Actively Recruiting
Revumenib in Combination With 7+3 + Midostaurin in AML
Led by Richard Stone, MD · Updated on 2026-03-25
22
Participants Needed
2
Research Sites
168 weeks
Total Duration
On this page
Sponsors
R
Richard Stone, MD
Lead Sponsor
S
Syndax Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants with newly diagnosed Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML). The names of the study drugs involved in this study are: * Revumenib (SNDX-5613) (a type of menin inhibitor) * Midostaurin (a type of multi-kinase including FLT3 inhibitor) * Cytarabine (a type of antineoplastic agent) * Daunorubicin (a type of antineoplastic agent)
CONDITIONS
Official Title
Revumenib in Combination With 7+3 + Midostaurin in AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly diagnosed AML according to WHO 2022 Classification, previously untreated except for hydroxyurea or brief ATRA pretreatment
- Age 18 to less than 75 years
- ECOG performance status of 0 to 2
- Presence of FLT3-ITD and/or TKD mutation(s) AND NPM1 mutation in bone marrow or peripheral blood
- Dose escalation phase: presence of certain high-risk genetic features or mutations including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, ZRSR2, or mutated TP53
- Left ventricular ejection fraction (LVEF) at least 50%
- Adequate kidney function with creatinine clearance at least 60 mL/min
- Adequate liver function with AST and ALT less than or equal to 2.5 times upper limit of normal, and total bilirubin less than or equal to 1.5 times upper limit unless due to leukemia
- Resolution of prior drug therapy side effects to grade 1 or less
- Eligible for intensive 7+3 chemotherapy per physician opinion
- Male subjects agree to avoid unprotected sex and sperm donation from study start until 90 days after last dose
- Females of childbearing potential must have negative pregnancy test within 7 days before starting treatment
- Willing and able to provide informed consent
- Consolidation therapy between 1 to 4 weeks after count recovery following induction remission, with less than 5% blasts in bone marrow, ANC above 1000, platelet count above 75,000, good performance status, and resolved side effects to grade 1 or less
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia, inversion (16), or t(8;21) AML
- Known active central nervous system involvement with AML
- Use of strong CYP3A4 inducers within 7 days before starting study treatment
- Use of strong CYP3A4 inhibitors except certain antifungal azole medications
- QTc interval greater than 450 msec on ECG
- Positive HIV test
- Positive hepatitis B or C infection unless viral load undetectable within 3 months
- Consumption of grapefruit, Seville oranges, or star fruit within 3 days before treatment
- New York Heart Association Class 2 or higher cardiovascular disability
- Significant medical conditions that may affect participation, including renal, neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic, or cardiovascular diseases
- Chronic respiratory disease requiring continuous oxygen
- Malabsorption syndrome or conditions preventing oral medication
- Other uncontrolled significant conditions including infections
- History of other cancers except certain adequately treated or disease-free malignancies for at least 2 years
- Treatment with chemotherapy, immunotherapy, or investigational agents within 1 month before enrollment
- Prior exposure to a menin inhibitor
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Yale Cancer Center
New Haven, Connecticut, United States, 06150
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
R
Richard Stone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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