Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma


Study Number
66518
Phase
2
Purpose

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.

Full Title

A Phase II Study of Palbociclib (PD-0332991) in Combination with Ibrutinib in Patients with Previously Treated Mantle Cell Lymphoma

ClinicalTrials.Gov ID
NCT03478514

To inquire about participating in these studies, call 1-800-ROSWELL (1-800-767-9355) or e-mail askroswell@roswellpark.org.