Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03478514
Study type	Interventional
Source	Alliance Foundation Trials, LLC.
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	September 11, 2018
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT01804686` - A Long-term Extension Study of PCI-32765 (Ibrutinib)	Phase 3
Recruiting	`NCT05976763` - Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma	Phase 3
Recruiting	`NCT03676504` - Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR	Phase 1/Phase 2
Recruiting	`NCT05365659` - IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas	Phase 1
Recruiting	`NCT05471843` - Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma	Phase 1/Phase 2
Recruiting	`NCT05076097` - A Study of OLR in First-line Treatment of Mantle Cell Lymphoma	Phase 2
Active, not recruiting	`NCT03891355` - Carfilzomib + Lenalidomide and Dexamethasone for BTK Inhibitors Relapsed-refractory or Intolerant MCL	Phase 2
Active, not recruiting	`NCT04082936` - A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma	Phase 1/Phase 2
Recruiting	`NCT04883437` - Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas	Phase 2
Terminated	`NCT03585725` - A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma	Early Phase 1
Recruiting	`NCT02892695` - PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma	Phase 1/Phase 2
Terminated	`NCT02877082` - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients	Phase 2
Completed	`NCT01665768` - Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma	Phase 2
Completed	`NCT01437709` - Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant	Phase 2
Completed	`NCT00963534` - Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.	Phase 1/Phase 2
Completed	`NCT00921414` - Mantel Cell Lymphoma Efficacy of Rituximab Maintenance	Phase 3
Withdrawn	`NCT00541424` - Combined CT Colonography and PET Imaging in Mantle Cell Lymphoma	N/A
Completed	`NCT01456351` - Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab	Phase 3
Completed	`NCT01851551` - Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL	Phase 1/Phase 2
Completed	`NCT03295240` - The Study of Bendamustine, Rituximab, Ibrutinib, and Venetoclax in Relapsed, Refractory Mantle Cell Lymphoma	Early Phase 1