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
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT06284486
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Venetoclax — DRUGGiven by PO
- Revumenib — DRUGGiven by PO
Study Details
To learn if the combination of venetoclax and revumenib can help to control MRD-positive AML.
Key Dates
- Start date
- Sep 23, 2024
- Status verified
- Apr 2026
- Primary completion
- Dec 30, 2026
- Completion
- Dec 30, 2028
Study Design
- Enrollment
- 8 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Venetoclax + RevumenibParticipants may receive the combination of venetoclax and revumenib for up to 1 year, and then 1 more year of venetoclax alone. You will no longer be able to take the study drug(s) if the disease gets worse or if intolerable side effects occur. Participants will take venetoclax by mouth on 1 time a day at about the same time each day, on Days 1-14 of each cycle. Take each dose with about 1 cup of water within 30 minutes after a meal, preferably breakfast.
Primary Outcome Measure
Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]
Central Contacts
- Ghayas Issa, MD(713) 745-6798
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21218 | Alexander Ambinder, MD |
| Dana-Farber Cancer Center | Boston | Massachusetts | 02215 | Jacqueline Garcia, MD |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Aaron Goldberg, MD (PRINCIPAL_INVESTIGATOR) |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Ghayas Issa, MD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Baltimore, MD
By condition
By specialty
Related Studies
- Monitoring Minimal Residual Disease of Patients With Acute Myelogenous Leukemia or High Grade Myelodysplastic SyndromeRecruiting · University of Rochester · Rochester, New York
- Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid LeukemiaPHASE2 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
- PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid LeukemiaPHASE1 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
- KIR Favorable Mismatched Haplo Transplant and KIR Polymorphism in ALL/AML/MDS Allo-HCT ChildrenPHASE2 · Enrolling By Invitation · Michael Pulsipher · Los Angeles, California