Clinical trial · Interventional
Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma
A Multicenter Study of Ibrutinib and Lenalidomide in Combination With DA-EPOCH-R in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
NCT02142049CI-TRIAL-00036936completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma Refractory | — | UNRESOLVED | — |
| Diffuse Large B Cell Lymphoma Relapsed | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DA-EPOCH-R | Drug | — | UNRESOLVED |
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Level 1
- description
- Ibrutinib 560 mg PO + DA-EPOCH-R
- interventionNames
- Drug: Ibrutinib
- Drug: DA-EPOCH-R
- type
- EXPERIMENTAL
- label
- Part 1: Dose Level 2
- description
- Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
- interventionNames
- Drug: Ibrutinib
- Drug: DA-EPOCH-R
- Drug: Lenalidomide
- type
- EXPERIMENTAL
- label
- Part 1: Dose Level 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWilson WH, Phillips T, Popplewell L, de Vos S, Chhabra S, Kimball AS, Beaupre D, Huang DW, Wright G, Kwei K, Ping J, Neuenburg JK, Staudt LM. Phase 1b/2 study of ibrutinib and lenalidomide with dose-adjusted EPOCH-R in patients with relapsed/refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2021 Sep;62(9):2094-2106. doi: 10.1080/10428194.2021.1907371. Epub 2021 Apr 15. PMID 33856277