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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01974440
Registration number
NCT01974440
Ethics application status
Date submitted
28/10/2013
Date registered
1/11/2013
Date last updated
13/09/2023
Titles & IDs
Public 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
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Scientific 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)
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Secondary ID [1]
0
0
PCI-32765FLR3001
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Secondary ID [2]
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0
CR102786
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Universal Trial Number (UTN)
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Trial acronym
SELENE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma
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0
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Condition category
Condition code
Cancer
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0
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bendamustine
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone
Treatment: Drugs - PCI-32765 (Ibrutinib)
Treatment: Drugs - Placebo
Placebo Comparator: Treatment Arm A - Treatment Arm A = background immune-chemotherapy (bendamustine and rituximab [BR] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) for 6 cycles + placebo.
Experimental: Treatment Arm B - Treatment Arm B = background immune-chemotherapy (BR or R-CHOP) for 6 cycles + PCI-32765 (Ibrutinib).
Treatment: Drugs: Bendamustine
90 milligram per meter square (mg/m^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6.
Treatment: Drugs: Rituximab
375 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.
Treatment: Drugs: Cyclophosphamide
750 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.
Treatment: Drugs: Doxorubicin
50 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.
Treatment: Drugs: Vincristine
1.4 mg/m^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6.
Treatment: Drugs: Prednisone
100 mg administered orally on Days 1 to 5 of Cycles 1 to 6.
Treatment: Drugs: PCI-32765 (Ibrutinib)
560 mg (4*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1.
Treatment: Drugs: Placebo
Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary Analysis: Progression Free Survival (PFS): Stratified Analysis
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 8 years
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Primary outcome [2]
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Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL)
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Assessment method [2]
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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.
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Timepoint [2]
0
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Up to 8 years
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Secondary outcome [1]
0
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Primary Analysis: Overall Survival (OS): Stratified Analysis
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 8 years
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Secondary outcome [2]
0
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Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL
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Assessment method [2]
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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.
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Timepoint [2]
0
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Up to 8 years
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Secondary outcome [3]
0
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Primary Analysis: Complete Response Rate (CRR): Stratified Analysis
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Assessment method [3]
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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.
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Timepoint [3]
0
0
Up to 8 years
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Secondary outcome [4]
0
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Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL
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Assessment method [4]
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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.
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Timepoint [4]
0
0
Up to 8 years
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Secondary outcome [5]
0
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Primary Analysis: Overall Response Rate (ORR): Stratified Analysis
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Assessment method [5]
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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.
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Timepoint [5]
0
0
Up to 8 years
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Secondary outcome [6]
0
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Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL
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Assessment method [6]
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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.
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Timepoint [6]
0
0
Up to 8 years
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Secondary outcome [7]
0
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Primary Analysis: Duration of Response (DOR): Stratified Analysis
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Assessment method [7]
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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.
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Timepoint [7]
0
0
Up to 8 years
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Secondary outcome [8]
0
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Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL
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Assessment method [8]
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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.
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Timepoint [8]
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Up to 8 years
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Secondary outcome [9]
0
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Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire
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Assessment method [9]
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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.
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Timepoint [9]
0
0
Up to 8 years
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Secondary outcome [10]
0
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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
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Assessment method [10]
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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.
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Timepoint [10]
0
0
Up to 8 years
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Secondary outcome [11]
0
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Primary Analysis: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [11]
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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.
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Timepoint [11]
0
0
Up to 8 years
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Secondary outcome [12]
0
0
Supplementary Analysis: Number of Participants With TEAEs: Participants With MZL
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Assessment method [12]
0
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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.
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Timepoint [12]
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Up to 8 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/06/2023
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Sample size
Target
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Accrual to date
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Final
405
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Fitzroy
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- Heidelberg
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- South Brisbane
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Recruitment hospital [5]
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- Wahroonga
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- Westmead
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- Adelaide
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Recruitment postcode(s) [2]
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- Fitzroy
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Recruitment postcode(s) [3]
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- Heidelberg
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Recruitment postcode(s) [4]
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- South Brisbane
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Recruitment postcode(s) [5]
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- Wahroonga
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Recruitment postcode(s) [6]
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- Westmead
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Illinois
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Louisiana
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Maine
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Maryland
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Cordoba
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Argentina
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La Capital
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Argentina
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Mendoza
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Argentina
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Santa Fe
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Anderlecht
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Wilrijk
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Porto Alegre
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Brazil
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Beijing
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China
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China
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China
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China
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Nice Cedex 2
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France
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France
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Pierre Benite
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France
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Rennes
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Germany
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Berlin
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Germany
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Gießen
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Germany
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Göttingen
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Germany
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Ludwigshafen, Rp
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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Munchen
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Wiesbaden
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Israel
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Hadera
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Israel
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Haifa
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Israel
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State/province [63]
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0
Jerusalem
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Country [64]
0
0
Israel
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State/province [64]
0
0
Nahariya
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Country [65]
0
0
Israel
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State/province [65]
0
0
Netanya
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Country [66]
0
0
Israel
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State/province [66]
0
0
Petah Tikva
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Country [67]
0
0
Israel
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State/province [67]
0
0
Ramat Gan
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Country [68]
0
0
Japan
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State/province [68]
0
0
Chuo-Ku
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Country [69]
0
0
Japan
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State/province [69]
0
0
Hiroshima-shi
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Country [70]
0
0
Japan
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State/province [70]
0
0
Isehara
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Country [71]
0
0
Japan
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State/province [71]
0
0
Kobe
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Country [72]
0
0
Japan
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State/province [72]
0
0
Nagoya-shi
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Country [73]
0
0
Japan
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State/province [73]
0
0
Osaka-Sayama-shi
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Country [74]
0
0
Japan
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State/province [74]
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0
Sapporo-shi
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Country [75]
0
0
Japan
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State/province [75]
0
0
Sendai-shi
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Country [76]
0
0
Japan
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State/province [76]
0
0
Suita-shi
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Country [77]
0
0
Japan
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State/province [77]
0
0
Tokyo
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Country [78]
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0
Korea, Republic of
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State/province [78]
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0
Jeollanam-do
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Country [79]
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0
Korea, Republic of
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State/province [79]
0
0
Seoul
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Country [80]
0
0
Poland
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State/province [80]
0
0
Gdynia
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Country [81]
0
0
Poland
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State/province [81]
0
0
Olsztyn
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Country [82]
0
0
Poland
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State/province [82]
0
0
Warszawa
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Country [83]
0
0
Puerto Rico
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State/province [83]
0
0
Bayamon
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Country [84]
0
0
Puerto Rico
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State/province [84]
0
0
Ponce
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Country [85]
0
0
Puerto Rico
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State/province [85]
0
0
San Juan
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Country [86]
0
0
Russian Federation
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State/province [86]
0
0
Krasnodar
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Country [87]
0
0
Russian Federation
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State/province [87]
0
0
Moscow
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Country [88]
0
0
Russian Federation
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State/province [88]
0
0
Nizny Novgorod
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Country [89]
0
0
Russian Federation
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State/province [89]
0
0
Petrozavodsk
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Country [90]
0
0
Russian Federation
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State/province [90]
0
0
Pyatigorsk
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Country [91]
0
0
Russian Federation
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State/province [91]
0
0
Rostov-On-Don
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Country [92]
0
0
Russian Federation
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State/province [92]
0
0
St. Petersburg
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Country [93]
0
0
Russian Federation
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State/province [93]
0
0
Syktyvkar
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Country [94]
0
0
Russian Federation
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State/province [94]
0
0
Volgograd
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Country [95]
0
0
Spain
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State/province [95]
0
0
Barcelona
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Country [96]
0
0
Spain
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State/province [96]
0
0
Madrid
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Country [97]
0
0
Spain
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State/province [97]
0
0
Pozuelo de Alarcon
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Country [98]
0
0
Spain
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State/province [98]
0
0
Salamanca
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Country [99]
0
0
Sweden
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State/province [99]
0
0
Göteborg
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Country [100]
0
0
Sweden
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State/province [100]
0
0
Linköping
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Country [101]
0
0
Sweden
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State/province [101]
0
0
Luleå
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Country [102]
0
0
Sweden
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State/province [102]
0
0
Uppsala
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Country [103]
0
0
Turkey
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State/province [103]
0
0
Ankara
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Country [104]
0
0
Turkey
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State/province [104]
0
0
Antalya
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Country [105]
0
0
Turkey
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State/province [105]
0
0
Istanbul
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Country [106]
0
0
Turkey
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State/province [106]
0
0
Izmir
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Country [107]
0
0
Turkey
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State/province [107]
0
0
Kayseri
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Country [108]
0
0
Ukraine
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State/province [108]
0
0
Cherkasy
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Country [109]
0
0
Ukraine
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State/province [109]
0
0
Ivano-Frankivsk
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Country [110]
0
0
Ukraine
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State/province [110]
0
0
Khmelnitskiy
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Country [111]
0
0
Ukraine
Query!
State/province [111]
0
0
Kiev
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Country [112]
0
0
Ukraine
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State/province [112]
0
0
Lviv
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Country [113]
0
0
Ukraine
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State/province [113]
0
0
Uzhgorod
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Country [114]
0
0
United Kingdom
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State/province [114]
0
0
Glasgow
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Country [115]
0
0
United Kingdom
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State/province [115]
0
0
London
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Country [116]
0
0
United Kingdom
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State/province [116]
0
0
Newcastle upon Tyne
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Country [117]
0
0
United Kingdom
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State/province [117]
0
0
Plymouth
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Country [118]
0
0
United Kingdom
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State/province [118]
0
0
Portsmouth
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Country [119]
0
0
United Kingdom
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State/province [119]
0
0
Sutton
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Country [120]
0
0
United Kingdom
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State/province [120]
0
0
Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
0
0
Pharmacyclics LLC.
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01974440
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
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Address
0
0
Janssen Research & Development, LLC
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Country
0
0
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Phone
0
0
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Fax
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0
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Email
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0
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Contact person for public queries
Name
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01974440
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