Clinical Trial

Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma

Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 3 changes
notable Primary completion pushed: 2025-11-10 -> 2025-12-19 2026-07-25
notable Primary completion moved earlier: 2026-03-30 -> 2025-11-10 2026-04-10
minor Completion pushed: 2026-03-30 -> 2026-08-30 2026-04-10
Trial Details
NCT Number NCT03478514
Lead Sponsor Alliance Foundation Trials, LLC.
Collaborators: Pfizer
Conditions Mantle Cell Lymphoma, B Cell Lymphoma
Enrollment 39 participants
Start Date 2018-09-11
Primary Completion 2025-12-19 (estimated)
Study Completion 2026-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-24