NCT04990778

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

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)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Recurrent Mantle Cell Lymphoma
• Refractory Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Eprenetapopt	Given IV
DRUG	Venetoclax	Given PO

Timeline

• Start date: 2021-11-30
• Primary completion: 2023-03-24
• Completion: 2023-03-24
• First posted: 2021-08-04
• Last updated: 2022-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study