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OncoMatch/Clinical Trials/NCT07211958

Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation

Is NCT07211958 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Revumenib and Intensive Chemotherapy Regimen for acute myeloid leukemias.

Phase 3RecruitingSyndax PharmaceuticalsNCT07211958Data as of Jun 2026Location: Georgia · Israel · South Korea

Treatment: Revumenib · Intensive Chemotherapy RegimenThe purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Revumenib

Other

Intensive Chemotherapy Regimen

Biomarker criteria

Required: NPM1 mutation

Performance status

ECOG/KARNOFSKY/LANSKY 0–2

Eastern Cooperative Oncology Group performance status ≤2 (≤1 if >65 years old); Karnofsky or Lansky ≥40

Demographics

Ages ≥ 12

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Kidney function

adequate kidney function

Liver function

adequate liver function

Cardiac function

adequate cardiac function; Fridericia's corrected QT interval (QTcF) >450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome [excluded]

Adequate liver, kidney, and cardiac function. Fridericia's corrected QT interval (QTcF) >450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07211958 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 NPM1?

Yes, NPM1 mutation is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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