OncoMatch/Clinical Trials/NCT06313437
Revumenib in Combination With 7+3 + Midostaurin in AML
Is NCT06313437 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Revumenib and Midostaurin for acute myeloid leukemia.
Treatment: Revumenib · Midostaurin · Cytarabine · Daunorubicin — 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: ASXL1 mutation
Required: BCOR mutation
Required: BCR fusion
Required: DEK fusion
Required: DNMT3A mutation
Required: EZH2 mutation
Required: FLT3 itd
Required: FLT3 itd
Required: FLT3 tkd
Required: GATA2 rearrangement
Required: KAT6A fusion
Required: KMT2A (MLL) rearrangement
Required: MECOM rearrangement
Required: NPM1 mutation
Required: NPM1 mutation
Required: RUNX1 mutation
Required: SF3B1 mutation
Required: SRSF2 mutation
Required: STAG2 mutation
Required: TP53 mutation
Required: U2AF1 mutation
Required: ZRSR2 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: menin inhibitor
Lab requirements
Kidney function
calculated creatinine clearance ≥ 60 ml/min; determined by the cockcroft gault formula
Liver function
ast ≤ 2.5 × uln, alt ≤ 2.5× uln, total bilirubin ≤ 1.5 × uln (unless considered due to leukemic organ involvement or gilbert's syndrome)
Cardiac function
lvef ≥ 50% by muga or echo at screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale Cancer Center · New Haven, Connecticut
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06313437 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ASXL1?
Yes, ASXL1 mutation is a required biomarker for enrollment.
Does this trial require BCOR?
Yes, BCOR mutation is a required biomarker for enrollment.
Does this trial require BCR?
Yes, BCR fusion is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify