Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
← catalyst calendarNCT07211958 · readout ≤ 1,046 d
Sponsored by Syndax Pharmaceuticals (industry) · SNDX — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
468estimated
Sites
83
Countries
Australia, Austria, Belgium +13
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-11-25 | actual | When the study began enrolling |
| Primary completion | Jun 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2031 | estimated | The whole study's end, after follow-up |
| First posted | 2025-10-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Acute Myeloid Leukemias
Interventions
- Drug: Revumenib — also filed as SNDX-5613
- Drug: Placebo
- Drug: Intensive Chemotherapy Regimen
Primary outcomes
what the primary-completion date above is the date OFEvent Free Survival
measured Up to 2 years
Measurable Residual Disease Complete Remission Rate
measured Up to 2 years
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