standard Deviation 12.24 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C1D1; Infection | -2.24 units on a scale | Standard Deviation 20.03 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV2; TRSE | 2.65 units on a scale | Standard Deviation 14.03 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C4D1; Fatigue | -4.17 units on a scale | Standard Deviation 22.02 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV3; TRSE | -0.13 units on a scale | Standard Deviation 13.7 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV1; Infection | -2.65 units on a scale | Standard Deviation 26.51 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV4; TRSE | 2.84 units on a scale | Standard Deviation 15.18 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C5D1; Fatigue | -4.36 units on a scale | Standard Deviation 20.89 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV5; TRSE | 1.32 units on a scale | Standard Deviation 10.49 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C2D1; Infection | -3.61 units on a scale | Standard Deviation 21.72 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV6; TRSE | -1.67 units on a scale | Standard Deviation 3.73 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C6D1; Fatigue | -2.31 units on a scale | Standard Deviation 21.42 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV7; TRSE | -8.33 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV5; Infection | 7.46 units on a scale | Standard Deviation 27.2 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV8; TRSE | 0.00 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at STC/EW; Fatigue | -4.69 units on a scale | Standard Deviation 21.3 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C3D1; Infection | -1.32 units on a scale | Standard Deviation 20.48 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Baseline; DRS | 16.95 units on a scale | Standard Deviation 17.37 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at EoCTR; Fatigue | -3.97 units on a scale | Standard Deviation 24.27 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C1D1; DRS | -2.74 units on a scale | Standard Deviation 16.18 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV2; Infection | -0.53 units on a scale | Standard Deviation 25.74 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C2D1; DRS | -4.77 units on a scale | Standard Deviation 16.84 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV1; Fatigue | -4.23 units on a scale | Standard Deviation 22.99 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C3D1; DRS | -3.35 units on a scale | Standard Deviation 17.48 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C4D1; Infection | -3.13 units on a scale | Standard Deviation 21.28 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C4D1; DRS | -5.12 units on a scale | Standard Deviation 17.72 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV2; Fatigue | -1.85 units on a scale | Standard Deviation 24.7 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C5D1; DRS | -4.79 units on a scale | Standard Deviation 17.5 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV7; Infection | -16.67 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C6D1; DRS | -5.30 units on a scale | Standard Deviation 16.72 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV3; Fatigue | -2.42 units on a scale | Standard Deviation 23.73 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at STC/EW; DRS | -6.51 units on a scale | Standard Deviation 18.45 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C5D1; Infection | -2.56 units on a scale | Standard Deviation 23.47 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at EoCTR; DRS | -5.86 units on a scale | Standard Deviation 20.38 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV4; Fatigue | -0.35 units on a scale | Standard Deviation 25.18 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV1; DRS | -5.82 units on a scale | Standard Deviation 19.2 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV3; Infection | -0.54 units on a scale | Standard Deviation 26.48 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV2; DRS | -3.57 units on a scale | Standard Deviation 18.31 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV5; Fatigue | 3.51 units on a scale | Standard Deviation 23.95 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV3; DRS | -3.76 units on a scale | Standard Deviation 19.25 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at C6D1; Infection | -2.95 units on a scale | Standard Deviation 20.54 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV4; DRS | -2.66 units on a scale | Standard Deviation 20.49 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV6; Fatigue | 3.33 units on a scale | Standard Deviation 24.72 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV5; DRS | -2.19 units on a scale | Standard Deviation 19.41 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV6; Infection | 8.33 units on a scale | Standard Deviation 15.59 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV6; DRS | -3.33 units on a scale | Standard Deviation 13.94 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV7; Fatigue | -33.33 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV7; DRS | -8.33 units on a scale | — |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at STC/EW; Infection | -1.69 units on a scale | Standard Deviation 23.34 |
| Venetoclax + Rituximab Main Study | Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score | Change at FUV8; DRS | -8.33 units on a scale | — |
Secondary
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores
MDASI is a 25-item validated questionnaire consisting of 2 parts. Part 1: 19-items divided into 2 scales, Core Symptom Severity (average of Questions 1 to 13; total 13 items: pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness) and Module Symptom Severity (average of Questions 14 to 19; total 6 items: night sweats, fevers and chills, lymph node swelling, diarrhea, bruising easy or bleeding, and constipation). Part 2: 6-items to assess Interference (symptom distress) (average of Questions 20 to 25; total 6 items: general activity, walking, work, mood, relations with other people, and enjoyment of life). Each item was rated from 0 to 10, with lower scores indicating better outcome. Total score for Core Symptom Severity, Module Symptom Severity, and Interference are reported which range from 0 to 10, with lower scores indicating better health-related quality of life (HRQoL).
Time frame: Baseline, Days 1, 8, and 15 of Cycles 1, 2, and 3; Cycle length = 28 days
Population: Patient reported outcomes (PRO) evaluable population included all participants with baseline and at least one post-baseline PRO assessment. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D8; Mean module symptom severity | -0.46 units on a scale | Standard Deviation 1.63 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D8; Mean core symptom severity | -0.13 units on a scale | Standard Deviation 1.63 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D15; Mean module symptom severity | -0.69 units on a scale | Standard Deviation 1.47 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D1; Mean core symptom severity | 0.00 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D1; Mean module symptom severity | -0.65 units on a scale | Standard Deviation 1.48 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D15; Mean core symptom severity | -0.42 units on a scale | Standard Deviation 1.52 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D8; Mean module symptom severity | -0.51 units on a scale | Standard Deviation 1.58 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D8; Mean core symptom severity | 0.17 units on a scale | Standard Deviation 1.59 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D15; Mean module symptom severity | -0.83 units on a scale | Standard Deviation 1.51 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Baseline; Mean module symptom severity | 1.60 units on a scale | Standard Deviation 1.46 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Baseline; Mean interference | 1.81 units on a scale | Standard Deviation 2.05 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D15; Mean core symptom severity | 0.00 units on a scale | Standard Deviation 1.31 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D1; Mean interference | 0.00 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D1; Mean module symptom severity | 0.00 units on a scale | Standard Deviation 0 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D8; Mean interference | 0.45 units on a scale | Standard Deviation 1.78 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D15; Mean core symptom severity | -0.13 units on a scale | Standard Deviation 1.53 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D15; Mean interference | 0.36 units on a scale | Standard Deviation 1.85 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D8; Mean module symptom severity | -0.22 units on a scale | Standard Deviation 1.4 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D1; Mean interference | 0.01 units on a scale | Standard Deviation 1.73 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D8; Mean core symptom severity | 0.26 units on a scale | Standard Deviation 1.34 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D8; Mean interference | 0.58 units on a scale | Standard Deviation 2.2 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D15; Mean module symptom severity | -0.43 units on a scale | Standard Deviation 1.51 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D15; Mean interference | 0.06 units on a scale | Standard Deviation 1.84 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D1; Mean core symptom severity | -0.26 units on a scale | Standard Deviation 1.6 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D1; Mean interference | -0.02 units on a scale | Standard Deviation 2.02 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D1; Mean module symptom severity | -0.49 units on a scale | Standard Deviation 1.46 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D8; Mean interference | 0.15 units on a scale | Standard Deviation 1.91 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D1; Mean core symptom severity | -0.23 units on a scale | Standard Deviation 1.3 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D15; Mean interference | -0.07 units on a scale | Standard Deviation 2.01 |
| Bendamustine + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Baseline; Mean core symptom severity | 1.76 units on a scale | Standard Deviation 1.55 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D15; Mean interference | -0.55 units on a scale | Standard Deviation 2.18 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Baseline; Mean core symptom severity | 1.55 units on a scale | Standard Deviation 1.31 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D1; Mean core symptom severity | -0.08 units on a scale | Standard Deviation 0.98 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D8; Mean core symptom severity | -0.30 units on a scale | Standard Deviation 0.84 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D15; Mean core symptom severity | -0.27 units on a scale | Standard Deviation 0.93 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D1; Mean core symptom severity | -0.33 units on a scale | Standard Deviation 0.91 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D8; Mean core symptom severity | -0.45 units on a scale | Standard Deviation 0.91 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D15; Mean core symptom severity | -0.53 units on a scale | Standard Deviation 0.9 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D1; Mean core symptom severity | -0.40 units on a scale | Standard Deviation 1.13 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D8; Mean core symptom severity | -0.66 units on a scale | Standard Deviation 1.2 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D15; Mean core symptom severity | -0.53 units on a scale | Standard Deviation 1.05 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Baseline; Mean module symptom severity | 1.57 units on a scale | Standard Deviation 1.11 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D1; Mean module symptom severity | -0.19 units on a scale | Standard Deviation 0.96 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D8; Mean module symptom severity | -0.53 units on a scale | Standard Deviation 0.96 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D15; Mean module symptom severity | -0.73 units on a scale | Standard Deviation 1.13 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D1; Mean module symptom severity | -0.65 units on a scale | Standard Deviation 0.92 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D8; Mean module symptom severity | -0.77 units on a scale | Standard Deviation 0.87 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D15; Mean module symptom severity | -0.94 units on a scale | Standard Deviation 0.93 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D1; Mean module symptom severity | -0.81 units on a scale | Standard Deviation 0.97 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D8; Mean module symptom severity | -0.83 units on a scale | Standard Deviation 0.97 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D15; Mean module symptom severity | -0.92 units on a scale | Standard Deviation 0.97 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Baseline; Mean interference | 1.90 units on a scale | Standard Deviation 2.25 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D1; Mean interference | -0.13 units on a scale | Standard Deviation 1.49 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D8; Mean interference | -0.29 units on a scale | Standard Deviation 2.14 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C1D15; Mean interference | 0.01 units on a scale | Standard Deviation 2.04 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D1; Mean interference | -0.34 units on a scale | Standard Deviation 1.78 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D8; Mean interference | -0.58 units on a scale | Standard Deviation 1.81 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C2D15; Mean interference | -0.64 units on a scale | Standard Deviation 1.59 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D1; Mean interference | -0.73 units on a scale | Standard Deviation 2.06 |
| Venetoclax + Rituximab Main Study | Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores | Change at C3D8; Mean interference | -0.82 units on a scale | Standard Deviation 2.09 |
Secondary
Duration of Responses (DOR) as Assessed by the Investigator Using iwCLL Guidelines
DOR was defined as the time from first occurrence of a documented response of CR, CRi, nPR, or PR until PD/relapse, as assessed by the investigator according to the iwCLL guidelines, or death from any cause. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants without PD or death after response were censored at the last date of adequate response assessment. The median DOR was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. CR, CRi, nPR, and PR have been defined in previous outcomes, and are not repeated here due to space constraint.
Time frame: From time of achieving best overall response until PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)
Population: Analysis was performed on ITT population participants who had best overall response of CR, CRi, nPR, or PR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Duration of Responses (DOR) as Assessed by the Investigator Using iwCLL Guidelines | 19.1 months |
| Venetoclax + Rituximab Main Study | Duration of Responses (DOR) as Assessed by the Investigator Using iwCLL Guidelines | 53.6 months |
Secondary
Event-Free Survival (EFS) as Assessed by the Investigator Using iwCLL Guidelines
EFS was defined as the time from date of randomization until the date of PD/relapse, start of a new non-protocol-specified anti-CLL therapy, or death from any cause, whichever occurred first, as assessed by the investigator. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants without any of the specified event at the time of analysis were censored at the date of last adequate response assessment. In case of no post-baseline response assessment, participants were censored at the randomization date. The median EFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.
Time frame: Baseline up to PD/relapse, start of a new anti-CLL therapy, or death from any cause, whichever occurred first (approximately 8 years 5 months)
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Event-Free Survival (EFS) as Assessed by the Investigator Using iwCLL Guidelines | 16.4 months |
| Venetoclax + Rituximab Main Study | Event-Free Survival (EFS) as Assessed by the Investigator Using iwCLL Guidelines | 53.7 months |
Comparison: Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.p-value: <0.000195% CI: [0.17, 0.29]Log Rank
Comparison: Unstratified Analysisp-value: <0.000195% CI: [0.19, 0.31]Log Rank
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above. AEs were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE, v4.0)
Time frame: From signing of informed consent form up to approximately 8 years 5 months
Population: SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bendamustine + Rituximab Main Study | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse Events | 185 Participants |
| Bendamustine + Rituximab Main Study | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Serious Adverse Events | 84 Participants |
| Venetoclax + Rituximab Main Study | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse Events | 194 Participants |
| Venetoclax + Rituximab Main Study | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Serious Adverse Events | 101 Participants |
Secondary
Number of Participants With Grade 3 or Higher Tumor Lysis Syndrome (TLS) and Infusion-related Reactions (IRRs)
An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A SAE is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above. TLS and IRRs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant; Grade 4 = Life-threatening; Grade 5 = Death. A higher grade indicates a worse outcome.
Time frame: From signing of informed consent form up to approximately 8 years 5 months
Population: SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bendamustine + Rituximab Main Study | Number of Participants With Grade 3 or Higher Tumor Lysis Syndrome (TLS) and Infusion-related Reactions (IRRs) | TLS | 2 Participants |
| Bendamustine + Rituximab Main Study | Number of Participants With Grade 3 or Higher Tumor Lysis Syndrome (TLS) and Infusion-related Reactions (IRRs) | IRRs | 10 Participants |
| Venetoclax + Rituximab Main Study | Number of Participants With Grade 3 or Higher Tumor Lysis Syndrome (TLS) and Infusion-related Reactions (IRRs) | TLS | 6 Participants |
| Venetoclax + Rituximab Main Study | Number of Participants With Grade 3 or Higher Tumor Lysis Syndrome (TLS) and Infusion-related Reactions (IRRs) | IRRs | 4 Participants |
Secondary
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator. The median OS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.
Time frame: Baseline up to approximately 8 years 5 months
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Overall Survival (OS) | 87.8 months |
| Venetoclax + Rituximab Main Study | Overall Survival (OS) | NA months |
p-value: 0.000295% CI: [0.37, 0.74]Log Rank
Comparison: Unstratified Analysisp-value: 0.000395% CI: [0.39, 0.76]Log Rank
Secondary
Percentage of Participants Who Died
Percentage of participants who died from any cause, during the study, was reported. Percentage is rounded off.
Time frame: Baseline up to approximately 8 years 5 months
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants Who Died | 43.1 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants Who Died | 30.9 percentage of participants |
Secondary
Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines
Response was assessed by investigator according to iwCLL guidelines and was confirmed by repeat assessment \>/=4 weeks after initial documentation. CR: peripheral blood lymphocytes \<4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with \<30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: \>/=50% reduction in two of following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and 1 of following: neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL or \>/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. 95% CI was computed using Pearson-Clopper method.Percentages are rounded off.
Time frame: Baseline up to approximately 8 years 5 months
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines | CR | 8.2 percentage of participants |
| Bendamustine + Rituximab Main Study | Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines | CRi | 0.5 percentage of participants |
| Bendamustine + Rituximab Main Study | Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines | nPR | 6.2 percentage of participants |
| Bendamustine + Rituximab Main Study | Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines | PR | 52.8 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines | PR | 61.9 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines | CR | 26.3 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines | nPR | 3.6 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines | CRi | 1.5 percentage of participants |
p-value: <0.000195% CI: [17.88, 33.33]Cochran-Mantel-Haenszel
95% CI: [3.97, 15.37]
Secondary
Percentage of Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the IRC Using iwCLL Guidelines
Response was assessed by IRC according to iwCLL guidelines and was confirmed by repeat assessment \>/=4 weeks after initial documentation. CR: peripheral blood lymphocytes \<4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, constitutional symptoms; neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with \<30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: \>/=50% reduction in 2 of following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; 1 of following: neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL or \>/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. 95% CI was computed using Pearson-Clopper method.No new IRC data was generated post primary analysis.
Time frame: Baseline up to last FUV (up to approximately 3 years)
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the IRC Using iwCLL Guidelines | 67.7 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the IRC Using iwCLL Guidelines | 93.3 percentage of participants |
p-value: <0.000195% CI: [17.88, 33.33]Cochran-Mantel-Haenszel
95% CI: [3.97, 15.37]
Secondary
Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood
MRD-negativity was defined as the presence of \<1 malignant B-cell per 10000 normal B-cells in a sample of at least 200000 B-cells, as assessed by the allele specific oligonucleotide polymerase chain reaction (ASO-PCR) and/or flow cytometry technique. Percentage of participants with MRD-negativity was reported. The 95% CI was computed using Pearson-Clopper method. Percentage is rounded off.
Time frame: EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood | 13.3 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood | 62.4 percentage of participants |
p-value: <0.000195% CI: [40.44, 57.64]Chi-squared
95% CI: [6.5, 17.85]
Secondary
Percentage of Participants With MRD Negativity in Bone Marrow
MRD-negativity was defined as the presence of \<1 malignant B-cell per 10000 normal B-cells in a sample of at least 200000 B-cells, as assessed flow cytometry technique. Percentage of participants with MRD-negativity was reported. The 95% CI was computed using Pearson-Clopper method. Percentages are rounded off.
Time frame: EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With MRD Negativity in Bone Marrow | 1.0 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With MRD Negativity in Bone Marrow | 14.4 percentage of participants |
p-value: <0.000195% CI: [7.99, 18.82]Chi-squared
95% CI: [3.82, 69.35]
Secondary
Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the Investigator Using iwCLL Guidelines
Response was assessed by investigator according to iwCLL guidelines and was confirmed by repeat assessment \>/=4 weeks after initial documentation. CR: peripheral blood lymphocytes \<4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with \<30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: \>/=50% reduction in 2 of following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and 1 of following: neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL or \>/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. 95% CI was computed using Pearson-Clopper method. Percentages are rounded off.
Time frame: End of combination treatment response (EoCTR) visit (8 to 12 weeks after Cycle [C] 6 Day [1]); Cycle length = 28 days
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the Investigator Using iwCLL Guidelines | 63.1 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the Investigator Using iwCLL Guidelines | 88.1 percentage of participants |
p-value: <0.000195% CI: [16.63, 33.51]Cochran-Mantel-Haenszel
95% CI: [2.68, 7.88]
Secondary
Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the IRC Using iwCLL Guidelines
Response was assessed by the IRC according to the iwCLL guidelines and was confirmed by repeat assessment \>/=4 weeks after initial documentation. CR: peripheral blood lymphocytes \<4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with \<30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: \>/=50% reduction in two of the following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and one of the following: neutrophils \>1500/mcL, platelets \>100000/mcL, hemoglobin \>11.0 g/dL or \>/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. The 95% CI was computed using Pearson-Clopper method.
Time frame: EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the IRC Using iwCLL Guidelines | 62.6 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the IRC Using iwCLL Guidelines | 87.1 percentage of participants |
p-value: <0.000195% CI: [16, 33.1]Cochran-Mantel-Haenszel
95% CI: [2.68, 7.85]
Secondary
Percentage of Participants With PD or Death Among Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the Investigator Using iwCLL Guidelines
Percentage of participants with PD as assessed by the investigator according to the iwCLL guidelines or death from any cause during the study was reported. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; an increase of \>/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 g/dL or to \<10 g/dL. CR, CRi, nPR, and PR have been defined in previous outcomes, and are not repeated here due to space constraint. Percentage is rounded off.
Time frame: From time of achieving best overall response until PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)
Population: Analysis was performed on ITT population participants who had best overall response of CR, CRi, nPR, or PR.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With PD or Death Among Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the Investigator Using iwCLL Guidelines | 95.5 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With PD or Death Among Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the Investigator Using iwCLL Guidelines | 68.5 percentage of participants |
Secondary
Percentage of Participants With PD or Death as Assessed by the Independent Review Committee (IRC) Using Standard iwCLL Guidelines
Assessment of response was performed by the IRC according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; an increase of \>/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 g/dL or to \<10 g/dL. No new IRC data was generated post the primary analysis.
Time frame: Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With PD or Death as Assessed by the Independent Review Committee (IRC) Using Standard iwCLL Guidelines | 54.4 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With PD or Death as Assessed by the Independent Review Committee (IRC) Using Standard iwCLL Guidelines | 18.0 percentage of participants |
Secondary
Percentage of Participants With PD or Death as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by Fluorescence In-situ Hybridization (FISH) Test
Assessment of response was performed by the investigator according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; an increase of \>/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 g/dL or to \<10 g/dL. Percentages are rounded off.
Time frame: Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)
Population: Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With PD or Death as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by Fluorescence In-situ Hybridization (FISH) Test | 80.4 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With PD or Death as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by Fluorescence In-situ Hybridization (FISH) Test | 80.4 percentage of participants |
Secondary
Percentage of Participants With PD or Death as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test
Assessment of response was performed by the IRC according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; an increase of \>/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 g/dL or to \<10 g/dL. No new IRC data was generated post the primary analysis.
Time frame: Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
Population: Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With PD or Death as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test | 47.8 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With PD or Death as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test | 19.6 percentage of participants |
Secondary
Percentage of Participants With PD/Relapse, Start of a New Anti-Chronic Lymphocytic Leukemia (CLL) Therapy, or Death as Assessed by the Investigator Using iwCLL Guidelines
Percentage of participants with PD/relapse, death from any cause, or start of a new non-protocol-specified anti-CLL therapy as assessed by the investigator, during the study, was reported. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; an increase of \>/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 g/dL or to \<10 g/dL. Percentages are rounded off.
Time frame: Baseline up to PD/relapse, start of a new anti-CLL therapy, or death from any cause, whichever occurred first (approximately 8 years 5 months)
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With PD/Relapse, Start of a New Anti-Chronic Lymphocytic Leukemia (CLL) Therapy, or Death as Assessed by the Investigator Using iwCLL Guidelines | 89.2 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With PD/Relapse, Start of a New Anti-Chronic Lymphocytic Leukemia (CLL) Therapy, or Death as Assessed by the Investigator Using iwCLL Guidelines | 71.1 percentage of participants |
Secondary
Percentage of Participants With Start of New Anti-CLL Treatment or Death as Assessed by the Investigator
Percentage of participants with start of new non-protocol-specified anti-CLL therapy, as assessed by the investigator, or death from any cause, during the study, was reported. Percentage is rounded off.
Time frame: Baseline up to start of new ani-CLL therapy or death, whichever occurred first (up to approximately 8 years 5 months)
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Percentage of Participants With Start of New Anti-CLL Treatment or Death as Assessed by the Investigator | 81.5 percentage of participants |
| Venetoclax + Rituximab Main Study | Percentage of Participants With Start of New Anti-CLL Treatment or Death as Assessed by the Investigator | 62.4 percentage of participants |
Secondary
PFS as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test
PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the investigator using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.
Time frame: Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)
Population: Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine + Rituximab Main Study | PFS as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test | 15.4 months |
| Venetoclax + Rituximab Main Study | PFS as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test | 47.9 months |
Comparison: Stratified Analysis; Stratification factor: geographic region.p-value: <0.000195% CI: [0.21, 0.57]Log Rank
Comparison: Unstratified Analysisp-value: <0.000195% CI: [0.22, 0.56]Log Rank
Secondary
PFS as Assessed by the IRC Using Standard iwCLL Guidelines
PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. No new IRC data was generated post the primary analysis.
Time frame: Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine + Rituximab Main Study | PFS as Assessed by the IRC Using Standard iwCLL Guidelines | 18.1 months |
| Venetoclax + Rituximab Main Study | PFS as Assessed by the IRC Using Standard iwCLL Guidelines | NA months |
Comparison: Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.p-value: <0.000195% CI: [0.13, 0.28]Log Rank
Comparison: Unstratified Analysisp-value: <0.000195% CI: [0.14, 0.3]Log Rank
Secondary
PFS as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test
PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (\>1.5 cm); unequivocal progression of non-target lesion; increase of \>/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count \>/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of \>/=50% in platelet or neutrophil count, or hemoglobin level by \>2 g/dL or to \<10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. No new IRC data was generated post the primary analysis.
Time frame: Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
Population: Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine + Rituximab Main Study | PFS as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test | 16.1 months |
| Venetoclax + Rituximab Main Study | PFS as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test | NA months |
Comparison: Stratified Analysis; Stratification factor: geographic region.p-value: <0.000195% CI: [0.09, 0.49]Log Rank
Comparison: Unstratified Analysisp-value: <0.000195% CI: [0.09, 0.46]Log Rank
Secondary
Plasma Venetoclax Concentrations
Time frame: Pre-dose (0 hour, anytime before venetoclax administration) and 4 hours post-dose on D1 of Cycles 1 and 4; Cycle length = 28 days
Population: Pharmacokinetic (PK) evaluable population included all participants in the 'Venetoclax + Rituximab' arm who received at least one dose of venetoclax with at least one post-dose PK concentration result available. Here 'Number Analyzed' signifies the number of participants evaluable at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine + Rituximab Main Study | Plasma Venetoclax Concentrations | C4D1, 4 hours Post-Dose | 1.34 micrograms per milliliter (mcg/mL) | Standard Deviation 0.905 |
| Bendamustine + Rituximab Main Study | Plasma Venetoclax Concentrations | C1D1, Pre-dose | 0.626 micrograms per milliliter (mcg/mL) | Standard Deviation 0.54 |
| Bendamustine + Rituximab Main Study | Plasma Venetoclax Concentrations | C1D1, 4 hours Post-Dose | 1.34 micrograms per milliliter (mcg/mL) | Standard Deviation 0.881 |
| Bendamustine + Rituximab Main Study | Plasma Venetoclax Concentrations | C4D1, Pre-dose | 0.681 micrograms per milliliter (mcg/mL) | Standard Deviation 0.745 |
Secondary
Time to New Anti-CLL Treatment (TTNT) as Assessed by the Investigator
TTNT was defined as the time from randomization until start of new non-protocol-specified anti-CLL treatment or death from any cause. Participants without the event at the time of analysis were censored at the last visit date for this outcome measure analysis. The median TTNT was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.
Time frame: Baseline up to start of new ani-CLL therapy or death, whichever occurred first (up to approximately 8 years 5 months)
Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine + Rituximab Main Study | Time to New Anti-CLL Treatment (TTNT) as Assessed by the Investigator | 24.0 months |
| Venetoclax + Rituximab Main Study | Time to New Anti-CLL Treatment (TTNT) as Assessed by the Investigator | 63.0 months |
Comparison: Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.p-value: <0.000195% CI: [0.23, 0.39]Log Rank
Comparison: Unstratified Analysisp-value: <0.000195% CI: [0.25, 0.41]Log Rank
Other Pre-specified
Change From Baseline in Lymphocyte Subset Counts at Specified Time Points
Time frame: Baseline, C4D14-28, Study Treatment Completion/Early Withdrawal (STC/EW, up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and at FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days
Post Hoc
Euro QoL 5 Dimension (EQ-5D) Questionnaire Score
Time frame: Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days