Venetoclax and Eprenetapopt for the Treatment of Relapsed of Refractory Mantle Cell Lymphoma
Last updated on August 2021Recruitment
- Estimated Enrollment
- Same as current
Summary
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 veneto...
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.
Tracking Information
- NCT #
- NCT04990778
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Luhua (Michael) Wang M.D. Anderson Cancer Center
Get Well Soon