Lymphoma
Conditions
Keywords
Lymphoma, B-cell lymphoma, Non-germinal center B-cell subtype, Diffuse large B-cell lymphoma, Bruton's tyrosine kinase inhibitor, PCI-32765, JNJ-54179060, Ibrutinib, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Brief summary
The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene expression profiling (GEP) or both populations.
Detailed description
This is a randomized (individuals assigned to study treatment by chance), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study to compare the efficacy and safety of ibrutinib in combination with R-CHOP versus R-CHOP alone in adult patients newly diagnosed non-GCB DLBCL selected by IHC or newly diagnosed patients with ABC subtype of DLBCL identified by GEP or both populations. The study will include screening, active treatment, and posttreatment follow-up phases. The study will end when 50% of participants have died or 5 years after the last participant is randomized or the sponsor terminates the study, whichever occurs first. Approximately 800 participants will be randomly assigned in a 1:1 ratio to receive either placebo+R-CHOP (treatment arm A) or ibrutinib+R-CHOP (treatment arm B). All participants will receive R-CHOP as background therapy for 6 or 8 cycles (21 days per cycle) prespecified according to local practice. After 4 treatment cycles, an interim response assessment will be performed to evaluate disease progression for each participant. Participants with progressive disease or relapsed disease after complete response will be discontinued from treatment. Participants who discontinue R-CHOP without disease progression will continue study drug (placebo or ibrutinib) until 6 or 8 cycles are completed, disease progression, or unacceptable toxicity, whichever occurs first. After completion of study drug, participants will undergo assessment of tumor response based on the Revised Response Criteria for Malignant Lymphoma. Participants with documented residual disease upon completion of at least 6 cycles of R-CHOP therapy are considered eligible to initiate subsequent antilymphoma therapy. Serial pharmacokinetic samples will be collected before and after dosing, and safety will be monitored throughout the study.
Interventions
DRUGIbrutinib
560 mg capsules administered by mouth once daily (21-day cycles)
DRUGPlacebo
4 matched capsules administered by mouth once daily (21-day cycles)
DRUGRituximab
375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
DRUGCyclophosphamide
750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
DRUGDoxorubicin
50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
DRUGVincristine
1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle
Sponsors
Pharmacyclics LLC.
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* No prior treatment for diffuse B-cell lymphoma (DLBCL) * Histologically-confirmed non-germinal center B-cell subtype DLBCL * Stage II (not candidates for local x-ray therapy), III, or IV disease by the Ann Arbor Classification * At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma * Revised International Prognostic Index score of \>=1 * Eastern Cooperative Oncology Group performance status grade of 0, 1, or 2 * Hematology and biochemical laboratory values within protocol-defined parameters prior to random assignment and at baseline * Left ventricular ejection fraction within institutional normal limits, as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan * Agrees to protocol-defined use of effective contraception (for women, these restrictions apply for 12 months after the last dose of rituximab or 1 month after the last dose of study drug, whichever is later; for men, these restrictions apply for 12 months after the last dose of rituximab or 3 months after the last dose of study drug, whichever is later) * Men must agree to not donate sperm during and after the study for 12 months after the last dose of rituximab or 3 months after the last dose of study drug, whichever is later * Women of childbearing potential must have a negative serum or urine pregnancy test at screening
Exclusion criteria
* Major surgery within 4 weeks of random assignment * Known central nervous system or primary mediastinal lymphoma * Prior history of indolent lymphoma * Diagnosed or treated for malignancy other than DLBCL, except: malignancy treated with curative intent and with no known active disease present for \>=3 years before random assignment; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease * History of stroke or intracranial hemorrhage within 6 months prior to random assignment * Requires anticoagulation with warfarin or equivalent vitamin K antagonists * Requires treatment with strong CYP3A inhibitors * Prior anthracycline use \>=150 mg/m2 * Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification * Known history of human immunodeficiency virus or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antibiotics * Women who are pregnant or breastfeeding * Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population | Up to 5.5 years | EFS: duration from randomization date to disease progression(PD) date, relapse from complete response(CR) assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either positron emission tomography(PET)-positive/ biopsy-proven residual disease upon completion of \>=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in sum of product of diameters(SPD) of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. |
| Event-Free Survival (EFS) - Activated B-Cell (ABC) Population | Up to approximately 4.5 years | EFS: duration from randomization date to PD date, relapse from CR assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either PET-positive/ biopsy-proven residual disease upon completion of \>=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to approximately 4.5 years | PFS was defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. Progressive Disease (PD): any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 centimeter (cm) in any axis, 50% increase in SPD of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. |
| Percentage of Participants Who Achieved Complete Response (CR) | Up to approximately 4.5 years | Percentage of participants with measurable disease who achieved CR were reported. CR: disappearance of all evidence of disease. CR Criteria: Complete disappearance of all disease-related symptoms; all lymph nodes and nodal masses regressed to normal size (less than or equal to \[\<=\]1.5 cm in greatest transverse diameter \[GTD\] for nodes greater than \[\>\]1.5 cm before therapy). Previous nodes of 1.1 to 1.5 cm in long axis and greater than (\>)1.0 cm in short axis before treatment decreased to \<=1.0 cm in short axis after treatment. Disappearance of all splenic and hepatic nodules and other extranodal disease; a negative positron emission tomography (PET) scan. A posttreatment residual mass of any size but PET-negative; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy. |
| Overall Survival | Up to 5.5 years | Overall survival was defined as the duration from the date of randomization to the date of the participant's death. Median Overall Survival was estimated by using the Kaplan-Meier method. |
| Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) | Up to approximately 4.5 years | Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life. |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Japan, Mexico, Netherlands, Norway, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm B: Ibrutinib+R-CHOP Participants received ibrutinib 560 milligram (mg) (4\*140 mg) capsules orally once daily (Cycle 1 Day 1 to Day 21 of last cycle; 21-day cycles) along with R-CHOP (Rituximab - Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) as a background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m\^2) intravenously (IV), cyclophosphamide 750 mg/m\^2 IV, doxorubicin 50 mg/m\^2 IV, and vincristine 1.4 mg/m\^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus ibrutinib for 6 or 8 cycles per site preference (21 days per cycle). | 419 |
| Treatment Arm A: Placebo+R-CHOP Participants received matching placebo (4 capsules) orally once daily (21-day cycles) along with R-CHOP background chemotherapy. R-CHOP regimen included rituximab 375 milligram per square meter (mg/m\^2) intravenously (IV), cyclophosphamide 750 mg/m\^2 IV, doxorubicin 50 mg/m\^2 IV, and vincristine 1.4 mg/m\^2 IV, administered on Day 1 and prednisone 100 mg capsules orally on Days 1 to 5 of each cycle. Participants received background chemotherapy plus matching placebo for 6 or 8 cycles per site preference (21 days per cycle). | 419 |
| Total | 838 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 78 | 78 |
| Overall Study | Lost to Follow-up | 9 | 23 |
| Overall Study | Sponsor ends the study | 297 | 290 |
| Overall Study | Withdrawal by Subject | 35 | 28 |
Baseline characteristics
| Characteristic | Treatment Arm A: Placebo+R-CHOP | Treatment Arm B: Ibrutinib+R-CHOP | Total |
|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 13.57 | 61.1 years STANDARD_DEVIATION 12.57 | 59.9 years STANDARD_DEVIATION 13.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 17 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 396 Participants | 388 Participants | 784 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 14 Participants | 24 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 160 Participants | 166 Participants | 326 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not reported | 2 Participants | 7 Participants | 9 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 250 Participants | 237 Participants | 487 Participants |
| Region of Enrollment Argentina | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment Australia | 8 Participants | 12 Participants | 20 Participants |
| Region of Enrollment Belgium | 7 Participants | 8 Participants | 15 Participants |
| Region of Enrollment Brazil | 4 Participants | 8 Participants | 12 Participants |
| Region of Enrollment Canada | 9 Participants | 12 Participants | 21 Participants |
| Region of Enrollment China | 96 Participants | 104 Participants | 200 Participants |
| Region of Enrollment Czech Republic | 12 Participants | 18 Participants | 30 Participants |
| Region of Enrollment Denmark | 6 Participants | 5 Participants | 11 Participants |
| Region of Enrollment Finland | 8 Participants | 6 Participants | 14 Participants |
| Region of Enrollment France | 4 Participants | 7 Participants | 11 Participants |
| Region of Enrollment Germany | 8 Participants | 5 Participants | 13 Participants |
| Region of Enrollment Hungary | 6 Participants | 5 Participants | 11 Participants |
| Region of Enrollment Israel | 12 Participants | 11 Participants | 23 Participants |
| Region of Enrollment Italy | 18 Participants | 24 Participants | 42 Participants |
| Region of Enrollment Japan | 40 Participants | 33 Participants | 73 Participants |
| Region of Enrollment Korea, Republic Of | 11 Participants | 14 Participants | 25 Participants |
| Region of Enrollment Mexico | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment Netherlands | 1 Participants | 5 Participants | 6 Participants |
| Region of Enrollment Norway | 6 Participants | 1 Participants | 7 Participants |
| Region of Enrollment Poland | 24 Participants | 15 Participants | 39 Participants |
| Region of Enrollment Russia | 34 Participants | 19 Participants | 53 Participants |
| Region of Enrollment Spain | 7 Participants | 5 Participants | 12 Participants |
| Region of Enrollment Sweden | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Taiwan, Province Of China | 9 Participants | 8 Participants | 17 Participants |
| Region of Enrollment Turkey | 24 Participants | 27 Participants | 51 Participants |
| Region of Enrollment Ukraine | 9 Participants | 10 Participants | 19 Participants |
| Region of Enrollment United Kingdom | 17 Participants | 14 Participants | 31 Participants |
| Region of Enrollment United States | 36 Participants | 40 Participants | 76 Participants |
| Sex: Female, Male Female | 193 Participants | 198 Participants | 391 Participants |
| Sex: Female, Male Male | 226 Participants | 221 Participants | 447 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 78 / 416 | 78 / 418 |
| other Total, other adverse events | 411 / 416 | 411 / 418 |
| serious Total, serious adverse events | 221 / 416 | 143 / 418 |
Outcome results
Primary
Event-Free Survival (EFS) - Activated B-Cell (ABC) Population
EFS: duration from randomization date to PD date, relapse from CR assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either PET-positive/ biopsy-proven residual disease upon completion of \>=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.
Time frame: Up to approximately 4.5 years
Population: ABC population included ITT population (all randomized participants, enrolled with non-GCB of DLBCL subtype by IHC) having ABC subtype determined by gene expression profiling (GEP) (retrospectively determined from available formalin-fixed paraffin-embedded \[FFPE\] tissue specimens). Participants were analyzed according to randomized treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Arm B: Ibrutinib+R-CHOP | Event-Free Survival (EFS) - Activated B-Cell (ABC) Population | 48.56 Months |
| Treatment Arm A: Placebo+R-CHOP | Event-Free Survival (EFS) - Activated B-Cell (ABC) Population | 48.16 Months |
p-value: 0.731195% CI: [0.704, 1.279]Log Rank
Primary
Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population
EFS: duration from randomization date to disease progression(PD) date, relapse from complete response(CR) assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either positron emission tomography(PET)-positive/ biopsy-proven residual disease upon completion of \>=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in sum of product of diameters(SPD) of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.
Time frame: Up to 5.5 years
Population: Intent-to-Treat (ITT) population included all randomized participants, enrolled with non-germinal center B-cell (GCB) of diffuse large B-cell lymphoma (DLBCL) subtype by immunohistochemistry (IHC), and were analyzed according to treatment to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Arm B: Ibrutinib+R-CHOP | Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population | 49.64 Months |
| Treatment Arm A: Placebo+R-CHOP | Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population | 54.77 Months |
p-value: 0.516795% CI: [0.72, 1.18]Log Rank
Secondary
Overall Survival
Overall survival was defined as the duration from the date of randomization to the date of the participant's death. Median Overall Survival was estimated by using the Kaplan-Meier method.
Time frame: Up to 5.5 years
Population: ITT population included all randomized participants, who were enrolled with the non-GCB of DLBCL subtype by IHC. Participants in this population were analyzed according to the treatment to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Arm B: Ibrutinib+R-CHOP | Overall Survival | NA Months |
| Treatment Arm A: Placebo+R-CHOP | Overall Survival | NA Months |
p-value: 0.854995% CI: [0.754, 1.407]Log Rank
Secondary
Percentage of Participants Who Achieved Complete Response (CR)
Percentage of participants with measurable disease who achieved CR were reported. CR: disappearance of all evidence of disease. CR Criteria: Complete disappearance of all disease-related symptoms; all lymph nodes and nodal masses regressed to normal size (less than or equal to \[\<=\]1.5 cm in greatest transverse diameter \[GTD\] for nodes greater than \[\>\]1.5 cm before therapy). Previous nodes of 1.1 to 1.5 cm in long axis and greater than (\>)1.0 cm in short axis before treatment decreased to \<=1.0 cm in short axis after treatment. Disappearance of all splenic and hepatic nodules and other extranodal disease; a negative positron emission tomography (PET) scan. A posttreatment residual mass of any size but PET-negative; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.
Time frame: Up to approximately 4.5 years
Population: ITT population included all randomized participants, who were enrolled with the non-GCB of DLBCL subtype by IHC. Participants in this population were analyzed according to the treatment to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Arm B: Ibrutinib+R-CHOP | Percentage of Participants Who Achieved Complete Response (CR) | 67.3 Percentage of participants |
| Treatment Arm A: Placebo+R-CHOP | Percentage of Participants Who Achieved Complete Response (CR) | 68.0 Percentage of participants |
p-value: 0.822995% CI: [0.722, 1.296]Cochran-Mantel-Haenszel (CMH) Chi-square
Secondary
Progression-Free Survival (PFS)
PFS was defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. Progressive Disease (PD): any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 centimeter (cm) in any axis, 50% increase in SPD of \>1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.
Time frame: Up to approximately 4.5 years
Population: ITT population included all randomized participants, enrolled with non-GCB of DLBCL subtype by IHC, and were analyzed according to treatment to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Arm B: Ibrutinib+R-CHOP | Progression-Free Survival (PFS) | 48.56 Months |
| Treatment Arm A: Placebo+R-CHOP | Progression-Free Survival (PFS) | NA Months |
p-value: 0.502795% CI: [0.71, 1.183]Log Rank
Secondary
Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life.
Time frame: Up to approximately 4.5 years
Population: ITT population included all randomized participants, who were enrolled with the non-GCB of DLBCL subtype by IHC. Participants in this population were analyzed according to the treatment to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Arm B: Ibrutinib+R-CHOP | Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) | 11.7 Months |
| Treatment Arm A: Placebo+R-CHOP | Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) | 35.0 Months |
p-value: 0.002195% CI: [1.115, 1.654]Log Rank