Clinical Trial: NCT03478514
Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Alliance Foundation Trials, LLC. |
| Information Provided By: | Alliance Foundation Trials, LLC. |
| Last Update Posted: | 2026-10-02 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Palbociclib
- Drug: Ibrutinib
Other Study ID Numbers
- AFT-32
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Estimated)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Alliance Foundation Trials, LLC. |
| Information Provided By: | Alliance Foundation Trials, LLC. |
| Last Update Posted: | 2026-10-02 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Palbociclib
- Drug: Ibrutinib
Other Study ID Numbers
- AFT-32