Phase 2
N=134
Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Relapsed Diffuse Large B-Cell Lymphoma · Refractory Diffuse Large B-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02077166 ↗Enrolled (actual)
134
Serious AEs
63.4%
Results posted
Feb 2022
Primary outcome: Primary: Phase 1b: Recommended Phase 2 Dose of Lenalidomide in Combination With Fixed Doses of Ibrutinib and Rituximab in Participants With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL) — 20 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibrutinib (Drug); Lenalidomide (Drug); Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pharmacyclics LLC.
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1b: Recommended Phase 2 Dose of Lenalidomide in Combination With Fixed Doses of Ibrutinib and Rituximab in Participants With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL) |
20 | — |
| PRIMARY Phase 1b: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs |
12; 7; 9; 9; 8; 11 | — |
| PRIMARY Phase 2: Overall Response Rate (ORR) |
52.8; 43.8; 49.4 | — |
| SECONDARY Phase 1b: ORR |
44.4; 0; 71.4; 22.2; 75.0; 42.5 | — |
| SECONDARY Phase 1b: Complete Response (CR) Rate |
33.3; 0; 42.9; 11.1; 50.0; 27.5 | — |
| SECONDARY Phase 2: CR Rate |
32.1; 21.9; 28.2 | — |
| SECONDARY Phase 2: Duration of Response (DOR) |
38.3; 28.6; 38.3 | — |
| SECONDARY Phase 2: Progression Free Survival (PFS) |
5.4; 4.7; 5.4 | — |
| SECONDARY Phase 2: Overall Survival (OS) |
14.7; 11.6; 14.2 | — |
| SECONDARY Phase 2: Number of Participants With TEAEs, Serious TEAEs, and Discontinuations Due to TEAEs |
55; 34; 89; 51; 30; 81 | — |
Summary
This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for transplant.
Eligibility Criteria
Inclusion Criteria
- Pathologically confirmed relapsed/ refractory DLBCL
- Must have previously received first line treatment regimen
- Must be ineligible for high dose therapy/ stem cell transplantation
- Measurable disease sites on computed tomography (CT) scan (>1.5 cm in longest dimension)
- prothrombin time/international normalized ratio (PT/INR) < 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT; activated partial thromboplastin time [aPTT]) <1.5 x ULN
- Men and women ≥18 years of age
- Eastern Cooperative Oncology Group (ECOG) < 2
- Adequate hepatic and renal function
- Adequate hematologic function
Exclusion Criteria
- Medically apparent central nervous system lymphoma or leptomeningeal disease
- History of allogeneic stem-cell (or other organ) transplantation
- Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks
- Radio- or toxin-immunoconjugates within 10 weeks
- Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.
Data sourced from ClinicalTrials.gov (NCT02077166). 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.