Acute Myeloid Leukemia (AML) Clinical Trials

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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 (109) 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
United States
Arizona
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Goodyear
California
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Duarte
Louisiana
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Shreveport
Other Locations
Australia
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Gosford
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Melbourne
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Nedlands
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Perth
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South Brisbane
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Wollongong
Austria
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Graz
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Klagenfurt
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Leoben
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Linz
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Sankt Pölten
Belgium
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Ghent
Brazil
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Barretos
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Fortaleza
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Jaú
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Porto Alegre
Canada
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Montreal
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Toronto
France
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Angers
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Bayonne
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Nice
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Pessac
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Strasbourg
Georgia
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Batumi
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Tbilisi
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Tbilisi
Clinical Trial Site 1
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Tbilisi
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Tbilisi
Germany
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Düsseldorf
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Hamburg
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Heidelberg
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Herne
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Jena
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Tübingen
Greece
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Patras
Hungary
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Budapest
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Győr
Israel
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Haifa
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Jerusalem
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Jerusalem
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Jerusalem
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Petah Tikva
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Tel Aviv
Italy
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Alessandria
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Bergamo
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Bologna
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Brescia
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Candiolo
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Florence
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Meldola
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Milan
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Milan
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Milan
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Monza
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Palermo
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Pavia
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Perugia
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Pesaro
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Pisa
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Reggio Emilia
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Rimini
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Roma
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Torino
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Udine
Lithuania
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Vilnius
Malaysia
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Johor Bahru
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Petaling Jaya
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Subang Jaya
Republic of Korea
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Busan
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Busan
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Daegu
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Daegu
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Goyang-si
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Seoul
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Seoul
Romania
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Bucharest
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Bucharest
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Cluj-napoca
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Iași
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Târgu Mureş
Spain
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Alicante
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Badalona
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Barcelona
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Burgos
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Cáceres
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Granada
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L'hospitalet De Llobregat
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Las Palmas De Gran Canaria
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Madrid
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Madrid
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Madrid
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Madrid
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Málaga
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Oviedo
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Palma
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Pamplona
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Salamanca
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Seville
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Valencia
United Kingdom
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Aberdeen
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Derby
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Lincoln
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London
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Oxford
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Southampton
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Sutton
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

This content was sourced from clinicaltrials.gov