Actively Recruiting
A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes
Led by M.D. Anderson Cancer Center · Updated on 2026-02-19
40
Participants Needed
2
Research Sites
234 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 revumenib (also known as SNDX-5613) can help to control leukemias associated with an increase in expression of HOX genes.
CONDITIONS
Official Title
A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older with weight at least 40 kilograms
- ECOG performance status of 2 or less
- Relapsed or refractory acute leukemia with genetic changes linked to increased HOX gene expression
- White blood cell count below 25,000 per microliter at enrollment (cytoreduction allowed before enrollment)
- Baseline heart ejection fraction greater than 40%
- Adequate liver function with specific bilirubin and liver enzyme limits
- Adequate kidney function with estimated glomerular filtration rate of 60 mL/min or higher
- Participant or guardian willing and able to provide informed consent
- At least 14 days since prior treatment for non-rapidly proliferative disease; specific conditions for rapidly proliferative disease and permitted concurrent therapies
- Women of childbearing potential and males agree to adequate contraception during study and for 3 months after last treatment
You will not qualify if you...
- Uncontrolled medical conditions, laboratory abnormalities, or psychiatric illnesses posing unacceptable risk
- Use of other chemotherapy or anti-leukemic agents during study except specified exceptions
- Severe gastrointestinal or metabolic conditions affecting oral medication absorption
- Active malignancy currently under treatment
- Known active hepatitis B, hepatitis C, or HIV infection
- Pregnant or breastfeeding females
- Active uncontrolled infection
- Major cardiovascular events or conditions within 6 months prior to study entry
- QTc interval above specified limits for males and females
- Any condition or therapy interfering with study participation or results as judged by investigator
- Clinically active central nervous system leukemia
- On immunosuppressive therapy after stem cell transplant within specified time frames
- Active graft-versus-host disease of specified severities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
2
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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