Phase 3
Completed N=403
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
Lymphoma
Source: ClinicalTrials.gov NCT01974440 ↗
Enrolled (actual)
403
Serious AEs
47.3%
Results posted
Apr 2023
Primary outcomePrimary: Primary Analysis: Progression Free Survival (PFS): Stratified Analysis — 23.75; 40.51 months — p=0.0922
◆ Published Evidence
Established
25citations · ~8 / year
Phase 3 SELENE study: ibrutinib plus BR/R-CHOP in previously treated patients with follicular or marginal zone lymphoma.
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.
Linked Publications
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Phase 3 SELENE study: ibrutinib plus BR/R-CHOP in previously treated patients with follicular or marginal zone lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Analysis: Progression Free Survival (PFS): Stratified Analysis |
23.75; 40.51 | 0.0922 |
| PRIMARY Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL) |
91.63; NA | 0.4505 |
| SECONDARY Primary Analysis: Overall Survival (OS): Stratified Analysis |
NA; NA | — |
| SECONDARY Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL |
NA; NA | — |
| SECONDARY Primary Analysis: Complete Response Rate (CRR): Stratified Analysis |
50.2; 55 | — |
| SECONDARY Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL |
60.7; 64.3 | — |
| SECONDARY Primary Analysis: Overall Response Rate (ORR): Stratified Analysis |
90.5; 91.6 | — |
| SECONDARY Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL |
82.1; 89.3 | — |
| SECONDARY Primary Analysis: Duration of Response (DOR): Stratified Analysis |
21.68; 44.32 | — |
| SECONDARY Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL |
89.17; NA | — |
| SECONDARY Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire |
37.03; 24.84 | — |
| SECONDARY 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 |
36.83; 58.91 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
197; 199 | — |
| SECONDARY Number of Participants With TEAEs: Participants With MZL |
28; 28 | — |
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
Data sourced from ClinicalTrials.gov (NCT01974440) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.