Phase 2
N=35
Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Diffuse Large B Cell Lymphoma Relapsed · Diffuse Large B Cell Lymphoma Refractory
Bottom Line
View on ClinicalTrials.gov: NCT02142049 ↗Enrolled (actual)
35
Serious AEs
80.5%
Results posted
Feb 2019
Primary outcome: Primary: Number of Participants With Dose-Limiting Toxicities as a Measure of Safety and Tolerability — 0; 0; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibrutinib (Drug); DA-EPOCH-R (Drug); Lenalidomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pharmacyclics LLC.
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-Limiting Toxicities as a Measure of Safety and Tolerability |
0; 0; 0; 1; 1 | — |
| PRIMARY Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy-ORR |
16; 9 | — |
| SECONDARY Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy |
1; 2; 0; 3; 6 | — |
| SECONDARY Number of Subjects With Adverse Events as a Measure of Safety and Tolerability |
26; 14 | — |
| SECONDARY Progression Free Survival (PFS) and Overall Survival (OS) as a Measure of Efficacy |
4.86; 4.86; 15.84; 15.84 | — |
| SECONDARY Duration of Response (DOR) |
3.94; 4.09 | — |
Summary
This is a Phase 1b/2, open-label, non-randomized multicenter study to assess the safety and efficacy of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL).
Eligibility Criteria
Major inclusion criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- Pathologically confirmed relapsed/refractory DLBCL
- Subjects must have ≥1 measurable disease site on CT scan (≥ 1.5 cm in longest dimension).
- Adequate hepatic and renal function:
- AST or ALT ≤2.5 x ULN
- Serum Creatinine ≤ 2.0 mg/dL and creatinine clearance ≥60 mL/min/1.73
- Bilirubin ≤1.5 x ULN
- Adequate hematologic function:
- ANC >1,000 cells/mm3
- Platelets ≥75,000 cells/mm3
- Hemoglobin ≥8.0 g/dL
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) must be ≤1.5 x the upper limit of the normal range (ULN)
- Must be registered into the Revlimid REMS™program and be willing to comply with the requirements of Revlimid REMS™.
Major Exclusion Criteria:
- Known central nervous system lymphoma
- Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks
- Radio- or toxin-immunoconjugates within 10 weeks
- Prior allogenetic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug
Data sourced from ClinicalTrials.gov (NCT02142049). 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.