Non-Hodgkin's Lymphoma
Conditions
Keywords
follicular, follicular lymphoma
Brief summary
This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).
Interventions
DRUGObinutuzumab
IV infusion.
DRUGBendamustine
IV infusion.
Sponsors
Roche Pharma AG
Genentech, Inc.
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
* History of histologically documented, B-lymphocyte antigen cluster of differentiation 20 plus (CD20+), iNHL * Refractory to any previous regimen containing rituximab (defined by participants who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen) * Previously treated with a maximum of four unique chemotherapy containing treatment regimens * All participants must have at least one bi-dimensionally measurable lesion (greater than \[\>\]1.5 centimeters (cm) in its largest dimension by computed tomography \[CT\] scan)
Exclusion criteria
* Prior use of any monoclonal antibody (other than anti-CD20) within 3 months prior to the start of Cycle 1, prior treatment with obinutuzumab was not allowed * Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1 * Prior treatment with bendamustine (within 2 years of the start of Cycle 1) * Prior allogeneic stem cell transplant * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy * History of sensitivity to mannitol * Central nervous system lymphoma or prior diffuse large B-cell lymphoma (DLBCL), histological evidence of transformation to high grade or diffuse large B-cell lymphoma * History of other malignancy that could affect compliance with the protocol or interpretation of results * Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results * Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 4 weeks * Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML) * Vaccination with a live vaccine a minimum of 28 days prior to randomization * Recent major surgery (within 4 weeks), other than for diagnosis * Presence of positive test results for Hepatitis B surface antigen (HBsAg); antibody to hepatitis B core antigen \[anti-HBc\]) with detectable viral load (positive hepatitis B virus \[HBV\] deoxyribo-nucleic acid \[DNA\]) or Hepatitis C * Participants with chronic hepatitis B or seropositive occult (HBV) infection * Participants with seronegative occult HBV infection or past HBV infection (defined as anti-HBc positive and HBV DNA negative) could be eligible if they were willing to be followed according to the protocol for HBV DNA testing * Participants positive for Hepatitis C virus (HCV) antibody were eligible only if polymerase chain reaction(PCR) was negative for HCV Ribonucleic acid (RNA) * Known history of human immunodeficiency virus (HIV) seropositive status * Positive test results for human T-lymphotropic virus type I (HTLV 1) virus in endemic countries * Women who are pregnant or lactating * Fertile men or women of childbearing potential unless 1) surgically sterile or 2) using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly * Ongoing corticosteroid use \>30 milligrams per day (mg/day) prednisone or equivalent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death | Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall]) | PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (\<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (\>) 1 cm in its short axis. |
| Progression-Free Survival (PFS) as Assessed by IRC | Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall]) | PFS was defined as the time from randomization to the first occurrence of PD or death as assessed by an IRC according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be PD, a lymph node with a diameter of the short axis of \<1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node \>1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Objective Response as Assessed by IRC | Baseline until PD or death, whichever occurred first (up to approximately 5 years) | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015. |
| Percentage of Participants With Objective Response as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. |
| Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | Baseline until PD or death, whichever occurred first (up to approximately 5 years) | BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan & no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions (e.g., splenic or hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015. |
| Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) | BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). |
| Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) | BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan & no new sites; no increase in size of other nodes, liver or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or size of other lesions (e.g., splenic/hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015. |
| Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) | BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). |
| Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015. |
| Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator | Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1) | Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. |
| Duration of Response (DoR) as Assessed by IRC | Baseline until PD or death, whichever occurred first (up to approximately 5 years) | DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable evidence of disease & disease-related symptoms if present before therapy; liver, spleen returned to normal size; if bone marrow involved by lymphoma before treatment, infiltrate must be cleared on repeat bone marrow biopsy. PR: at least 50% measurable disease regressed vs. to baseline scan and no new sites; no increase in size of other nodes/liver/spleen, exception: splenic, hepatic nodules; other organs involved is usually assessable; no measurable disease present. PD: any new lesion \>1.5 cm in any axis appear during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR estimated using Kaplan-Meier method. IRC review performed up to clinical cutoff date 1 May 2015. |
| Duration of Response (DoR) as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) | DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy; liver, spleen returned to normal size (if enlarged at baseline); if bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic, hepatic nodules; involvement of other organs is usually assessable; no presence of measurable disease. PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR was estimated using Kaplan-Meier method. |
| Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC | Baseline until PD or death, whichever occurred first (up to approximately 5 years) | DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL \[Modified Cheson et al, 2007\]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015. |
| Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to approximately 8.5 years) | DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL \[Modified Cheson et al, 2007\]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method. |
| Event-free Survival (EFS) as Assessed by IRC | Baseline until PD or death, whichever occurred first (up to approximately 5 years) | EFS was defined as the time between the date of randomization and the date of PD/relapse based on IRC assessments (as per modified response criteria for iNHL \[Modified Cheson et al, 2007\]), death from any cause on study, or start of a new anti-lymphoma therapy. PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. EFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015. |
| Percentage of Participants Who Died | Baseline until death (up to 8.5 years overall) | — |
| Number of Participants With PD or Death as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to 8.5 years overall)) | PD was assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of \<1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node \>1 cm in its short axis. |
| Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (QoL). In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). |
| CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). |
| CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). |
| CFB in FACT-Lym-Functional Well-Being Sub-scale Score | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). |
| CFB in FACT-Lym-Lymphoma Sub-scale Score | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 | The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). |
| CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under CFB at Follow-up Month 2 and CFB at Follow-up Month 4 categories. |
| CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase. |
| CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under CFB at Follow-up Month 2 and CFB at Follow-up Month 4 categories. |
| CFB in EQ-5D VAS Score During Maintenance Phase | Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase. |
| CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 | The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). |
| CFB in FACT-Lym Trial Outcome Index (TOI) | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 | TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). |
| CFB in FACT-Lym Total Score | Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24 | FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). |
| Time to Deterioration of FACT-Lym TOI | Baseline up to approximately 8.5 years | The median time, in month, from date of randomization until a clinically meaningful decline from baseline in TOI or death, whichever occurred first. TOI: sum of physical well-being score,functional well-being score, and Lymphoma sub-scale of FACT-Lym; total 29 items, responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from baseline. Time to deterioration was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. In timeframe, follow-up months represents months after end of induction (EOI) (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up). |
| Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), 12 (FUM12), 18 (FUM18), 24 (FUM24), Extension Follow Up Month 6 (Extension FUM6) | FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0-116). FACT-Lym total score is sum of 42 items (total score ranges from 0-168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6). |
| Overall Survival (OS) | Baseline until death (up to 8.5 years overall) | OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. |
| PFS as Assessed by Investigator | Baseline until PD or death, whichever occurred first (up to 8.5 years overall) | PFS was defined as the time from randomization to the first occurrence of PD as assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007), or death from any cause on study. PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of \<1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node \>1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. |
Countries
Austria, Belgium, Canada, Czechia, France, Germany, Italy, Netherlands, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bendamustine Alone Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles. | 209 |
| Obinutuzumab + Bendamustine Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first). | 204 |
| Total | 413 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 100 | 84 |
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Physician Decision | 2 | 4 |
| Overall Study | Withdrawal by Subject | 21 | 14 |
Baseline characteristics
| Characteristic | Total | Obinutuzumab + Bendamustine | Bendamustine Alone |
|---|---|---|---|
| Age, Continuous | 61.9 Years STANDARD_DEVIATION 11.4 | 62.0 Years STANDARD_DEVIATION 11.3 | 61.9 Years STANDARD_DEVIATION 11.5 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 8 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 11 Participants | 6 Participants | 5 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 357 Participants | 183 Participants | 174 Participants |
| Race/Ethnicity, Customized Not Stated | 45 Participants | 15 Participants | 30 Participants |
| Race/Ethnicity, Customized Unknown | 31 Participants | 12 Participants | 19 Participants |
| Race/Ethnicity, Customized White | 361 Participants | 180 Participants | 181 Participants |
| Sex: Female, Male Female | 175 Participants | 88 Participants | 87 Participants |
| Sex: Female, Male Male | 238 Participants | 116 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 194 / 203 | 200 / 204 |
| serious Total, serious adverse events | 76 / 203 | 91 / 204 |
Outcome results
Primary
Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death
PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (\<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (\>) 1 cm in its short axis.
Time frame: Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine Alone | Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death | 125 participants |
| Obinutuzumab + Bendamustine | Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death | 87 participants |
Primary
Progression-Free Survival (PFS) as Assessed by IRC
PFS was defined as the time from randomization to the first occurrence of PD or death as assessed by an IRC according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be PD, a lymph node with a diameter of the short axis of \<1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node \>1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.
Time frame: Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])
Population: ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine Alone | Progression-Free Survival (PFS) as Assessed by IRC | 14.1 months |
| Obinutuzumab + Bendamustine | Progression-Free Survival (PFS) as Assessed by IRC | 29.2 months |
p-value: <0.000195% CI: [0.4, 0.7]Log Rank
Secondary
CFB in EQ-5D VAS Score During Maintenance Phase
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.
Time frame: Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6)
Population: ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and n signified those participants who were evaluable for a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine Alone | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 8 | 5.00 units on a scale | — |
| Bendamustine Alone | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 6 | 5.00 units on a scale | — |
| Bendamustine Alone | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 10 | -15.00 units on a scale | — |
| Bendamustine Alone | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 4 | 5.00 units on a scale | — |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 10 | 4.62 units on a scale | Standard Deviation 16.28 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 12 | 5.73 units on a scale | Standard Deviation 16.04 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 14 | 5.45 units on a scale | Standard Deviation 17.36 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 16 | 6.66 units on a scale | Standard Deviation 17.44 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 18 | 6.13 units on a scale | Standard Deviation 19.44 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 20 | 7.56 units on a scale | Standard Deviation 15.43 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 22 | 6.97 units on a scale | Standard Deviation 15.55 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 24 | 8.28 units on a scale | Standard Deviation 16.23 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 2 | -40.00 units on a scale | — |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Final Follow-up | 4.47 units on a scale | Standard Deviation 14.91 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 4 | 5.59 units on a scale | Standard Deviation 19.61 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 6 | 6.04 units on a scale | Standard Deviation 19 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D VAS Score During Maintenance Phase | CFB at Follow-up Month 8 | 4.79 units on a scale | Standard Deviation 17.18 |
Secondary
CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under CFB at Follow-up Month 2 and CFB at Follow-up Month 4 categories.
Time frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14
Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and n signified those participants who were evaluable for a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine Alone | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | Baseline | 69.48 units on a scale | Standard Deviation 20.71 |
| Bendamustine Alone | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | CFB at Cycle 3 Day 1 | 0.91 units on a scale | Standard Deviation 19.38 |
| Bendamustine Alone | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | CFB at Cycle 4 Day 1 | -14.00 units on a scale | Standard Deviation 33.29 |
| Bendamustine Alone | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | CFB at Cycle 5 Day 1 | 0.35 units on a scale | Standard Deviation 20.79 |
| Bendamustine Alone | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | CFB at End of Induction Treatment | 5.71 units on a scale | Standard Deviation 61.88 |
| Bendamustine Alone | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | CFB at Follow-up Month 2 | 5.19 units on a scale | Standard Deviation 19.12 |
| Bendamustine Alone | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | CFB at Follow-up Month 14 | 10.00 units on a scale | — |
| Obinutuzumab + Bendamustine | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | CFB at Cycle 5 Day 1 | 5.17 units on a scale | Standard Deviation 17.35 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | Baseline | 68.03 units on a scale | Standard Deviation 21.69 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | CFB at Follow-up Month 2 | 6.85 units on a scale | Standard Deviation 18.95 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | CFB at Cycle 3 Day 1 | 3.32 units on a scale | Standard Deviation 15.99 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | CFB at End of Induction Treatment | 5.82 units on a scale | Standard Deviation 22.2 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | CFB at Cycle 4 Day 1 | -4.33 units on a scale | Standard Deviation 42.15 |
| Obinutuzumab + Bendamustine | CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase | CFB at Follow-up Month 4 | 0.00 units on a scale | Standard Deviation 14.14 |
Secondary
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.
Time frame: Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6)
Population: ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and n signified those participants who were evaluable for a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine Alone | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 8 | 0.15 units on a scale | — |
| Bendamustine Alone | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 6 | 0.15 units on a scale | — |
| Bendamustine Alone | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 10 | 0.15 units on a scale | — |
| Bendamustine Alone | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 4 | 0.15 units on a scale | — |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 10 | 0.03 units on a scale | Standard Deviation 0.2 |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 12 | 0.06 units on a scale | Standard Deviation 0.18 |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 14 | 0.06 units on a scale | Standard Deviation 0.19 |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 16 | 0.05 units on a scale | Standard Deviation 0.19 |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 18 | 0.05 units on a scale | Standard Deviation 0.18 |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 20 | 0.05 units on a scale | Standard Deviation 0.2 |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 22 | 0.05 units on a scale | Standard Deviation 0.24 |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 24 | 0.03 units on a scale | Standard Deviation 0.22 |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 2 | -0.15 units on a scale | Standard Deviation 0.22 |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Final Follow-up | 0.03 units on a scale | Standard Deviation 0.25 |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 4 | 0.03 units on a scale | Standard Deviation 0.22 |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 6 | 0.04 units on a scale | Standard Deviation 0.19 |
| Obinutuzumab + Bendamustine | CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase | CFB at Follow-up Month 8 | 0.04 units on a scale | Standard Deviation 0.21 |
Secondary
CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under CFB at Follow-up Month 2 and CFB at Follow-up Month 4 categories.
Time frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14
Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and n signified those participants who were evaluable for a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine Alone | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | Baseline | 0.77 units on a scale | Standard Deviation 0.22 |
| Bendamustine Alone | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | CFB at Cycle 3 Day 1 | 0.03 units on a scale | Standard Deviation 0.21 |
| Bendamustine Alone | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | CFB at Cycle 4 Day 1 | -0.10 units on a scale | Standard Deviation 0.23 |
| Bendamustine Alone | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | CFB at Cycle 5 Day 1 | 0.01 units on a scale | Standard Deviation 0.21 |
| Bendamustine Alone | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | CFB at End of Induction Treatment | 0.01 units on a scale | Standard Deviation 0.22 |
| Bendamustine Alone | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | CFB at Follow-up Month 2 | 0.06 units on a scale | Standard Deviation 0.24 |
| Bendamustine Alone | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | CFB at Follow-up Month 14 | 0.12 units on a scale | — |
| Obinutuzumab + Bendamustine | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | CFB at Cycle 5 Day 1 | 0.02 units on a scale | Standard Deviation 0.2 |
| Obinutuzumab + Bendamustine | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | Baseline | 0.79 units on a scale | Standard Deviation 0.2 |
| Obinutuzumab + Bendamustine | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | CFB at Follow-up Month 2 | 0.04 units on a scale | Standard Deviation 0.18 |
| Obinutuzumab + Bendamustine | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | CFB at Cycle 3 Day 1 | 0.00 units on a scale | Standard Deviation 0.19 |
| Obinutuzumab + Bendamustine | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | CFB at End of Induction Treatment | 0.01 units on a scale | Standard Deviation 0.2 |
| Obinutuzumab + Bendamustine | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | CFB at Cycle 4 Day 1 | -0.07 units on a scale | Standard Deviation 0.41 |
| Obinutuzumab + Bendamustine | CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase | CFB at Follow-up Month 4 | -0.12 units on a scale | Standard Deviation 0 |
Secondary
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score
The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and n signified those participants who were evaluable for a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Final Follow-up | 0.38 units on a scale | Standard Deviation 3.77 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | Baseline | 17.38 units on a scale | Standard Deviation 4.45 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Cycle 3 Day 1 | 0.61 units on a scale | Standard Deviation 3.04 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Cycle 4 Day 1 | -0.60 units on a scale | Standard Deviation 3.85 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Cycle 5 Day 1 | 0.37 units on a scale | Standard Deviation 3.08 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at End of Induction Treatment | 0.53 units on a scale | Standard Deviation 3.57 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 2 | 0.66 units on a scale | Standard Deviation 3.89 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 4 | 1.34 units on a scale | Standard Deviation 3.54 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 6 | 0.89 units on a scale | Standard Deviation 3.57 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 8 | 0.26 units on a scale | Standard Deviation 3.35 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 10 | 0.69 units on a scale | Standard Deviation 3.31 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 12 | -0.07 units on a scale | Standard Deviation 3.88 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 14 | 0.46 units on a scale | Standard Deviation 3.22 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 16 | 0.13 units on a scale | Standard Deviation 3.87 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 18 | 0.42 units on a scale | Standard Deviation 3.36 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 20 | -0.43 units on a scale | Standard Deviation 2.9 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 22 | 0.18 units on a scale | Standard Deviation 2.81 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 24 | 0.06 units on a scale | Standard Deviation 3.2 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Extension Follow-up Month 6 | -0.44 units on a scale | Standard Deviation 3.26 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Extension Follow-up Month 18 | -0.08 units on a scale | Standard Deviation 3.8 |
| Bendamustine Alone | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Extension Follow-up Month 24 | 1.04 units on a scale | Standard Deviation 4.16 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 22 | 0.97 units on a scale | Standard Deviation 3.79 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 12 | 0.95 units on a scale | Standard Deviation 3.29 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | Baseline | 17.81 units on a scale | Standard Deviation 4.33 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Extension Follow-up Month 24 | 0.97 units on a scale | Standard Deviation 4.36 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Cycle 3 Day 1 | 0.78 units on a scale | Standard Deviation 3.14 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 14 | 1.07 units on a scale | Standard Deviation 3.82 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Cycle 4 Day 1 | 3.40 units on a scale | Standard Deviation 4.42 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 24 | 1.12 units on a scale | Standard Deviation 3.78 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Cycle 5 Day 1 | 0.50 units on a scale | Standard Deviation 3.52 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 16 | 1.04 units on a scale | Standard Deviation 3.69 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at End of Induction Treatment | 0.59 units on a scale | Standard Deviation 4.03 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Final Follow-up | 0.34 units on a scale | Standard Deviation 4.37 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 2 | 0.67 units on a scale | Standard Deviation 3.83 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 18 | 1.00 units on a scale | Standard Deviation 3.38 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 4 | 0.95 units on a scale | Standard Deviation 3.51 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Extension Follow-up Month 18 | 0.75 units on a scale | Standard Deviation 3.85 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 6 | 0.96 units on a scale | Standard Deviation 3.44 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 20 | 0.94 units on a scale | Standard Deviation 4.28 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 8 | 0.97 units on a scale | Standard Deviation 3.34 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Extension Follow-up Month 6 | 0.39 units on a scale | Standard Deviation 3.99 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Emotional Well-Being Sub-scale Score | CFB at Follow-up Month 10 | 1.32 units on a scale | Standard Deviation 3.23 |
Secondary
CFB in FACT-Lym-Functional Well-Being Sub-scale Score
The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and n signified those participants who were evaluable for a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | Baseline | 17.98 units on a scale | Standard Deviation 6.31 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Cycle 3 Day 1 | -0.54 units on a scale | Standard Deviation 4.65 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Cycle 4 Day 1 | -0.80 units on a scale | Standard Deviation 2.28 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Cycle 5 Day 1 | -0.71 units on a scale | Standard Deviation 5.04 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at End of Induction Treatment | -0.50 units on a scale | Standard Deviation 5.5 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 2 | 0.31 units on a scale | Standard Deviation 5.27 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 4 | 0.24 units on a scale | Standard Deviation 5.11 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 6 | 0.95 units on a scale | Standard Deviation 4.58 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 8 | -0.27 units on a scale | Standard Deviation 4.38 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 10 | 1.09 units on a scale | Standard Deviation 4.25 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 12 | 0.18 units on a scale | Standard Deviation 5.59 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 14 | 1.16 units on a scale | Standard Deviation 4.27 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 16 | 0.91 units on a scale | Standard Deviation 3.97 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 18 | 0.21 units on a scale | Standard Deviation 4.12 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 20 | -0.27 units on a scale | Standard Deviation 4.9 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 22 | -0.32 units on a scale | Standard Deviation 5.7 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 24 | -0.96 units on a scale | Standard Deviation 4.36 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Final Follow-up | -0.08 units on a scale | Standard Deviation 4.94 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Extension Follow-up Month 6 | 1.01 units on a scale | Standard Deviation 3.51 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Extension Follow-up Month 18 | 0.96 units on a scale | Standard Deviation 4.51 |
| Bendamustine Alone | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Extension Follow-up Month 24 | 2.22 units on a scale | Standard Deviation 3.34 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 12 | 1.78 units on a scale | Standard Deviation 6.04 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | Baseline | 17.90 units on a scale | Standard Deviation 6.08 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Extension Follow-up Month 6 | 0.85 units on a scale | Standard Deviation 6.65 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Cycle 3 Day 1 | 0.38 units on a scale | Standard Deviation 4.66 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 14 | 1.22 units on a scale | Standard Deviation 4.84 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Cycle 4 Day 1 | 1.78 units on a scale | Standard Deviation 4.91 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 24 | 0.98 units on a scale | Standard Deviation 5.87 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Cycle 5 Day 1 | 0.67 units on a scale | Standard Deviation 5.35 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 16 | 1.69 units on a scale | Standard Deviation 5.95 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at End of Induction Treatment | 0.00 units on a scale | Standard Deviation 5.25 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Extension Follow-up Month 24 | 2.62 units on a scale | Standard Deviation 6.95 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 2 | 0.65 units on a scale | Standard Deviation 5.38 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 18 | 1.84 units on a scale | Standard Deviation 5.77 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 4 | 1.31 units on a scale | Standard Deviation 5.86 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Final Follow-up | 0.50 units on a scale | Standard Deviation 6.19 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 6 | 1.26 units on a scale | Standard Deviation 5.08 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 20 | 1.43 units on a scale | Standard Deviation 6.14 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 8 | 0.92 units on a scale | Standard Deviation 5.45 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Extension Follow-up Month 18 | 1.90 units on a scale | Standard Deviation 6.5 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 10 | 1.00 units on a scale | Standard Deviation 5.52 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Functional Well-Being Sub-scale Score | CFB at Follow-up Month 22 | 0.82 units on a scale | Standard Deviation 5 |
Secondary
CFB in FACT-Lym-Lymphoma Sub-scale Score
The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | Baseline | 44.79 units on a scale | Standard Deviation 9.66 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Cycle 3 Day 1 | 0.98 units on a scale | Standard Deviation 6.97 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Cycle 4 Day 1 | -2.80 units on a scale | Standard Deviation 5.76 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Cycle 5 Day 1 | 0.75 units on a scale | Standard Deviation 6.79 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at End of Induction Treatment | 1.64 units on a scale | Standard Deviation 7.1 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 2 | 3.44 units on a scale | Standard Deviation 6.78 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 4 | 2.77 units on a scale | Standard Deviation 6.71 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 6 | 2.33 units on a scale | Standard Deviation 6.44 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 8 | 1.79 units on a scale | Standard Deviation 6.01 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 10 | 1.90 units on a scale | Standard Deviation 6.78 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 12 | 2.12 units on a scale | Standard Deviation 6.47 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 14 | 0.48 units on a scale | Standard Deviation 6.64 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 16 | 0.44 units on a scale | Standard Deviation 7.79 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 18 | 1.18 units on a scale | Standard Deviation 6.09 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 20 | 0.57 units on a scale | Standard Deviation 7.43 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 22 | 1.89 units on a scale | Standard Deviation 8.62 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 24 | 0.66 units on a scale | Standard Deviation 7.59 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Final Follow-up | 1.62 units on a scale | Standard Deviation 7.17 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Extension Follow-up Month 6 | 0.92 units on a scale | Standard Deviation 5.06 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Extension Follow-up Month 18 | 1.80 units on a scale | Standard Deviation 8.3 |
| Bendamustine Alone | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Extension Follow-up Month 24 | 4.89 units on a scale | Standard Deviation 6.67 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 12 | 2.89 units on a scale | Standard Deviation 6.42 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | Baseline | 45.61 units on a scale | Standard Deviation 9.17 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Extension Follow-up Month 6 | 2.98 units on a scale | Standard Deviation 7.22 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Cycle 3 Day 1 | 1.24 units on a scale | Standard Deviation 5.71 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 14 | 2.58 units on a scale | Standard Deviation 6.37 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Cycle 4 Day 1 | 9.50 units on a scale | Standard Deviation 3.54 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 24 | 2.73 units on a scale | Standard Deviation 6.48 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Cycle 5 Day 1 | 1.41 units on a scale | Standard Deviation 6.21 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 16 | 3.27 units on a scale | Standard Deviation 6.14 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at End of Induction Treatment | 0.74 units on a scale | Standard Deviation 7.89 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Extension Follow-up Month 24 | 2.23 units on a scale | Standard Deviation 6.85 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 2 | 2.45 units on a scale | Standard Deviation 6.22 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 18 | 2.91 units on a scale | Standard Deviation 6.79 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 4 | 2.39 units on a scale | Standard Deviation 6.54 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Final Follow-up | 1.33 units on a scale | Standard Deviation 7.38 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 6 | 3.00 units on a scale | Standard Deviation 7.05 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 20 | 2.83 units on a scale | Standard Deviation 6.41 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 8 | 2.52 units on a scale | Standard Deviation 6.69 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Extension Follow-up Month 18 | 2.35 units on a scale | Standard Deviation 5.72 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 10 | 2.28 units on a scale | Standard Deviation 6.82 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Lymphoma Sub-scale Score | CFB at Follow-up Month 22 | 2.55 units on a scale | Standard Deviation 6.58 |
Secondary
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score
The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and n signified those participants who were evaluable for a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 12 | 0.06 units on a scale | Standard Deviation 5.89 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 2 | -0.02 units on a scale | Standard Deviation 4.83 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 14 | 0.56 units on a scale | Standard Deviation 3.28 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | Baseline | 22.04 units on a scale | Standard Deviation 5.65 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 16 | 0.36 units on a scale | Standard Deviation 6.79 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 4 | 0.27 units on a scale | Standard Deviation 4.65 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 18 | 0.44 units on a scale | Standard Deviation 6.23 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Cycle 5 Day 1 | -0.34 units on a scale | Standard Deviation 4.32 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 20 | -0.66 units on a scale | Standard Deviation 4.28 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 6 | 0.05 units on a scale | Standard Deviation 4.46 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 22 | 0.29 units on a scale | Standard Deviation 7.12 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Cycle 3 Day 1 | -0.21 units on a scale | Standard Deviation 3.59 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 24 | -1.29 units on a scale | Standard Deviation 3.91 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 8 | -0.68 units on a scale | Standard Deviation 3.67 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Final Follow-up | -0.19 units on a scale | Standard Deviation 4.91 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at End of Induction Treatment | -0.65 units on a scale | Standard Deviation 5.21 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Extension Follow-up Month 6 | -0.35 units on a scale | Standard Deviation 2.49 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Extension Follow-up Month 18 | -0.15 units on a scale | Standard Deviation 2.92 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 10 | 0.56 units on a scale | Standard Deviation 5 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Extension Follow-up Month 24 | -0.41 units on a scale | Standard Deviation 3.18 |
| Bendamustine Alone | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Cycle 4 Day 1 | -1.00 units on a scale | Standard Deviation 3.67 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Extension Follow-up Month 24 | 0.44 units on a scale | Standard Deviation 5.02 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Cycle 3 Day 1 | -0.10 units on a scale | Standard Deviation 3.87 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | Baseline | 22.14 units on a scale | Standard Deviation 5.51 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Cycle 4 Day 1 | 3.11 units on a scale | Standard Deviation 2.83 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Cycle 5 Day 1 | -0.34 units on a scale | Standard Deviation 4.33 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at End of Induction Treatment | -0.88 units on a scale | Standard Deviation 3.6 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 2 | -0.57 units on a scale | Standard Deviation 5.37 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 4 | -0.26 units on a scale | Standard Deviation 5.02 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 6 | -0.08 units on a scale | Standard Deviation 4.64 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 8 | -0.37 units on a scale | Standard Deviation 4.99 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 10 | 0.13 units on a scale | Standard Deviation 5.14 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 12 | -0.47 units on a scale | Standard Deviation 5.64 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 14 | -0.03 units on a scale | Standard Deviation 4.16 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 16 | -0.15 units on a scale | Standard Deviation 5.28 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 18 | 0.04 units on a scale | Standard Deviation 5.35 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 20 | 0.00 units on a scale | Standard Deviation 5.75 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 22 | -0.50 units on a scale | Standard Deviation 5.02 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Follow-up Month 24 | -0.41 units on a scale | Standard Deviation 5.24 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Final Follow-up | -0.52 units on a scale | Standard Deviation 5.56 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Extension Follow-up Month 18 | 0.71 units on a scale | Standard Deviation 5.26 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym-Social/Family Well-being Sub-scale Score | CFB at Extension Follow-up Month 6 | -0.16 units on a scale | Standard Deviation 4.92 |
Secondary
CFB in FACT-Lym Total Score
FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Follow-up Month 2 | 5.10 Units on a scale | Standard Deviation 17.73 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | Baseline | 124.56 Units on a scale | Standard Deviation 24.17 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Cycle 3 Day 1 | -0.74 Units on a scale | Standard Deviation 17.91 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Cycle 4 Day 1 | -12.16 Units on a scale | Standard Deviation 14.8 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Cycle 5 Day 1 | -1.68 Units on a scale | Standard Deviation 16.61 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at End of Induction Treatment | 0.02 Units on a scale | Standard Deviation 18.55 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Follow-up Month 4 | 5.40 Units on a scale | Standard Deviation 16.29 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Follow-up Month 6 | 5.03 Units on a scale | Standard Deviation 15.01 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Follow-up Month 8 | 1.48 Units on a scale | Standard Deviation 14.27 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Follow-up Month 10 | 4.58 Units on a scale | Standard Deviation 16.39 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Follow-up Month 12 | 2.97 Units on a scale | Standard Deviation 17.84 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Follow-up Month 14 | 3.18 Units on a scale | Standard Deviation 13.85 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Follow-up Month 16 | 2.25 Units on a scale | Standard Deviation 14.98 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Follow-up Month 18 | 2.16 Units on a scale | Standard Deviation 15.38 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Follow-up Month 20 | -0.89 Units on a scale | Standard Deviation 16.34 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Follow-up Month 22 | 2.15 Units on a scale | Standard Deviation 19.03 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Follow-up Month 24 | -2.13 Units on a scale | Standard Deviation 15.74 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Final follow-up | 2.15 Units on a scale | Standard Deviation 16.6 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Extension Follow Up Month 6 | 1.22 Units on a scale | Standard Deviation 11.67 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Extension Follow Up Month 18 | 4.92 Units on a scale | Standard Deviation 14.73 |
| Bendamustine Alone | CFB in FACT-Lym Total Score | CFB at Extension Follow Up Month 24 | 9.69 Units on a scale | Standard Deviation 15.88 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Follow-up Month 12 | 5.88 Units on a scale | Standard Deviation 18.93 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Extension Follow Up Month 6 | 5.14 Units on a scale | Standard Deviation 20.3 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | Baseline | 126.22 Units on a scale | Standard Deviation 23.98 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Follow-up Month 14 | 5.92 Units on a scale | Standard Deviation 17.06 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Cycle 3 Day 1 | 1.33 Units on a scale | Standard Deviation 13.89 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Follow-up Month 24 | 5.28 Units on a scale | Standard Deviation 18.75 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Cycle 4 Day 1 | 22.53 Units on a scale | Standard Deviation 16.23 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Follow-up Month 16 | 7.59 Units on a scale | Standard Deviation 16.97 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Extension Follow Up Month 24 | 6.13 Units on a scale | Standard Deviation 20.32 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at End of Induction Treatment | 0.35 Units on a scale | Standard Deviation 18.29 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Cycle 5 Day 1 | 1.71 Units on a scale | Standard Deviation 15.23 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Follow-up Month 2 | 3.54 Units on a scale | Standard Deviation 15.45 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Follow-up Month 18 | 6.99 Units on a scale | Standard Deviation 18.27 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Follow-up Month 4 | 5.50 Units on a scale | Standard Deviation 17.76 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Final follow-up | 2.55 Units on a scale | Standard Deviation 20.11 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Follow-up Month 6 | 6.57 Units on a scale | Standard Deviation 15.96 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Follow-up Month 20 | 5.66 Units on a scale | Standard Deviation 18.9 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Follow-up Month 8 | 5.18 Units on a scale | Standard Deviation 15.61 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Extension Follow Up Month 18 | 6.88 Units on a scale | Standard Deviation 19.24 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Follow-up Month 10 | 5.70 Units on a scale | Standard Deviation 16.89 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Total Score | CFB at Follow-up Month 22 | 4.59 Units on a scale | Standard Deviation 17.98 |
Secondary
CFB in FACT-Lym Trial Outcome Index (TOI)
TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 12 | 2.05 Units on a scale | Standard Deviation 15.14 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 2 | 3.75 Units on a scale | Standard Deviation 15.36 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 14 | 2.25 Units on a scale | Standard Deviation 11.92 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Cycle 3 Day 1 | -1.94 Units on a scale | Standard Deviation 17.96 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 16 | 0.75 Units on a scale | Standard Deviation 14.15 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 4 | 3.81 Units on a scale | Standard Deviation 13.39 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 18 | 1.36 Units on a scale | Standard Deviation 11.3 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Cycle 5 Day 1 | -1.38 Units on a scale | Standard Deviation 15.38 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 20 | -0.64 Units on a scale | Standard Deviation 15.21 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 6 | 3.26 Units on a scale | Standard Deviation 12.19 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 22 | 2.26 Units on a scale | Standard Deviation 14.54 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | Baseline | 84.66 Units on a scale | Standard Deviation 19.36 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 24 | -0.14 Units on a scale | Standard Deviation 13.44 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 8 | 1.36 Units on a scale | Standard Deviation 12.39 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Final Follow-up | 0.84 Units on a scale | Standard Deviation 14.8 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at End of Induction Treatment | -0.52 Units on a scale | Standard Deviation 17.23 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Extension Follow Up Month 6 | 2.30 Units on a scale | Standard Deviation 10.77 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Extension Follow Up Month 18 | 4.02 Units on a scale | Standard Deviation 14.01 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 10 | 3.52 Units on a scale | Standard Deviation 13.16 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Extension Follow Up Month 24 | 10.04 Units on a scale | Standard Deviation 13.35 |
| Bendamustine Alone | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Cycle 4 Day 1 | -10.40 Units on a scale | Standard Deviation 10.38 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Extension Follow Up Month 24 | 7.07 Units on a scale | Standard Deviation 17.59 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | Baseline | 84.76 Units on a scale | Standard Deviation 18.97 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Cycle 3 Day 1 | 1.81 Units on a scale | Standard Deviation 13.88 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Cycle 4 Day 1 | 26.44 Units on a scale | Standard Deviation 19.51 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Cycle 5 Day 1 | 2.37 Units on a scale | Standard Deviation 14.15 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at End of Induction Treatment | 0.40 Units on a scale | Standard Deviation 16.45 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 2 | 4.60 Units on a scale | Standard Deviation 14.85 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 4 | 5.18 Units on a scale | Standard Deviation 17.06 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 6 | 6.07 Units on a scale | Standard Deviation 13.72 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 8 | 5.36 Units on a scale | Standard Deviation 14.21 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 10 | 4.94 Units on a scale | Standard Deviation 15.96 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 12 | 6.13 Units on a scale | Standard Deviation 15.72 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 14 | 5.13 Units on a scale | Standard Deviation 14.3 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 16 | 6.78 Units on a scale | Standard Deviation 15.11 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 18 | 7.26 Units on a scale | Standard Deviation 14.62 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 20 | 6.36 Units on a scale | Standard Deviation 14.99 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 22 | 5.30 Units on a scale | Standard Deviation 17.88 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Follow-up Month 24 | 5.30 Units on a scale | Standard Deviation 17.88 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Final Follow-up | 3.84 Units on a scale | Standard Deviation 16.22 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Extension Follow Up Month 18 | 7.31 Units on a scale | Standard Deviation 15.69 |
| Obinutuzumab + Bendamustine | CFB in FACT-Lym Trial Outcome Index (TOI) | CFB at Extension Follow Up Month 6 | 5.53 Units on a scale | Standard Deviation 18.44 |
Secondary
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score
The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and n signified those participants who were evaluable for a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 2 | 1.53 Units on a scale | Standard Deviation 13.42 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 14 | 2.48 Units on a scale | Standard Deviation 9.42 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | Baseline | 79.86 Units on a scale | Standard Deviation 16.25 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 16 | 1.54 Units on a scale | Standard Deviation 10.61 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 4 | 2.55 Units on a scale | Standard Deviation 11.47 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 18 | 1.16 Units on a scale | Standard Deviation 11.57 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Cycle 5 Day 1 | -2.44 Units on a scale | Standard Deviation 12.01 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 20 | -1.21 Units on a scale | Standard Deviation 12.25 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 6 | 2.54 Units on a scale | Standard Deviation 10.68 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 22 | 0.64 Units on a scale | Standard Deviation 14.27 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Cycle 3 Day 1 | -1.87 Units on a scale | Standard Deviation 12.28 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 24 | -2.39 Units on a scale | Standard Deviation 9.32 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 8 | -0.53 Units on a scale | Standard Deviation 10.15 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Final Follow-up | 0.50 Units on a scale | Standard Deviation 11.25 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at End of Induction Treatment | -1.84 Units on a scale | Standard Deviation 13.83 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Extension Follow Up Month 6 | 0.48 Units on a scale | Standard Deviation 8.71 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 10 | 2.29 Units on a scale | Standard Deviation 11.39 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Extension Follow Up Month 18 | 2.29 Units on a scale | Standard Deviation 8.4 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Cycle 4 Day 1 | -9.37 Units on a scale | Standard Deviation 9.89 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Extension Follow Up Month 24 | 4.48 Units on a scale | Standard Deviation 11.1 |
| Bendamustine Alone | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 12 | 0.68 Units on a scale | Standard Deviation 13.16 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Extension Follow Up Month 24 | 4.47 Units on a scale | Standard Deviation 15.22 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Cycle 3 Day 1 | 0.11 Units on a scale | Standard Deviation 10.3 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Cycle 4 Day 1 | 0.52 Units on a scale | Standard Deviation 4.98 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Cycle 5 Day 1 | 0.06 Units on a scale | Standard Deviation 11.13 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at End of Induction Treatment | -0.92 Units on a scale | Standard Deviation 11.77 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 2 | 1.22 Units on a scale | Standard Deviation 12.01 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 4 | 3.06 Units on a scale | Standard Deviation 13 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 6 | 3.24 Units on a scale | Standard Deviation 11.4 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 8 | 2.49 Units on a scale | Standard Deviation 11.45 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 10 | 3.46 Units on a scale | Standard Deviation 11.83 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 12 | 2.82 Units on a scale | Standard Deviation 14.29 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 14 | 2.94 Units on a scale | Standard Deviation 11.97 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 16 | 4.09 Units on a scale | Standard Deviation 12.87 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 18 | 4.06 Units on a scale | Standard Deviation 13.36 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 20 | 3.05 Units on a scale | Standard Deviation 14.29 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 22 | 1.80 Units on a scale | Standard Deviation 12.43 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Follow-up Month 24 | 2.28 Units on a scale | Standard Deviation 13.83 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Final Follow-up | 0.78 Units on a scale | Standard Deviation 14.94 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Extension Follow Up Month 6 | 1.74 Units on a scale | Standard Deviation 14.23 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | CFB at Extension Follow Up Month 18 | 4.56 Units on a scale | Standard Deviation 15.02 |
| Obinutuzumab + Bendamustine | CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score | Baseline | 80.78 Units on a scale | Standard Deviation 16.27 |
Secondary
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score
The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-168. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (QoL). In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time frame: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24
Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and n signified those participants who were evaluable for a specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | Baseline | 22.58 units on a scale | Standard Deviation 5.23 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Cycle 3 Day 1 | -1.56 units on a scale | Standard Deviation 5.49 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Cycle 4 Day 1 | -6.80 units on a scale | Standard Deviation 4.21 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Cycle 5 Day 1 | -1.82 units on a scale | Standard Deviation 5.06 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at End of Induction Treatment | -1.00 units on a scale | Standard Deviation 5.14 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 2 | 0.62 units on a scale | Standard Deviation 5.14 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 4 | 0.53 units on a scale | Standard Deviation 4.58 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 6 | 0.29 units on a scale | Standard Deviation 3.74 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 8 | -0.01 units on a scale | Standard Deviation 3.53 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 10 | 0.06 units on a scale | Standard Deviation 4.16 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 12 | 0.26 units on a scale | Standard Deviation 4.02 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 14 | 0.03 units on a scale | Standard Deviation 4.14 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 16 | -0.10 units on a scale | Standard Deviation 3.49 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 18 | -0.22 units on a scale | Standard Deviation 3.64 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 20 | -0.36 units on a scale | Standard Deviation 3.7 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 22 | -0.25 units on a scale | Standard Deviation 3.93 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 24 | -0.77 units on a scale | Standard Deviation 4.16 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Final Follow-up | 0.16 units on a scale | Standard Deviation 4.17 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Extension Follow-up Month 6 | 0.36 units on a scale | Standard Deviation 3.48 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Extension Follow-up Month 18 | 0.80 units on a scale | Standard Deviation 2.54 |
| Bendamustine Alone | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Extension Follow-up Month 24 | 1.53 units on a scale | Standard Deviation 5.96 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 12 | 0.74 units on a scale | Standard Deviation 4.24 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | Baseline | 22.76 units on a scale | Standard Deviation 4.61 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Extension Follow-up Month 6 | 0.57 units on a scale | Standard Deviation 4.71 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Cycle 3 Day 1 | -0.69 units on a scale | Standard Deviation 4.06 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 14 | 0.71 units on a scale | Standard Deviation 3.94 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Cycle 4 Day 1 | -3.00 units on a scale | Standard Deviation 2.83 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 24 | 0.52 units on a scale | Standard Deviation 4.42 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Cycle 5 Day 1 | -0.72 units on a scale | Standard Deviation 4.16 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 16 | 1.31 units on a scale | Standard Deviation 3.68 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at End of Induction Treatment | -0.61 units on a scale | Standard Deviation 4.62 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Extension Follow-up Month 24 | 0.56 units on a scale | Standard Deviation 5.26 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 2 | 0.58 units on a scale | Standard Deviation 4.45 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 18 | 0.92 units on a scale | Standard Deviation 3.99 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 4 | 0.88 units on a scale | Standard Deviation 4.47 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Final Follow-up | 0.22 units on a scale | Standard Deviation 4.47 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 6 | 0.91 units on a scale | Standard Deviation 3.82 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 20 | 0.74 units on a scale | Standard Deviation 3.69 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 8 | 0.87 units on a scale | Standard Deviation 3.96 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Extension Follow-up Month 18 | 1.19 units on a scale | Standard Deviation 4.98 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 10 | 0.56 units on a scale | Standard Deviation 3.81 |
| Obinutuzumab + Bendamustine | Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score | CFB at Follow-up Month 22 | 0.40 units on a scale | Standard Deviation 4.47 |
Secondary
Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator
DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL \[Modified Cheson et al, 2007\]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method.
Time frame: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
Population: ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine Alone | Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator | 20.0 months |
| Obinutuzumab + Bendamustine | Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator | 36.0 months |
95% CI: [0.29, 0.81]
Secondary
Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC
DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL \[Modified Cheson et al, 2007\]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015.
Time frame: Baseline until PD or death, whichever occurred first (up to approximately 5 years)
Population: ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine Alone | Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC | 13.2 months |
| Obinutuzumab + Bendamustine | Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC | NA months |
95% CI: [0.04, 0.45]
Secondary
Duration of Response (DoR) as Assessed by Investigator
DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy; liver, spleen returned to normal size (if enlarged at baseline); if bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic, hepatic nodules; involvement of other organs is usually assessable; no presence of measurable disease. PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR was estimated using Kaplan-Meier method.
Time frame: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
Population: ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine Alone | Duration of Response (DoR) as Assessed by Investigator | 12.7 months |
| Obinutuzumab + Bendamustine | Duration of Response (DoR) as Assessed by Investigator | 32.3 months |
95% CI: [0.39, 0.67]
Secondary
Duration of Response (DoR) as Assessed by IRC
DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable evidence of disease & disease-related symptoms if present before therapy; liver, spleen returned to normal size; if bone marrow involved by lymphoma before treatment, infiltrate must be cleared on repeat bone marrow biopsy. PR: at least 50% measurable disease regressed vs. to baseline scan and no new sites; no increase in size of other nodes/liver/spleen, exception: splenic, hepatic nodules; other organs involved is usually assessable; no measurable disease present. PD: any new lesion \>1.5 cm in any axis appear during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR estimated using Kaplan-Meier method. IRC review performed up to clinical cutoff date 1 May 2015.
Time frame: Baseline until PD or death, whichever occurred first (up to approximately 5 years)
Population: ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine Alone | Duration of Response (DoR) as Assessed by IRC | 12.7 months |
| Obinutuzumab + Bendamustine | Duration of Response (DoR) as Assessed by IRC | 38.5 months |
95% CI: [0.31, 0.61]
Secondary
Event-free Survival (EFS) as Assessed by IRC
EFS was defined as the time between the date of randomization and the date of PD/relapse based on IRC assessments (as per modified response criteria for iNHL \[Modified Cheson et al, 2007\]), death from any cause on study, or start of a new anti-lymphoma therapy. PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. EFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015.
Time frame: Baseline until PD or death, whichever occurred first (up to approximately 5 years)
Population: ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine Alone | Event-free Survival (EFS) as Assessed by IRC | 13.7 months |
| Obinutuzumab + Bendamustine | Event-free Survival (EFS) as Assessed by IRC | 25.3 months |
p-value: 0.000195% CI: [0.44, 0.74]Log Rank
Secondary
Number of Participants With PD or Death as Assessed by Investigator
PD was assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of \<1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node \>1 cm in its short axis.
Time frame: Baseline until PD or death, whichever occurred first (up to 8.5 years overall))
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine Alone | Number of Participants With PD or Death as Assessed by Investigator | 152 participants |
| Obinutuzumab + Bendamustine | Number of Participants With PD or Death as Assessed by Investigator | 132 participants |
Secondary
Overall Survival (OS)
OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time frame: Baseline until death (up to 8.5 years overall)
Population: ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine Alone | Overall Survival (OS) | 65.6 months |
| Obinutuzumab + Bendamustine | Overall Survival (OS) | 88.3 months |
p-value: 0.08195% CI: [0.57, 1.03]Log Rank
Secondary
Percentage of Participants Who Died
Time frame: Baseline until death (up to 8.5 years overall)
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine Alone | Percentage of Participants Who Died | 49.3 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants Who Died | 41.2 percentage of participants |
Secondary
Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator
BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).
Time frame: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
Population: ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bendamustine Alone | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | CR | 21.5 percentage of participants |
| Bendamustine Alone | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | PR | 61.7 percentage of participants |
| Bendamustine Alone | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | SD | 6.7 percentage of participants |
| Bendamustine Alone | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | PD | 4.8 percentage of participants |
| Bendamustine Alone | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | Unable to evaluate | 1.4 percentage of participants |
| Bendamustine Alone | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | Missing | 3.8 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | Unable to evaluate | 0.5 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | CR | 23.5 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | PD | 6.4 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | PR | 58.8 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | Missing | 4.4 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator | SD | 6.4 percentage of participants |
Secondary
Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC
BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan & no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions (e.g., splenic or hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015.
Time frame: Baseline until PD or death, whichever occurred first (up to approximately 5 years)
Population: ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bendamustine Alone | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | CR | 17.2 percentage of participants |
| Bendamustine Alone | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | PR | 60.3 percentage of participants |
| Bendamustine Alone | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | SD | 12.0 percentage of participants |
| Bendamustine Alone | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | PD | 5.7 percentage of participants |
| Bendamustine Alone | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | Unable to evaluate | 1.0 percentage of participants |
| Bendamustine Alone | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | Missing | 3.8 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | Unable to evaluate | 1.0 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | CR | 16.2 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | PD | 4.9 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | PR | 59.3 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | Missing | 4.9 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC | SD | 13.7 percentage of participants |
Secondary
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator
BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).
Time frame: Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)
Population: ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bendamustine Alone | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | CR | 15.8 percentage of participants |
| Bendamustine Alone | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | PR | 53.1 percentage of participants |
| Bendamustine Alone | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | SD | 4.3 percentage of participants |
| Bendamustine Alone | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | PD | 12.0 percentage of participants |
| Bendamustine Alone | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | Unable to Evaluate | 2.9 percentage of participants |
| Bendamustine Alone | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | Missing | 12.0 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | Unable to Evaluate | 0.5 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | CR | 17.2 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | PD | 9.3 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | PR | 60.3 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | Missing | 8.8 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator | SD | 3.9 percentage of participants |
Secondary
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC
BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan & no new sites; no increase in size of other nodes, liver or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or size of other lesions (e.g., splenic/hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015.
Time frame: Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)
Population: ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bendamustine Alone | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | CR | 12.0 percentage of participants |
| Bendamustine Alone | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | PR | 52.4 percentage of participants |
| Bendamustine Alone | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | SD | 10.1 percentage of participants |
| Bendamustine Alone | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | PD | 10.6 percentage of participants |
| Bendamustine Alone | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | Unable to Evaluate | 2.9 percentage of participants |
| Bendamustine Alone | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | Missing | 12.0 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | Unable to Evaluate | 2.0 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | CR | 11.8 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | PD | 8.8 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | PR | 54.9 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | Missing | 10.8 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC | SD | 11.8 percentage of participants |
Secondary
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores
FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0-116). FACT-Lym total score is sum of 42 items (total score ranges from 0-168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6).
Time frame: Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), 12 (FUM12), 18 (FUM18), 24 (FUM24), Extension Follow Up Month 6 (Extension FUM6)
Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | C5D1 (>=3 pt increase) | 30.3 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM6 (>=3 pt increase) | 37.9 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM12 (>=3 pt increase) | 36.7 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM18 (>=3 pt increase) | 35.6 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM24 (>=3 pt increase) | 35.3 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | Ext FUM6 (>=3 pt increase) | 36.0 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | C5D1 (>=6 pt increase) | 23.1 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM6 (>=6 pt increase) | 29.5 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM12 (>=6 pt increase) | 26.2 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM18 (>=6 pt increase) | 28.9 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM24 (>=6 pt increase) | 26.5 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | Ext FUM6 (>=6 pt increase) | 44 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | C5D1 (>=7 pt increase) | 24.4 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM6 (>=7 pt increase) | 34.1 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM12 (>=7 pt increase) | 31.1 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM18 (>=7 pt increase) | 31.1 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM24 (>=7 pt increase) | 20.6 Percentage of participants |
| Bendamustine Alone | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | Ext FUM6 (>=7 pt increase) | 32 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM6 (>=7 pt increase) | 40.3 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | C5D1 (>=3 pt increase) | 41.7 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM18 (>=6 pt increase) | 51.8 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM6 (>=3 pt increase) | 47.1 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | Ext FUM6 (>=7 pt increase) | 47.7 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM12 (>=3 pt increase) | 46.5 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM24 (>=6 pt increase) | 48.0 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM18 (>=3 pt increase) | 53.0 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM12 (>=7 pt increase) | 45.0 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM24 (>=3 pt increase) | 50 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | Ext FUM6 (>=6 pt increase) | 56.9 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | Ext FUM6 (>=3 pt increase) | 57.8 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM24 (>=7 pt increase) | 42.7 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | C5D1 (>=6 pt increase) | 34.4 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | C5D1 (>=7 pt increase) | 28.0 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM6 (>=6 pt increase) | 43.7 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM18 (>=7 pt increase) | 43.4 Percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores | FUM12 (>=6 pt increase) | 47.0 Percentage of participants |
Secondary
Percentage of Participants With Objective Response as Assessed by Investigator
Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.
Time frame: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
Population: ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine Alone | Percentage of Participants With Objective Response as Assessed by Investigator | 83.3 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Objective Response as Assessed by Investigator | 82.4 percentage of participants |
p-value: 0.785795% CI: [-8.44, 6.64]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Objective Response as Assessed by IRC
Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015.
Time frame: Baseline until PD or death, whichever occurred first (up to approximately 5 years)
Population: ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine Alone | Percentage of Participants With Objective Response as Assessed by IRC | 77.5 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Objective Response as Assessed by IRC | 75.5 percentage of participants |
p-value: 0.929895% CI: [0.58, 1.65]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator
Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.
Time frame: Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)
Population: ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine Alone | Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator | 68.9 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator | 77.5 percentage of participants |
p-value: 0.046695% CI: [-0.22, 17.32]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC
Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015.
Time frame: Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)
Population: ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bendamustine Alone | Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC | 64.4 percentage of participants |
| Obinutuzumab + Bendamustine | Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC | 66.7 percentage of participants |
p-value: 0.834795% CI: [-7.2, 11.69]Cochran-Mantel-Haenszel
Secondary
PFS as Assessed by Investigator
PFS was defined as the time from randomization to the first occurrence of PD as assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007), or death from any cause on study. PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of \<1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node \>1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time frame: Baseline until PD or death, whichever occurred first (up to 8.5 years overall)
Population: ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine Alone | PFS as Assessed by Investigator | 14.1 months |
| Obinutuzumab + Bendamustine | PFS as Assessed by Investigator | 25.8 months |
p-value: <0.000195% CI: [0.45, 0.73]Log Rank
Secondary
Time to Deterioration of FACT-Lym TOI
The median time, in month, from date of randomization until a clinically meaningful decline from baseline in TOI or death, whichever occurred first. TOI: sum of physical well-being score,functional well-being score, and Lymphoma sub-scale of FACT-Lym; total 29 items, responses to each item range from 0, Not at all to 4, Very much. Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from baseline. Time to deterioration was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. In timeframe, follow-up months represents months after end of induction (EOI) (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).
Time frame: Baseline up to approximately 8.5 years
Population: ITT population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bendamustine Alone | Time to Deterioration of FACT-Lym TOI | 5.6 Months |
| Obinutuzumab + Bendamustine | Time to Deterioration of FACT-Lym TOI | 8.0 Months |