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NCT07211958Phase 3RECRUITING

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

Study Summary

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
Acute Myeloid Leukemias
Interventions / Drugs
RevumenibPlaceboIntensive Chemotherapy Regimen
View on ClinicalTrials.gov ↗
Sponsor
SNDX
Syndax Pharmaceuticals
Oncology
C64/100
Study Details
Enrollment468 participants
Primary Completion—
Lead SponsorSyndax Pharmaceuticals
Data Retrieved2026-04-11 04:27:50.896963+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 468 participants
Sponsor Catalyst Profile

Syndax Pharmaceuticals (SNDX) is the sponsoring company for this trial. BiotechSign currently grades this company C (64/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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