Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma

Summary

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Description

PRIMARY OBJECTIVE: I. To evaluate the safety of ibrutinib plus PD 0332991 (palbociclib) in patients with previously treated mantle cell lymphoma (MCL) and select the recommended phase 2 dose schedule. SECONDARY OBJECTIVES: I. To estimate the toxicity profile of ibrutinib plus PD 0332991 (palbociclib...

PRIMARY OBJECTIVE: I. To evaluate the safety of ibrutinib plus PD 0332991 (palbociclib) in patients with previously treated mantle cell lymphoma (MCL) and select the recommended phase 2 dose schedule. SECONDARY OBJECTIVES: I. To estimate the toxicity profile of ibrutinib plus PD 0332991 (palbociclib). II. To estimate the overall response rate (ORR) and complete response (CR) rates. III. To estimate the progression-free survival (PFS). IV. To estimate the response duration (RD). LABORATORY OBJECTIVES: I. To evaluate the genomic profile of MCL cells pre-treatment and at relapse. II. To estimate the pharmacokinetic profile of ibrutinib when given concurrently with PD 0332991 (palbociclib). III. To evaluate the level of cell-free tumor deoxyribonucleic acid (DNA) over time in conjunction with response to therapy. IV. To evaluate the presence of circulating MCL cells over time. OUTLINE: This is a dose-escalation study. Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28 and palbociclib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.

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