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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
2026-08-28
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 (109)
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Goodyear, Arizona, United States
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Duarte, California, United States
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Shreveport, Louisiana, United States
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South Brisbane, Queensland, Australia
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Melbourne, 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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Linz, Austria
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Ghent, Belgium
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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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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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Angers, Loire-Atlantique, France
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Pessac, Pas-de-Calais, France
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Bayonne, 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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Tübingen, Baden-Wurttemberg, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Herne, North Rhine-Westphalia, Germany
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Jena, Thuringia, Germany
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Hamburg, Germany
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Patras, North Aegean, Greece
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Győr, Gyor-Moson-Sopron Varmegye, 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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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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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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Palermo, Italy
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Pavia, Italy
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Perugia, Italy
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Pisa, Italy
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Reggio Emilia, Italy
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Rimini, Italy
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Roma, Italy
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Torino, Italy
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Udine, Italy
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Vilnius, Lithuania
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Johor Bahru, Johor, Malaysia
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Petaling Jaya, Malaysia
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Subang Jaya, Malaysia
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Târgu Mureş, Mureș County, Romania
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Bucharest, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Iași, Romania
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Busan, Busan Gwang'yeogsi [Pusan-Kwangyokshi], South Korea
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Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], South Korea
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Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], South Korea
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Busan, South Korea
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Goyang-si, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Badalona, Barcelona, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Las Palmas de Gran Canaria, Canary Islands, Spain
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Oviedo, Principality of Asturias, Spain
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Alicante, Spain
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Barcelona, Spain
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Burgos, Spain
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Cáceres, Spain
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Granada, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Málaga, Spain
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Palma, Spain
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Pamplona, Spain
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Salamanca, Spain
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Seville, Spain
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Valencia, Spain
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Oxford, Oxfordshire, United Kingdom
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Aberdeen, United Kingdom
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Derby, United Kingdom
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Lincoln, United Kingdom
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London, United Kingdom
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Southampton, United Kingdom
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Sutton, United Kingdom