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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Georgia
Clinical Trial Site
RECRUITING
Batumi
Clinical Trial Site
RECRUITING
Tbilisi
Clinical Trial Site
RECRUITING
Tbilisi
Republic of Korea
Clinical Trial Site
RECRUITING
Seoul
Clinical Trial Site
RECRUITING
Seoul
Contact Information
Primary
Syndax Pharmaceuticals
clinicaltrials@syndax.com
781-419-1400
Time Frame
Start Date: 2025-11-25
Estimated Completion Date: 2031-01
Participants
Target number of participants: 468
Treatments
Experimental: Revumenib + Intensive Chemotherapy
Participants will receive revumenib plus an intensive chemotherapy regimen.
Placebo_comparator: Placebo + Intensive Chemotherapy
Participants will receive placebo plus an intensive chemotherapy regimen.
Related Therapeutic Areas
Sponsors
Leads: Syndax Pharmaceuticals