Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma (NCT03478514)
A Phase II Study of Palbociclib (PD-0332991) in Combination With Ibrutinib in Patients With Previously Treated Mantle Cell Lymphoma
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope National Medical Center — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- City of Hope National Medical Center — Duarte, California
- University of Maryland, Greenebaum Comprehensive Cancer Center — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- St. Joseph Mercy Hospital Cancer Care Center — Ypsilanti, Michigan
- Roswell Park Comprehensive Cancer Center — Buffalo, New York
- Weill Cornell Medical College — New York, New York
- University of North Carolina — Chapel Hill, North Carolina
- Ohio State University — Columbus, Ohio
- Medical University of South Carolina - Hollings Cancer Center — Charleston, South Carolina
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Mantle Cell Lymphoma
- GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma — Rochester, Minnesota
- Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission — Birmingham, Alabama
- Acalabrutinib With R-CHOP in Previously Untreated Mantle Cell Lymphoma — Vancouver, British Columbia
- Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma — Houston, Texas
- Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma — Birmingham, Alabama
- Acalabrutinib-Lenalidomide-Rituximab in Patients With Untreated MCL — New York, New York
Explore by condition: All Mantle Cell Lymphoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.