A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib
M.D. Anderson Cancer Center
Summary
To learn if the combination of venetoclax and revumenib can help to control MRD-positive AML.
Description
Primary Objectives * Phase I: To determine the safety, tolerability, and recommended phase II dose (RP2D) of the combination of revumenib and venetoclax for patients with acute myeloid leukemia (AML) and detectable minimal or measurable residual disease (MRD). * Phase II: To assess the efficacy of the combination of venetoclax and revumenib in clearance of MRD in patients with AML. Secondary Objectives * To assess overall survival (OS), relapse-free survival (RFS), event-free survival (EFS) and duration of response (DOR). * To determine clinical flow and genetic MRD concordance rate Explor…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 12 years with weight ≥ 45Kg. 2. ECOG performance status of ≤ 2. (if aged ≥18 years); Karnofsky Performance Scale of ≥50 (if aged ≥16 years and \<18 years); Lansky Performance Score of ≥50 (if aged \<16 years). 3. Leukemia status: * Known history of NPM1mt, or KMT2Ar, or NUP98r AML. * Bone marrow assessment showing no leukemia by morphology (blasts \<5%) in first remission following high intensity chemotherapy or at least 2 cycles of low intensity therapy (e.g. hypomethylating agent or low-dose cytarabine-based), or in second remission following any therapy,…
Interventions
- DrugVenetoclax
Given by PO
- DrugRevumenib
Given by PO
Locations (4)
- Johns Hopkins UniversityBaltimore, Maryland
- Dana-Farber Cancer CenterBoston, Massachusetts
- Memorial Sloan Kettering Cancer CenterNew York, New York
- MD Anderson Cancer CenterHouston, Texas