Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacyclics LLC.
• Collaborator: Celgene Corporation
• Treatments: Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Lenalidomide; Liposomal doxorubicin; Prednisone; Rituximab; Thalidomide; Vincristine

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