Back to resultsA Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma (SELENE)
Primary Purpose
Lymphoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bendamustine
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
PCI-32765 (Ibrutinib)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Lymphoma, Follicular lymphoma, Marginal zone lymphoma, Indolent Non-Hodgkin lymphoma, PCI-32765, Ibrutinib, Bendamustine, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, R-CHOP
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of B-cell indolent Non-Hodgkin lymphoma with histological subtype limited to follicular lymphoma or marginal zone lymphoma, at initial diagnosis and without evidence of pathological transformation or clinical signs suggesting transformation
- At least 1 prior treatment with a CD20 antibody combination chemo-immunotherapy regimen
- Disease that has relapsed or was refractory after prior chemo-immunotherapy
- At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma 2007
- Eastern Cooperative Oncology Group performance status grade 0 or 1
- Laboratory values within protocol-defined parameters
- Agrees to protocol-defined use of effective contraception
- Men must agree not to donate sperm during and after the study for 6 months after the last dose of bendamustine, 12 months after the last dose of rituximab, or 3 months after the last dose of study medication, whichever is later
- Women of childbearing potential must have a negative serum or urine pregnancy test at Screening
Exclusion Criteria:
- Prior treatment according to protocol-defined criteria
- Unable to receive background chemotherapy based on prior treatment history and cardiac function
- Known central nervous system lymphoma
- Diagnosed or treated for malignancy other than indolent Non-Hodgkin lymphoma
- History of stroke or intracranial hemorrhage within 6 months prior to randomization
- Requires anticoagulation with warfarin or equivalent Vitamin K antagonists
- Requires treatment with strong CYP3A inhibitors
- Clinically significant cardiovascular disease
- Known history of human immunodeficiency virus or active hepatitis C virus (HCV; ribonucleic acid [RNA] polymerase chain reaction [PCR]-positive) or active hepatitis B virus (HBV; DNA PCR-positive) infection or any uncontrolled active systemic infection requiring intravenous antibiotics
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
- Women who are pregnant or breastfeeding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Treatment Arm A
Treatment Arm B
Arm Description
Treatment Arm A = background immune-chemotherapy (bendamustine and rituximab [BR] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) for 6 cycles + placebo.
Treatment Arm B = background immune-chemotherapy (BR or R-CHOP) for 6 cycles + PCI-32765 (Ibrutinib).
Outcomes
Primary Outcome Measures
Primary Analysis: Progression Free Survival (PFS): Stratified Analysis
PFS was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 centimeters (cm) in any axis, 50% increase in sum of product of diameters (SPD) of greater than (>) 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL)
PFS in MZL participants was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from CR or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by >=50% of previously involved sites from nadir disease progression 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. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Secondary Outcome Measures
Primary Analysis: Overall Survival (OS): Stratified Analysis
OS was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL
OS in MZL participants was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Primary Analysis: Complete Response Rate (CRR): Stratified Analysis
CRR was defined as the percentage of participants who achieved a complete response (CR); (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if positron emission tomography (PET) negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL
CRR in MZL participants was defined as the percentage of participants who achieved a CR (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; 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 and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Primary Analysis: Overall Response Rate (ORR): Stratified Analysis
ORR was defined as the percentage of participants who achieved a CR or partial response (PR). Criteria for CR: disappearance of all evidence of disease; 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 and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL
ORR in MZL participants was defined as the percentage of participants who achieved a CR or PR. Criteria for CR: disappearance of all evidence of disease; 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 and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Primary Analysis: Duration of Response (DOR): Stratified Analysis
DOR was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; 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 and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL
DOR in MZL participants was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; 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 and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire
Time-to-worsening in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life.
Supplementary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire: Participants With MZL
TTW in MZL participants in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life.
Primary Analysis: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication.
Supplementary Analysis: Number of Participants With TEAEs: Participants With MZL
Number of MZL participants with TEAEs were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication.
Full Information
NCT ID
NCT01974440
First Posted
October 28, 2013
Last Updated
August 16, 2023
Sponsor
Janssen Research & Development, LLC
Collaborators
Pharmacyclics LLC.
1. Study Identification
Unique Protocol Identification Number
NCT01974440
Brief Title
A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma
Acronym
SELENE
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2014 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
June 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
Pharmacyclics LLC.
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants with previously treated indolent Non-Hodgkin lymphoma.
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 in approximately 400 adult participants with follicular lymphoma or marginal zone lymphoma. The study will include the following phases: Screening, Treatment, and a Post-treatment Follow-up. Eligible participants will be randomly assigned in a 1:1 ratio to either treatment Arm A (background immune-chemotherapy + placebo) or treatment Arm B (background immune-chemotherapy + 560 milligram [mg] of ibrutinib). All participants will receive 6 cycles of background immune-chemotherapy with either BR or R-CHOP in combination with either placebo (Arm A) or ibrutinib (Arm B). Selection of background immune-chemotherapy will be based on prior treatment history and cardiac function. After completion of background immune-chemotherapy, study drug (ibrutinib or placebo) will continue until disease progression, unacceptable toxicity, or study end, whichever comes first. Assessment of tumor response and progression will be conducted in accordance with the Revised Response Criteria for Malignant Lymphoma. Serial pharmacokinetic (study of what a drug does to the body) blood samples will be collected. Safety will be assessed throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Lymphoma, Follicular lymphoma, Marginal zone lymphoma, Indolent Non-Hodgkin lymphoma, PCI-32765, Ibrutinib, Bendamustine, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, R-CHOP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
405 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm A
Arm Type
Placebo Comparator
Arm Description
Treatment Arm A = background immune-chemotherapy (bendamustine and rituximab [BR] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) for 6 cycles + placebo.
Arm Title
Treatment Arm B
Arm Type
Experimental
Arm Description
Treatment Arm B = background immune-chemotherapy (BR or R-CHOP) for 6 cycles + PCI-32765 (Ibrutinib).
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Intervention Description
90 milligram per meter square (mg/m^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
750 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
50 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
1.4 mg/m^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
100 mg administered orally on Days 1 to 5 of Cycles 1 to 6.
Intervention Type
Drug
Intervention Name(s)
PCI-32765 (Ibrutinib)
Intervention Description
560 mg (4*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1.
Primary Outcome Measure Information:
Title
Primary Analysis: Progression Free Survival (PFS): Stratified Analysis
Description
PFS was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 centimeters (cm) in any axis, 50% increase in sum of product of diameters (SPD) of greater than (>) 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Time Frame
Up to 8 years
Title
Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL)
Description
PFS in MZL participants was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from CR or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by >=50% of previously involved sites from nadir disease progression 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. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Time Frame
Up to 8 years
Secondary Outcome Measure Information:
Title
Primary Analysis: Overall Survival (OS): Stratified Analysis
Description
OS was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Time Frame
Up to 8 years
Title
Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL
Description
OS in MZL participants was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Time Frame
Up to 8 years
Title
Primary Analysis: Complete Response Rate (CRR): Stratified Analysis
Description
CRR was defined as the percentage of participants who achieved a complete response (CR); (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if positron emission tomography (PET) negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Time Frame
Up to 8 years
Title
Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL
Description
CRR in MZL participants was defined as the percentage of participants who achieved a CR (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; 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 and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Time Frame
Up to 8 years
Title
Primary Analysis: Overall Response Rate (ORR): Stratified Analysis
Description
ORR was defined as the percentage of participants who achieved a CR or partial response (PR). Criteria for CR: disappearance of all evidence of disease; 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 and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Time Frame
Up to 8 years
Title
Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL
Description
ORR in MZL participants was defined as the percentage of participants who achieved a CR or PR. Criteria for CR: disappearance of all evidence of disease; 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 and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Time Frame
Up to 8 years
Title
Primary Analysis: Duration of Response (DOR): Stratified Analysis
Description
DOR was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; 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 and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Time Frame
Up to 8 years
Title
Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL
Description
DOR in MZL participants was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; 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 and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Time Frame
Up to 8 years
Title
Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire
Description
Time-to-worsening in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). 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 8 years
Title
Supplementary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire: Participants With MZL
Description
TTW in MZL participants in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). 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 8 years
Title
Primary Analysis: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication.
Time Frame
Up to 8 years
Title
Supplementary Analysis: Number of Participants With TEAEs: Participants With MZL
Description
Number of MZL participants with TEAEs were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication.
Time Frame
Up to 8 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of B-cell indolent Non-Hodgkin lymphoma with histological subtype limited to follicular lymphoma or marginal zone lymphoma, at initial diagnosis and without evidence of pathological transformation or clinical signs suggesting transformation
At least 1 prior treatment with a CD20 antibody combination chemo-immunotherapy regimen
Disease that has relapsed or was refractory after prior chemo-immunotherapy
At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma 2007
Eastern Cooperative Oncology Group performance status grade 0 or 1
Laboratory values within protocol-defined parameters
Agrees to protocol-defined use of effective contraception
Men must agree not to donate sperm during and after the study for 6 months after the last dose of bendamustine, 12 months after the last dose of rituximab, or 3 months after the last dose of study medication, whichever is later
Women of childbearing potential must have a negative serum or urine pregnancy test at Screening
Exclusion Criteria:
Prior treatment according to protocol-defined criteria
Unable to receive background chemotherapy based on prior treatment history and cardiac function
Known central nervous system lymphoma
Diagnosed or treated for malignancy other than indolent Non-Hodgkin lymphoma
History of stroke or intracranial hemorrhage within 6 months prior to randomization
Requires anticoagulation with warfarin or equivalent Vitamin K antagonists
Requires treatment with strong CYP3A inhibitors
Clinically significant cardiovascular disease
Known history of human immunodeficiency virus or active hepatitis C virus (HCV; ribonucleic acid [RNA] polymerase chain reaction [PCR]-positive) or active hepatitis B virus (HBV; DNA PCR-positive) infection or any uncontrolled active systemic infection requiring intravenous antibiotics
Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
Women who are pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Gilbert
State/Province
Arizona
Country
United States
City
Campbell
State/Province
California
Country
United States
City
Duarte
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Orange
State/Province
California
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Maywood
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Westwood
State/Province
Kansas
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Lafayette
State/Province
Louisiana
Country
United States
City
Scarborough
State/Province
Maine
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Battle Creek
State/Province
Michigan
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Saint Louis Park
State/Province
Minnesota
Country
United States
City
Denville
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Pinehurst
State/Province
North Carolina
Country
United States
City
Bend
State/Province
Oregon
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Sioux Falls
State/Province
South Dakota
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Lubbock
State/Province
Texas
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Green Bay
State/Province
Wisconsin
Country
United States
City
Buenos Aires
Country
Argentina
City
Ciudad Autonoma Buenos Aires
Country
Argentina
City
Cordoba
Country
Argentina
City
La Capital
Country
Argentina
City
Mendoza
Country
Argentina
City
Santa Fe
Country
Argentina
City
Adelaide
Country
Australia
City
Fitzroy
Country
Australia
City
Heidelberg
Country
Australia
City
South Brisbane
Country
Australia
City
Wahroonga
Country
Australia
City
Westmead
Country
Australia
City
Anderlecht
Country
Belgium
City
Edegem
Country
Belgium
City
Gent
Country
Belgium
City
Leuven
Country
Belgium
City
Namur
Country
Belgium
City
Wilrijk
Country
Belgium
City
Porto Alegre
Country
Brazil
City
Rio De Janeiro
Country
Brazil
City
Salvador
Country
Brazil
City
Sao Paulo
Country
Brazil
City
São Paulo
Country
Brazil
City
Beijing
Country
China
City
Chengdu
Country
China
City
Guangzhou
Country
China
City
Hangzhou
Country
China
City
Harbin
Country
China
City
Nanjing
Country
China
City
Shanghai
Country
China
City
Tianjin
Country
China
City
Nice Cedex 2
Country
France
City
Paris
Country
France
City
Pessac
Country
France
City
Pierre Benite
Country
France
City
Rennes
Country
France
City
Berlin
Country
Germany
City
Gießen
Country
Germany
City
Göttingen
Country
Germany
City
Ludwigshafen, Rp
Country
Germany
City
Magdeburg
Country
Germany
City
Mainz
Country
Germany
City
Munchen
Country
Germany
City
Wiesbaden
Country
Germany
City
Hadera
Country
Israel
City
Haifa
Country
Israel
City
Jerusalem
Country
Israel
City
Nahariya
Country
Israel
City
Netanya
Country
Israel
City
Petah Tikva
Country
Israel
City
Ramat Gan
Country
Israel
City
Chuo-Ku
Country
Japan
City
Hiroshima-shi
Country
Japan
City
Isehara
Country
Japan
City
Kobe
Country
Japan
City
Nagoya-shi
Country
Japan
City
Osaka-Sayama-shi
Country
Japan
City
Sapporo-shi
Country
Japan
City
Sendai-shi
Country
Japan
City
Suita-shi
Country
Japan
City
Tokyo
Country
Japan
City
Jeollanam-do
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Gdynia
Country
Poland
City
Olsztyn
Country
Poland
City
Warszawa
Country
Poland
City
Bayamon
Country
Puerto Rico
City
Ponce
Country
Puerto Rico
City
San Juan
Country
Puerto Rico
City
Krasnodar
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Nizny Novgorod
Country
Russian Federation
City
Petrozavodsk
Country
Russian Federation
City
Pyatigorsk
Country
Russian Federation
City
Rostov-On-Don
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Syktyvkar
Country
Russian Federation
City
Volgograd
Country
Russian Federation
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Pozuelo de Alarcon
Country
Spain
City
Salamanca
Country
Spain
City
Göteborg
Country
Sweden
City
Linköping
Country
Sweden
City
Luleå
Country
Sweden
City
Uppsala
Country
Sweden
City
Ankara
Country
Turkey
City
Antalya
Country
Turkey
City
Istanbul
Country
Turkey
City
Izmir
Country
Turkey
City
Kayseri
Country
Turkey
City
Cherkasy
Country
Ukraine
City
Ivano-Frankivsk
Country
Ukraine
City
Khmelnitskiy
Country
Ukraine
City
Kiev
Country
Ukraine
City
Lviv
Country
Ukraine
City
Uzhgorod
Country
Ukraine
City
Glasgow
Country
United Kingdom
City
London
Country
United Kingdom
City
Newcastle upon Tyne
Country
United Kingdom
City
Plymouth
Country
United Kingdom
City
Portsmouth
Country
United Kingdom
City
Sutton
Country
United Kingdom
City
Swansea
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma
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