OncoMatch/Clinical Trials/NCT06313437
Revumenib in Combination With 7+3 + Midostaurin in AML
Is NCT06313437 recruiting? Yes, currently enrolling (May 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
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic 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)
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 →
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