NCT01974440|CompletedPhase 3ResultsDMC

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

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)

Janssen Research & Development, LLC ClinicalTrials.gov

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3 other identifiers

CR102786PCI-32765FLR30012013-003093-27

Study Type

interventional

Target

403

Locations

19 countries

Sites

135

Timeline

RegisteredNov 2013

StartedJan 2014

CompletionJun 2023

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

403

participants targeted

Target at P50-P75 for phase_3 lymphoma

Timeline

Completed

Started Jan 2014

Typical duration for phase_3 lymphoma

Geographic Reach

19 countries

135 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.4 years study duration

First Submitted

Initial submission to the registry

October 28, 2013

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed

3 months until next milestone

Study Start

First participant enrolled

January 31, 2014

Completed

8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed

11 months until next milestone

Results Posted

Study results publicly available

April 14, 2023

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

8.3 years

First QC Date

October 28, 2013

Results QC Date

March 23, 2023

Last Update Submit

May 22, 2025

Conditions

Lymphoma

Keywords

LymphomaFollicular lymphomaMarginal zone lymphomaIndolent Non-Hodgkin lymphomaPCI-32765IbrutinibBendamustineRituximabCyclophosphamideDoxorubicinVincristinePrednisoneR-CHOP

Outcome Measures

Primary Outcomes (2)

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.
Up to 8 years
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.
Up to 8 years

Secondary Outcomes (12)

Primary Analysis: Overall Survival (OS): Stratified Analysis
Up to 8 years
Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL
Up to 8 years
Primary Analysis: Complete Response Rate (CRR): Stratified Analysis
Up to 8 years
Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL
Up to 8 years
Primary Analysis: Overall Response Rate (ORR): Stratified Analysis
Up to 8 years
+7 more secondary outcomes

Study Arms (2)

Treatment Arm A

PLACEBO COMPARATOR

Treatment Arm A = background immune-chemotherapy (bendamustine and rituximab \[BR\] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone \[R-CHOP\]) for 6 cycles + placebo.

Drug: BendamustineDrug: RituximabDrug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: PrednisoneDrug: Placebo

Treatment Arm B

EXPERIMENTAL

Treatment Arm B = background immune-chemotherapy (BR or R-CHOP) for 6 cycles + PCI-32765 (Ibrutinib).

Drug: BendamustineDrug: RituximabDrug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: PrednisoneDrug: PCI-32765 (Ibrutinib)