Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

• Status: Completed
• Trial end date: 2020-12-17
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Pharmacyclics LLC.
• Collaborators: Celgene Corporation; Janssen Research & Development, LLC
• Treatments: Lenalidomide; Rituximab; Thalidomide

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 CT scan (>1.5 cm in longest dimension)

• PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN

• Men and women ≥18 years of age

• 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.