NCT03478514

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Alliance Foundation Trials, LLC. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Treatment will consist of: * Palbociclib administered at 100 mg oral once daily for 21 days on followed by 7 days off * Ibrutinib administered at 560 mg oral continuously Patients will continue to receive study drugs until disease progression, unacceptable toxicity, or withdrawal of consent. If at any time one of the agents is held due to toxicity, the other agent may be continued in those patients who are receiving clinical benefit. Response will be assessed by PET/CT and/or CT every 3 cycles while on therapy for the first year and then every 6 cycles thereafter until disease progression or at the investigator's discretion if otherwise medically indicated. A PET will be required to confirm CR. A bone marrow biopsy will be performed in patients with bone marrow involvement at the start of therapy to confirm complete response once patients have otherwise met criteria for CR.

Conditions

• Mantle Cell Lymphoma
• B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Palbociclib	Taken at 100 mg once daily for 21 days, followed by 7 days off
DRUG	Ibrutinib	560 mg taken orally all patients throughout the study

Timeline

• Start date: 2018-09-11
• Primary completion: 2025-11-10
• Completion: 2026-08-30
• First posted: 2018-03-27
• Last updated: 2026-04-09

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study