At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Revumenib (drug), Placebo (drug), Intensive Chemotherapy Regimen (drug)
- How long the study runs
- Study runs about 62 months (dates as stated)
- About the drug or intervention
- Revumenib — drug: Participants will receive revumenib orally. · Placebo — drug: Participants will receive placebo (non-active agent) orally. · Intensive Chemotherapy Regimen — drug: Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 12 Years and over
- Who
- All
- Number of participants
- 468
- Started
- 2025-11-25
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for acute myeloid leukemias
- • Phase3 - 468 participants
- • 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
Who can take part?
- • Ages 12 Years and over
- • Diagnosed with acute myeloid leukemias
Where?
- • Oxford - Clinical Trial Site
- • Aberdeen - Clinical Trial Site
- • Derby - Clinical Trial Site
- • Lincoln - Clinical Trial Site
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy
What the study is looking for
- ✓Participants must have newly diagnosed and previously untreated AML and be candidates for intensive drug treatment.
- ✓Presence of an NPM1 mutation.
- ✓activity scale performance status ≤2 (≤1 if \>65 years old); Karnofsky or Lansky ≥40.
- ✓Have a expected to live at least 3 $2 as judged by the Investigator.
- ✓Negative serum pregnancy test.
Who cannot take part
- ✗Diagnosis of active acute promyelocytic leukemia.
- ✗Active central nervous system disease.
- ✗Fridericia's corrected QT interval (QTcF) \>450 milliseconds at screening, diagnosis or suspicion of Long QT...
- ✗Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion.
- ✗Any concurrent cancer requiring active therapy (except breast or prostate cancer stable on or responding to...
See the full criteria
Where Is This Study? (7 UK sites)
Clinical Trial Site
Oxford OX3 7LJ, United Kingdom
Clinical Trial Site
Aberdeen AB25 2ZN, United Kingdom
Clinical Trial Site
Derby DE22 3NE, United Kingdom
Clinical Trial Site
Lincoln LN2 5QY, United Kingdom
Clinical Trial Site
London W12 0HS, United Kingdom
Clinical Trial Site
Southampton SO16 6YD, United Kingdom
Clinical Trial Site
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Syndax Pharmaceuticals
Sponsor contactCONTACT
