Pemigatinib for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma or Marginal Zone Lymphoma

Recurrent Mantle Cell Lymphoma Clinical Trial

Official title: A Phase II Study of Pemigatinib in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas

Status Not yet recruiting

Clinical Trial Summary

This phase II trial tests how well pemigatinib works in treating patients with mantle cell lymphoma (MCL) or marginal zone lymphoma (MZL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Pemigatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of pemigatinib in patients with relapsed or refractory (R/R) MCL.

II. To evaluate the efficacy of pemigatinib in patients with R/R MZL.

SECONDARY OBJECTIVES:

I. To evaluate the complete response (CR) rate at end of cycle 6 (C6). II. To evaluate the duration of response (DOR). III. To evaluate the median and 2-year progression-free survival (PFS). IV. To evaluate the median and 2-year overall survival (OS).

EXPLORATORY OBJECTIVE:

I. To evaluate the factors predictive of response to pemigatinib and identify mechanism of resistance to therapy.

OUTLINE:

Patients receive pemigatinib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also under computed tomography (CT) and positron emission tomography (PET) or PET/CT and blood sample collection at screening and on study. Patients may also undergo bone marrow aspirate and biopsy during screening and on study.

After completion of study treatment, patients are followed up at 30 days and then every 3 or 6 months. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Mantle-Cell
• Recurrence
• Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
• Recurrent Mantle Cell Lymphoma
• Recurrent Marginal Zone Lymphoma
• Recurrent Nodal Marginal Zone Lymphoma
• Recurrent Splenic Marginal Zone Lymphoma
• Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
• Refractory Mantle Cell Lymphoma
• Refractory Marginal Zone Lymphoma
• Refractory Nodal Marginal Zone Lymphoma
• Refractory Splenic Marginal Zone Lymphoma

• NCT number: NCT06300528
• Study type: Interventional
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials@osumc.edu
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 30, 2024
• Completion date: December 31, 2025