Actively Recruiting
Phase II Study of Venetoclax and Revumenib Combination for Acute Myeloid Leukemia with Minimal Residual Disease
Led by M.D. Anderson Cancer Center · Updated on 2026-04-13
8
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
S
Syndax Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether the combination of venetoclax and revumenib can help control minimal or measurable residual disease (MRD) in patients with acute myeloid leukemia (AML). This Phase I/II study aims first to determine the safety and best dose of this combination, and then to evaluate how well it clears MRD in AML patients. The study also explores survival outcomes and molecular markers that may predict treatment response or resistance, including in pediatric patients. Participants will receive venetoclax and revumenib together for up to one year, followed by one additional year of venetoclax alone. Venetoclax is taken orally once daily on days 1 to 14 of each treatment cycle, preferably with breakfast and water. If the disease worsens or side effects become intolerable, study drugs will be stopped. The study includes an initial dose-finding phase and a second phase to assess effectiveness. During the study, participants will be closely monitored for safety and side effects over about one year. Researchers will assess the clearance of MRD and measure outcomes such as overall survival and relapse-free survival. Laboratory tests and other assessments will evaluate molecular and genetic markers related to treatment response. Participation may last up to two years including the treatment and follow-up periods.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older with weight at least 45 kg
- ECOG performance status 2 or less (for those 18 years or older); Karnofsky score 50 or higher (for ages 16 to under 18); Lansky score 50 or higher (for under 16 years)
- Confirmed AML with known NPM1 mutation, KMT2A rearrangement, or NUP98 rearrangement
- Bone marrow showing less than 5% blasts and MRD of 0.1% or higher after remission following chemotherapy
- No active extramedullary leukemia
- Baseline heart ejection fraction above 40%
- Adequate liver function with bilirubin and liver enzymes below specific limits unless caused by leukemia
- Adequate kidney function with estimated glomerular filtration rate of 60 mL/min or higher
- Ability to swallow pills
- Willingness to provide informed consent
- Women of childbearing potential must agree to contraception during and for 3 months after treatment; males must be sterile or agree to contraception during and for 3 months after treatment
You will not qualify if you...
- Prior treatment with a menin inhibitor
- Expected to receive standard therapy with ongoing benefit
- Expected stem cell transplant within 30 days
- Uncontrolled medical conditions, psychiatric illness, or laboratory abnormalities posing unacceptable risk
- Use of other chemotherapy or anti-leukemic agents except specific allowed cases
- Severe gastrointestinal or metabolic conditions interfering with oral medication absorption
- Active cancer under treatment besides AML
- Known active Hepatitis B, Hepatitis C, or HIV infection
- Pregnant or breastfeeding females
- Active uncontrolled infection
- Major heart events or unstable heart conditions within 6 months prior to study
- QTc interval above defined limits
- Conditions or therapies that might interfere with study participation or safety
- Active central nervous system leukemia
- On systemic immunosuppressive therapy post stem cell transplant except limited allowed steroids
- Active or severe graft-versus-host disease of specified grades or extent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive the combination of venetoclax and revumenib by mouth for up to 1 year, followed by up to 1 additional year of venetoclax alone. Treatment may stop earlier if the disease worsens or intolerable side effects occur.
1 visit per treatment cycle with venetoclax taken Days 1-14 of each cycle
Trial Site Locations
Total: 4 locations
1
Johns Hopkins University
Baltimore, Maryland, United States, 21218
Actively Recruiting
2
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Ghayas Issa, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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