Tests revumenib with chemotherapy for newly diagnosed acute myeloid leukemia with NPM1 mutation
Tests revumenib added to chemotherapy in people aged 12 and older with newly diagnosed AML.
Plain-language title generated from the registry record
Registry title: Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
Key facts
- Where
- Brno and Ostrava, CzechiaSee the 2 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with newly diagnosed acute myeloid leukemia (AML) who have an NPM1 gene mutation and can have intensive chemotherapy.
- Age
- 12 years and older.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML that has not been treated before, in people who can have intensive chemotherapy.
- Earlier treatment
- No earlier treatment for AML.
- Biomarker or test result
- An NPM1 mutation must be present.
Main reasons for not taking part
- Active acute promyelocytic leukemia
- Active central nervous system disease
- QTcF above 450 milliseconds, or Long QT syndrome or a family history of it
- Problems in the upper digestive tract that affect taking pills, or being unable to swallow pills
- Pregnant or nursing women
Read by machine on 11 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How old are you?
- Has your leukemia (AML) been treated yet? Please do not count hydroxyurea (a tablet that lowers white blood cell counts) or leukapheresis (a machine that filters extra white blood cells out of your blood).
- Has your doctor said you cannot have intensive chemotherapy (very strong chemotherapy given in hospital)?
- Has a lab test of your blood or bone marrow found one of these gene changes in your leukemia?
- Are you pregnant or breastfeeding?
- How old is the patient who may join a trial?
- What type of cancer has the patient been diagnosed with?
- Is the patient pregnant or breastfeeding?
Source: NCT07211958, who can take part
Where in Czechia
- Fakultni nemocnice BrnoBrno, CzechiaNot yet recruiting
- Fakultni nemocnice OstravaOstrava, CzechiaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Syndax Pharmaceuticals
- Trial code
- NCT07211958EU 2025-522279-27-00
- Record updated
- 21 October 2026
- Original description
The 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.Read full original descriptionShow less
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation
The 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.
Inclusion: Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy; Presence of an NPM1 mutation; Eastern Cooperative Oncology Group performance status ≤2 (≤1 if >65 years old); Karnofsky or Lansky ≥40; Have a life expectancy of ≥3 months as judged by the Investigator; Negative serum pregnancy test; Adequate liver, kidney, and cardiac function.
Exclusion: Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion; Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy); Inability to swallow oral medication; Active central nervous system disease; Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load; Note: Additional inclusion/exclusion criteria may apply, per protocol; Fridericia's corrected QT interval (QTcF) >450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome; Diagnosis of active acute promyelocytic leukemia; Pregnant or nursing females.