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RECRUITING
NCT07211958
PHASE3

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

Sponsor: Syndax Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

Revumenib

Participants will receive revumenib orally.

DRUG

Placebo

Participants will receive placebo (non-active agent) orally.

DRUG

Intensive Chemotherapy Regimen

Participants will receive an intensive chemotherapy regimen of cytarabine and daunorubicin by intravenous (IV) infusion.

Locations (109)

Clinical Trial Site

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

Clinical Trial Site 2

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