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
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 evaluating revumenib, a drug also known as SNDX-5613, in people with leukemia linked to increased expression of HOX genes. This Phase II study aims to assess how well revumenib works in controlling such leukemias and to understand its effects on measurable residual disease, cytogenetic remission, event-free survival, duration of response, and overall survival. The study also explores molecular markers that might predict response or resistance to treatment. Participants who qualify will take revumenib orally twice daily, about 12 hours apart, during each 28-day treatment cycle. The study focuses on relapsed or refractory acute leukemia of various lineages with specific genetic alterations associated with HOX gene upregulation. The treatment continues in cycles, with ongoing monitoring to assess effectiveness and safety. During the study, participants will be closely monitored for safety and adverse events, with an average follow-up of about one year. Researchers will conduct assessments including blood tests and other evaluations to track response and side effects. Participants or their guardians must provide informed consent, and the study collects data on molecular and cellular markers to understand treatment response better over the course of participation.
CONDITIONS
Brief 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 and weight at least 40 kg
- ECOG performance status of 2 or less
- Relapsed or refractory acute leukemia (myeloid, lymphoid, or mixed) with specific genetic alterations linked to HOX gene upregulation
- White blood cell count below 25,000 per microliter at enrollment
- Baseline ejection fraction greater than 40%
- Adequate liver function (direct bilirubin less than 1.5 times upper limit of normal unless due to leukemia, AST and/or ALT less than 3 times upper limit of normal unless due to leukemia)
- Adequate kidney function with estimated glomerular filtration rate 60 mL/min or higher
- Willing and able to provide informed consent
- At least 14 days since prior treatment for non-rapidly proliferative disease or appropriate interval since prior therapy for rapidly proliferative disease
- Women of childbearing potential and males must agree to use contraception during the study and for 3 months after last treatment
You will not qualify if you...
- Any uncontrolled medical condition, laboratory abnormality, or psychiatric illness posing unacceptable risk
- Use of other chemotherapy or anti-leukemic agents except specified exceptions
- Severe gastrointestinal or metabolic conditions affecting oral drug absorption
- Concurrent active malignancy under treatment
- Known active hepatitis B, hepatitis C, or HIV infection
- Pregnant or breastfeeding females
- Active uncontrolled infection
- Certain serious cardiac events or conditions within 6 months prior to study entry
- QTc interval above specified limits
- Conditions or therapies that might interfere with participation or study results
- Clinically active central nervous system leukemia
- Use of systemic immunosuppressive therapy post-transplant at screening, with some exceptions
- Grade greater than 2 active acute graft-versus-host disease or moderate to severe chronic graft-versus-host disease of any severity
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.
screening and enrollment visit
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants take revumenib orally twice a day every day during each 28-day study cycle.
1 baseline visit and multiple follow-up visits during treatment cycles
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
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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