Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-04-13
8
Participants Needed
4
Research Sites
222 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
To learn if the combination of venetoclax and revumenib can help to control MRD-positive AML.
CONDITIONS
Official 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 of 2 or less if aged 18 years or older; Karnofsky Performance Scale of 50 or more if aged 16 to less than 18 years; Lansky Performance Score of 50 or more if under 16 years
- Known history of NPM1 mutation, KMT2A rearrangement, or NUP98 rearrangement AML
- Bone marrow showing less than 5% leukemia blasts in first remission after high intensity chemotherapy or at least 2 cycles of low intensity therapy, or in second remission after any therapy, with MRD 0.1% or higher by central lab flow cytometry
- No clinically active extramedullary disease
- Baseline heart ejection fraction greater than 40%
- Adequate liver function with direct bilirubin less than 1.5 times upper limit of normal unless due to leukemia, and AST and/or ALT less than 3 times upper limit of normal unless due to leukemia (then up to 5 times allowed)
- Adequate kidney function with estimated glomerular filtration rate 60 mL/min or higher
- Able to swallow pills
- Willing and able to provide informed consent or parent/guardian consent
- At least 14 days since prior cytotoxic or non-cytotoxic therapy or 5 half-lives of prior therapy, whichever is shorter; concurrent CNS prophylaxis or controlled CNS disease therapy allowed
- Women of childbearing potential agree to contraception during study and for 3 months after last treatment; males agree to use contraception during study and for 3 months after last treatment or be sterile
You will not qualify if you...
- Prior treatment with a menin inhibitor
- Expected to receive standard therapy with continued benefit and tolerability
- Expected to undergo stem cell transplantation within 30 days
- Uncontrolled medical condition, laboratory abnormality, or psychiatric illness posing unacceptable risk
- Use of other chemotherapy or anti-leukemic agents except intrathecal chemotherapy for CNS prophylaxis or controlled CNS leukemia, hydroxyurea for rapidly proliferative disease or differentiation syndrome, or steroids for differentiation syndrome
- Severe gastrointestinal or metabolic condition interfering with oral medication absorption
- Concurrent active malignancy under treatment
- Known active hepatitis B or C, or HIV infection
- Pregnant or breastfeeding females
- Active uncontrolled infection
- Major cardiac events or unstable heart conditions in past 6 months, including myocardial infarction, unstable angina, congestive heart failure class II or higher, life-threatening arrhythmia, stroke, or transient ischemic attack
- QTc interval over 450 msec for males or over 470 msec for females
- Any condition or therapy that may confound study results or interfere with full participation
- Clinically active central nervous system leukemia
- On systemic immunosuppressive therapy post-stem cell transplant unless off for specified durations; topical steroids or stable low-dose systemic steroids allowed
- Grade greater than 2 active acute graft-versus-host disease or moderate to severe chronic graft-versus-host disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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