Skip to main content
Back to Trials
NCT07211958PHASE3Recruiting

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

Syndax Pharmaceuticals

Start Date

11/25/2025

Completion Date

1/1/2031

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 Criteria

Age Range: 12 years to No maximum

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * Diagnosis of active acute promyelocytic leukemia. * Active central nervous system disease. * Fridericia's corrected QT interval (QTcF) \>450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome. * Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion. * Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy). * Inability to swallow oral medication. * Pregnant or nursing females. * Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load. Note: Additional inclusion/exclusion criteria may apply, per protocol.

Interventions

DRUG

Revumenib

DRUG

Placebo

DRUG

Intensive Chemotherapy Regimen

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Acute Myeloid Leukemias

Locations

Clinical Trial Site

Goodyear, Arizona 85338

United States

Clinical Trial Site

Duarte, California 91010

United States

Clinical Trial Site

Indianapolis, Indiana 46237

United States

Clinical Trial Site

Shreveport, Louisiana 71103

United States

Clinical Trial Site

Providence, Rhode Island 02903

United States

Clinical Trial Site

Houston, Texas 77030

United States

Clinical Trial Site

Adrogué, Buenos Aires C1430EFA

Argentina

Clinical Trial Site

Córdoba, Córdoba Province X5000

Argentina

Clinical Trial Site

Buenos Aires, C1039

Argentina

Clinical Trial Site

Salta, A4400

Argentina

Clinical Trial Site

Kingswood, New South Wales 2747

Australia

Clinical Trial Site

Kogarah, New South Wales 2217

Australia

Clinical Trial Site

Randwick, New South Wales 2031

Australia

Clinical Trial Site

South Brisbane, Queensland 4101

Australia

Clinical Trial Site

Melbourne, Victoria 3004

Australia

Clinical Trial Site

Nedlands, Western Australia 6009

Australia

Clinical Trial Site

Perth, Western Australia 6000

Australia

Clinical Trial Site

Gosford, 2250

Australia

Clinical Trial Site

Wollongong, 2500

Australia

Clinical Trial Site

Klagenfurt, Kaerten 9020

Austria

Clinical Trial Site

Sankt Pölten, Lower Austria 3100

Austria

Clinical Trial Site

Graz, Styria 8036

Austria

Clinical Trial Site

Leoben, Styria 8700

Austria

Clinical Trial Site

Innsbruck, Tyrol 6020

Austria

Clinical Trial Site

Linz, 4030

Austria

Clinical Trial Site

Vienna, 1100

Austria

Clinical Trial Site

Ghent, 9000

Belgium

Clinical Trial Site

São Paulo, Estado de Bahia 05651-901

Brazil

Clinical Trial Site

Fortaleza, Paraná 60430-372

Brazil

Clinical Trial Site

Barretos, São Paulo 14784-400

Brazil

Clinical Trial Site

Jaú, 17210-080

Brazil

Clinical Trial Site

Porto Alegre, 90610-910

Brazil

Clinical Trial Site

London, Ontario N6A 5W9

Canada

Clinical Trial Site

Montreal, H1T 2M4

Canada

Clinical Trial Site

Toronto, M5G 2C1

Canada

Clinical Trial Site

Nice, Alpes-Maritimes 06200

France

Clinical Trial Site

Strasbourg, Bas-Rhin 67098

France

Clinical Trial Site

Marseille, Bouches-Du-Rhône 13009

France

Clinical Trial Site

Caen, Calvados 14033 Cedex

France

Clinical Trial Site

Rouen, Haute-Normandie 76000

France

Clinical Trial Site

Limoges, Haute-Vienne 87042

France

Clinical Trial Site

Angers, Loire-Atlantique 44093

France

Clinical Trial Site

Lille, Nord 59037

France

Clinical Trial Site

Pessac, Pas-de-Calais 33608

France

Clinical Trial Site

Bayonne, 64100

France

Clinical Trial Site

Paris, 75012

France

Clinical Trial Site

Batumi, Adjara 6000

Georgia

Clinical Trial Site

Tbilisi, 0112

Georgia

Clinical Trial Site 1

Tbilisi, 0159

Georgia

Clinical Trial Site 2

Tbilisi, 0159

Georgia

Clinical Trial Site

Tbilisi, 0186

Georgia

Clinical Trial Site

Heidelberg, Baden-Wurttemberg 69120

Germany

Clinical Trial Site

Stuttgart, Baden-Wurttemberg 70376

Germany

Clinical Trial Site

Tübingen, Baden-Wurttemberg 72076

Germany

Clinical Trial Site

Düsseldorf, North Rhine-Westphalia 40479

Germany

Clinical Trial Site

Herne, North Rhine-Westphalia 44625

Germany

Clinical Trial Site

Minden, North Rhine-Westphalia 32429

Germany

Clinical Trial Site

Chemnitz, Saxony 09116

Germany

Clinical Trial Site

Jena, Thuringia 07747

Germany

Clinical Trial Site

Hamburg, 20251

Germany

Clinical Trial Site

Athens, Attica 124 62

Greece

Clinical Trial Site

Patras, North Aegean 26504

Greece

Clinical Trial Site

Győr, Gyor-Moson-Sopron Varmegye H-9024

Hungary

Clinical Trial Site

Budapest, 1088

Hungary

Clinical Trial Site

Petah Tikva, Central District 4941492

Israel

Clinical Trial Site

Jerusalem, Jerusalem 9124001

Israel

Clinical Trial Site

Tel Aviv, Tel Aviv 6423906

Israel

Clinical Trial Site

Tel Litwinsky, Tel Aviv 5265601

Israel

Clinical Trial Site

Haifa, 3109601

Israel

Clinical Trial Site

Jerusalem, 91031

Israel

Clinical Trial Site

Jerusalem, 91120

Israel

Clinical Trial Site

Monza, Monza E Brianza 20900

Italy

Clinical Trial Site

Pesaro, Pesaro E Urbino 61122

Italy

Clinical Trial Site

Alessandria, 15121

Italy

Clinical Trial Site

Bergamo, 24127

Italy

Clinical Trial Site

Bologna, 40138

Italy

Clinical Trial Site

Brescia, 25123

Italy

Clinical Trial Site

Candiolo, 10060

Italy

Clinical Trial Site

Florence, 50134

Italy

Clinical Trial Site

Meldola, 47014

Italy

Clinical Trial Site

Milan, 20132

Italy

Clinical Trial Site

Milan, 20141

Italy

Clinical Trial Site

Milan, 20162

Italy

Clinical Trial Site

Palermo, 90146

Italy

Clinical Trial Site

Pavia, 27100

Italy

Clinical Trial Site

Perugia, 06132

Italy

Clinical Trial Site

Pisa, 56126

Italy

Clinical Trial Site

Reggio Emilia, 42123

Italy

Clinical Trial Site

Rimini, 47923

Italy

Clinical Trial Site

Roma, 00165

Italy

Clinical Trial Site

Roma, 00168

Italy

Clinical Trial Site

Torino, 10128

Italy

Clinical Trial Site

Udine, 33100

Italy

Clinical Trial Site

Vilnius, 08661

Lithuania

Clinical Trial Site

Johor Bahru, Johor 80000

Malaysia

Clinical Trial Site

Kuala Lumpur, 59100

Malaysia

Clinical Trial Site

Petaling Jaya, 46050

Malaysia

Clinical Trial Site

Subang Jaya, 46150

Malaysia

Clinical Trial Site

Wałbrzych, Kuyavian-Pomeranian Voivodeship 58-309

Poland

Clinical Trial Site

Opole, Opole Voivodeship 45-061

Poland

Clinical Trial Site

Olsztyn, Warmian-Masurian Voivodeship 10-228

Poland

Clinical Trial Site

Târgu Mureş, Mureș County 540136

Romania

Clinical Trial Site

Bucharest, 020125

Romania

Clinical Trial Site

Bucharest, 030171

Romania

Clinical Trial Site

Cluj-Napoca, 400015

Romania

Clinical Trial Site

Iași, 700483

Romania

Clinical Trial Site

Singapore, Central Singapore 169608

Singapore

Clinical Trial Site

Busan, Busan Gwang'yeogsi [Pusan-Kwangyokshi] 49201

South Korea

Clinical Trial Site

Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi] 41944

South Korea

Clinical Trial Site

Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi] 42472

South Korea

Clinical Trial Site

Busan, 48108

South Korea

Clinical Trial Site

Goyang-si, 10408

South Korea

Clinical Trial Site

Seoul, 03080

South Korea

Clinical Trial Site

Seoul, 06591

South Korea

Clinical Trial Site

Badalona, Barcelona 08916

Spain

Clinical Trial Site

L'Hospitalet de Llobregat, Barcelona 08908

Spain

Clinical Trial Site

Las Palmas de Gran Canaria, Canary Islands 35010

Spain

Clinical Trial Site

Santander, Cantabria 39008

Spain

Clinical Trial Site

Oviedo, Principality of Asturias 33011

Spain

Clinical Trial Site

Alicante, 03010

Spain

Clinical Trial Site

Barcelona, 08036

Spain

Clinical Trial Site

Barcelona, 08041

Spain

Clinical Trial Site

Burgos, 09006

Spain

Clinical Trial Site

Cáceres, 10003

Spain

Clinical Trial Site

Granada, 18014

Spain

Clinical Trial Site

Madrid, 28007

Spain

Clinical Trial Site

Madrid, 28009

Spain

Clinical Trial Site

Madrid, 28033

Spain

Clinical Trial Site

Madrid, 28034

Spain

Clinical Trial Site

Madrid, 28040

Spain

Clinical Trial Site

Madrid, 28046

Spain

Clinical Trial Site

Málaga, 29010

Spain

Clinical Trial Site

Palma, 07120

Spain

Clinical Trial Site

Pamplona, 31008

Spain

Clinical Trial Site

Salamanca, 37007

Spain

Clinical Trial Site

Seville, 41013

Spain

Clinical Trial Site

Valencia, 46026

Spain

Clinical Trial Site

Şişli, Istanbul 34385

Turkey (Türkiye)

Clinical Trial Site

Mezitli, Mersin 33200

Turkey (Türkiye)

Clinical Trial Site

Ankara, 06100

Turkey (Türkiye)

Clinical Trial Site

Antalya, 07025

Turkey (Türkiye)

Clinical Trial Site

Gaziantep, 27080

Turkey (Türkiye)

Clinical Trial Site

Oxford, Oxfordshire OX3 7LJ

United Kingdom

Clinical Trial Site

Aberdeen, AB25 2ZN

United Kingdom

Clinical Trial Site

Derby, DE22 3NE

United Kingdom

Clinical Trial Site

Lincoln, LN2 5QY

United Kingdom

Clinical Trial Site

London, W12 0HS

United Kingdom

Clinical Trial Site

Southampton, SO16 6YD

United Kingdom

Clinical Trial Site

Sutton, SM2 5PT

United Kingdom