Phase 2Active, not recruiting
Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma
A Phase II Study of Palbociclib (PD-0332991) in Combination With Ibrutinib in Patients With Previously Treated Mantle Cell Lymphoma
- Sponsor
- Alliance Foundation Trials, LLC. (Academic or other)
- Enrolment
- 39 enrolled
- Conditions
- Mantle Cell Lymphoma; B Cell Lymphoma
- Interventions
- Palbociclib; Ibrutinib
- Ages
- adults, older adults
- Registry
- NCT03478514
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Progression free survival
History
Study completion expected
Last registry update
Primary completion
Started
Registered