A Multicenter Open-Label Phase 1b/2 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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 DLBCL not eligible for transplant. Phase 2 will evaluate only subjects with de novo non-GCB subtype DLBCL. Approximately 46 subjects will be enrolled in the Phase 1b portion. Phase 2 will enroll approximately 55 subjects to ensure enrollment of at least 49 response-evaluable subjects at 20 mg lenalidomide; approximately 28 additional subjects may be enrolled at 25 mg lenalidomide.