NCT02159755

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

A Phase I Trial of Ibrutinib Plus PD 0332991 (Palbociclib) in Patients With Previously Treated Mantle Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of ibrutinib and palbociclib in treating patients with previously treated mantle cell lymphoma. Ibrutinib and palbociclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Palbociclib may also help ibrutinib work better by making cancer cells more sensitive to the drug.

Detailed 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). 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.

Conditions

• Recurrent Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Palbociclib	Given PO
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2014-08-13
• Primary completion: 2018-06-25
• Completion: 2026-12-01
• First posted: 2014-06-10
• Last updated: 2026-04-13

Locations

4 sites across 1 country: United States