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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.

Phase 1RecruitingRichard Stone, MDNCT06313437Data as of May 2026

Treatment: Revumenib · Midostaurin · Cytarabine · DaunorubicinThis 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)

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Extracted 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

No prior treatment (treatment-naive required)

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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