Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
The proposed study is a single-arm, multi-center, open-label phase II study of the
combination of palbociclib and ibrutinib in patients with previously treated mantle cell
lymphoma to evaluate the efficacy of this combination, with the primary objective of the
study being to assess median PFS and the secondary objectives to include ORR, CR, DOR, OS and
toxicity. Subjects will be enrolled and treated with palbociclib and ibrutinib with each
cycle of therapy being 28 days. Treatment will be based on the recommended phase II dose
(RP2D) from the phase I combination trial.