Actively Recruiting
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
Led by Syndax Pharmaceuticals · Updated on 2026-05-04
468
Participants Needed
14
Research Sites
266 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed and previously untreated AML and candidates for intensive chemotherapy
- Presence of an NPM1 mutation
- Eastern Cooperative Oncology Group performance status 2 or less (1 or less if over 65 years old); Karnofsky or Lansky score 40 or higher
- Life expectancy of at least 3 months as judged by the Investigator
- Negative serum pregnancy test
- Adequate liver, kidney, and heart function
You will not qualify if you...
- Diagnosis of active acute promyelocytic leukemia
- Active central nervous system disease
- QTcF greater than 450 milliseconds at screening or diagnosis, suspicion or family history of Long QT syndrome
- Upper gastrointestinal issues likely to affect oral drug absorption or swallowing
- Any other active cancer requiring treatment (except stable breast or prostate cancer on endocrine therapy)
- Inability to swallow oral medication
- Pregnant or nursing females
- Known active or chronic hepatitis B, active hepatitis C infection, or HIV-positive with detectable viral load
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Clinical Trial Site
Batumi, Adjara, Georgia, 6000
Actively Recruiting
2
Clinical Trial Site
Tbilisi, Georgia, 0112
Actively Recruiting
3
Clinical Trial Site 1
Tbilisi, Georgia, 0159
Actively Recruiting
4
Clinical Trial Site 2
Tbilisi, Georgia, 0159
Actively Recruiting
5
Clinical Trial Site
Tbilisi, Georgia, 0186
Actively Recruiting
6
Clinical Trial Site
Düsseldorf, North Rhine-Westphalia, Germany, 40479
Actively Recruiting
7
Clinical Trial Site
Jerusalem, Israel, 91031
Actively Recruiting
8
Clinical Trial Site
Candiolo, Italy, 10060
Actively Recruiting
9
Clinical Trial Site
Palermo, Italy, 90146
Actively Recruiting
10
Clinical Trial Site
Goyang-si, South Korea, 10408
Actively Recruiting
11
Clinical Trial Site
Seoul, South Korea, 03080
Actively Recruiting
12
Clinical Trial Site
Seoul, South Korea, 06591
Actively Recruiting
13
Clinical Trial Site
London, United Kingdom, W12 0HS
Actively Recruiting
14
Clinical Trial Site
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
S
Syndax Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here