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Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
Sponsor: Syndax Pharmaceuticals
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.
Official title: 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
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
468
Start Date
2025-11-25
Completion Date
2031-01
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Revumenib
Participants will receive revumenib orally.
Placebo
Participants will receive placebo (non-active agent) orally.
Intensive Chemotherapy Regimen
Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.
Locations (173)
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Goodyear, Arizona, United States
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Duarte, California, United States
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Farmington, Connecticut, United States
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Tampa, Florida, United States
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Indianapolis, Indiana, United States
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Shreveport, Louisiana, United States
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Morristown, New Jersey, United States
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Chapel Hill, North Carolina, United States
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Providence, Rhode Island, United States
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Greenville, South Carolina, United States
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Houston, Texas, United States
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Adrogué, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Córdoba, Córdoba Province, Argentina
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Buenos Aires, Argentina
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Salta, Argentina
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Kingswood, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Randwick, New South Wales, Australia
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Douglas, Queensland, Australia
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South Brisbane, Queensland, Australia
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Gosford, Australia
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Wollongong, Australia
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Klagenfurt, Kaerten, Austria
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Sankt Pölten, Lower Austria, Austria
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Graz, Styria, Austria
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Leoben, Styria, Austria
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Innsbruck, Tyrol, Austria
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Linz, Austria
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Vienna, Austria
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Ghent, Belgium
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São Paulo, Estado de Bahia, Brazil
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Fortaleza, Paraná, Brazil
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Barretos, São Paulo, Brazil
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Jaú, Brazil
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Porto Alegre, Brazil
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London, Ontario, Canada
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Montreal, Canada
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Toronto, Canada
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Nice, Alpes-Maritimes, France
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Strasbourg, Bas-Rhin, France
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Marseille, Bouches-Du-Rhône, France
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Caen, Calvados, France
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Rouen, Haute-Normandie, France
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Limoges, Haute-Vienne, France
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Angers, Loire-Atlantique, France
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Lille, Nord, France
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Pessac, Pas-de-Calais, France
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Pierre-Bénite, Rhône, France
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Le Chesnay, Yvelines, France
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Bayonne, France
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Paris, France
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Batumi, Adjara, Georgia
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Tbilisi, Georgia
Clinical Trial Site 1
Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Heidelberg, Baden-Wurttemberg, Germany
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Stuttgart, Baden-Wurttemberg, Germany
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Tübingen, Baden-Wurttemberg, Germany
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Braunschweig, Lower Saxony, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Herne, North Rhine-Westphalia, Germany
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Minden, North Rhine-Westphalia, Germany
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Chemnitz, Saxony, Germany
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Leipzig, Saxony, Germany
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Jena, Thuringia, Germany
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Hamburg, Germany
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Athens, Attica, Greece
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Patras, North Aegean, Greece
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Győr, Gyor-Moson-Sopron Varmegye, Hungary
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Debrecen, Hajdú-Bihar, Hungary
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Szekszárd, Tolna County, Hungary
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Budapest, Hungary
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Petah Tikva, Central District, Israel
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Jerusalem, Jerusalem, Israel
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Tel Aviv, Tel Aviv, Israel
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Tel Litwinsky, Tel Aviv, Israel
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Haifa, Israel
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Jerusalem, Israel
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Jerusalem, Israel
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Monza, Monza E Brianza, Italy
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Pesaro, Pesaro E Urbino, Italy
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Alessandria, Italy
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Bari, Italy
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Bergamo, Italy
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Bologna, Italy
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Brescia, Italy
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Candiolo, Italy
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Florence, Italy
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Meldola, Italy
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Milan, Italy
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Milan, Italy
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Milan, Italy
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Naples, Italy
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Palermo, Italy