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Alkylating agents
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 (SELENE Trial)
Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
Pivotal Trial
Summary
This trial will study whether a combination of ibrutinib with either BR or R-CHOP is effective and safe in treating indolent NHL in adults.
Eligible Conditions
- Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Analysis: Progression Free Survival (PFS): Stratified Analysis
Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL)
Secondary study objectives
Number of Participants With TEAEs: Participants With MZL
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Primary Analysis: Complete Response Rate (CRR): Stratified Analysis
+9 moreSide effects data
From 2016 Phase 2 & 3 trial • 86 Patients • NCT030020384%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Arm BExperimental Treatment7 Interventions
Treatment Arm B = background immune-chemotherapy (BR or R-CHOP) for 6 cycles + PCI-32765 (Ibrutinib).
Group II: Treatment Arm APlacebo Group7 Interventions
Treatment Arm A = background immune-chemotherapy (bendamustine and rituximab \[BR\] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone \[R-CHOP\]) for 6 cycles + placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PCI-32765 (Ibrutinib)
2014
Completed Phase 3
~520
Bendamustine
2015
Completed Phase 3
~3230
Rituximab
1999
Completed Phase 4
~2990
Cyclophosphamide
2010
Completed Phase 4
~2310
Doxorubicin
2012
Completed Phase 3
~8030
Vincristine
2003
Completed Phase 4
~2970
Prednisone
2014
Completed Phase 4
~2500
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
1,008 Previous Clinical Trials
6,402,766 Total Patients Enrolled
41 Trials studying Lymphoma
7,218 Patients Enrolled for Lymphoma
Pharmacyclics LLC.Industry Sponsor
113 Previous Clinical Trials
13,446 Total Patients Enrolled
53 Trials studying Lymphoma
7,479 Patients Enrolled for Lymphoma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
773 Previous Clinical Trials
3,980,793 Total Patients Enrolled
28 Trials studying Lymphoma
4,821 Patients Enrolled for Lymphoma