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Venetoclax and Eprenetapopt for the Treatment of Relapsed of Refractory Mantle Cell Lymphoma

Recurrent Mantle Cell Lymphoma Clinical Trial

Official title:
An Open Label, Phase II Investigator-Initiated Study of Venetoclax and Eprenetapopt (APR-246) in Previously Treated Relapsed/Refractory Patients With Mantle Cell Lymphoma (MCL)

Clinical Trial Summary

This phase II trial investigates the effect of venetoclax and eprenetapopt in treating patients with mantle cell lymphoma that has come back (relapsed) or dose not respond to treatment (refractory). Chemotherapy drugs, such as venetoclax and eprenetapopt, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the efficacy (overall response rate) of the eprenetapopt plus venetoclax combination in relapsed refractory mantle cell lymphoma (MCL) patients (with/without TP53 aberrations). SECONDARY OBJECTIVES: I. To determine the safety profile of the eprenetapopt plus venetoclax combination in relapsed refractory MCL patients. II. To evaluate the overall survival and progression-free survival of the eprenetapopt plus venetoclax combination in relapsed refractory MCL patients. OUTLINE: Patients receive eprenetapopt intravenously (IV) over 6 hours on days 1-4 and venetoclax orally (PO) once daily (QD). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 4 months for 2 years, every 6 months for 5 years, and then annually thereafter. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04990778
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Withdrawn
Phase Phase 2
Start date November 30, 2021
Completion date March 24, 2023
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