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.
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.
Mantle cell lymphoma,
b cell lymphomas,
b cell lymphoma
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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