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New drug combo aims to beat tough leukemia

NCT ID NCT07211958

Disease control Sponsor: Syndax Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether adding the drug revumenib to standard intensive chemotherapy helps people with newly diagnosed acute myeloid leukemia (AML) that has a specific genetic change (NPM1 mutation). About 468 participants will receive either revumenib or a placebo along with chemotherapy. The study looks at how long people live without their cancer getting worse and if the cancer becomes undetectable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
revumenib
What this could lead to
If it works, this could lead to a new treatment option that improves survival and reduces cancer cells for people with this type of AML.
What could go wrong
This is a large phase 3 trial, but it's still experimental. Adding revumenib may not improve outcomes and could cause additional side effects. Results are not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 468 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia with mutated NPM1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemias

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    109 sites in 19 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Clinical Trial Site

    RECRUITING

    Goodyear, Arizona, 85338, United States

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    Duarte, California, 91010, United States

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    Shreveport, Louisiana, 71103, United States

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    South Brisbane, Queensland, 4101, Australia

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    Melbourne, Victoria, 3004, Australia

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    Nedlands, Western Australia, 6009, Australia

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    Perth, Western Australia, 6000, Australia

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    Gosford, 2250, Australia

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    Wollongong, 2500, Australia

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    Klagenfurt, Kaerten, 9020, Austria

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    Sankt Pölten, Lower Austria, 3100, Austria

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    Graz, Styria, 8036, Austria

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    Leoben, Styria, 8700, Austria

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    Linz, 4030, Austria

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    Ghent, 9000, Belgium

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    Fortaleza, Paraná, 60430-372, Brazil

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    Barretos, São Paulo, 14784-400, Brazil

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    Jaú, 17210-080, Brazil

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    Porto Alegre, 90610-910, Brazil

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    Montreal, H1T 2M4, Canada

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    Toronto, M5G 2C1, Canada

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    Nice, Alpes-Maritimes, 06200, France

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    Strasbourg, Bas-Rhin, 67098, France

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    Angers, Loire-Atlantique, 44093, France

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    Pessac, Pas-de-Calais, 33608, France

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    Bayonne, 64100, France

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    Batumi, Adjara, 6000, Georgia

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    Tbilisi, 0112, Georgia

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    Tbilisi, 0186, Georgia

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    Heidelberg, Baden-Wurttemberg, 69120, Germany

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    Tübingen, Baden-Wurttemberg, 72076, Germany

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    Düsseldorf, North Rhine-Westphalia, 40479, Germany

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    Herne, North Rhine-Westphalia, 44625, Germany

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    Jena, Thuringia, 07747, Germany

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    Hamburg, 20251, Germany

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    Patras, North Aegean, 26504, Greece

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    Győr, Gyor-Moson-Sopron Varmegye, H-9024, Hungary

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    Budapest, 1088, Hungary

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    Petah Tikva, Central District, 4941492, Israel

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    Jerusalem, Jerusalem, 9124001, Israel

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    Tel Aviv, Tel Aviv, 6423906, Israel

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    Haifa, 3109601, Israel

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    Jerusalem, 91031, Israel

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    Jerusalem, 91120, Israel

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    Monza, Monza E Brianza, 20900, Italy

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    Pesaro, Pesaro E Urbino, 61122, Italy

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    Alessandria, 15121, Italy

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    Bergamo, 24127, Italy

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    Bologna, 40138, Italy

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    Brescia, 25123, Italy

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    Candiolo, 10060, Italy

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    Florence, 50134, Italy

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    Meldola, 47014, Italy

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    Milan, 20132, Italy

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    Milan, 20141, Italy

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    Milan, 20162, Italy

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    Palermo, 90146, Italy

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    Pavia, 27100, Italy

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    Perugia, 06132, Italy

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    Pisa, 56126, Italy

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    Reggio Emilia, 42123, Italy

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    Rimini, 47923, Italy

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    Roma, 00168, Italy

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    Torino, 10128, Italy

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    Udine, 33100, Italy

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    Vilnius, 08661, Lithuania

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    Johor Bahru, Johor, 80000, Malaysia

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    Petaling Jaya, 46050, Malaysia

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    Subang Jaya, 46150, Malaysia

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    Târgu Mureş, Mureș County, 540136, Romania

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    Bucharest, 020125, Romania

  • Clinical Trial Site

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    Bucharest, 030171, Romania

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    Cluj-Napoca, 400015, Romania

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    Iași, 700483, Romania

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

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

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

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    Busan, 48108, South Korea

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    Goyang-si, 10408, South Korea

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    Seoul, 03080, South Korea

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    Seoul, 06591, South Korea

  • Clinical Trial Site

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    Badalona, Barcelona, 08916, Spain

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    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

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    Las Palmas de Gran Canaria, Canary Islands, 35010, Spain

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    Oviedo, Principality of Asturias, 33011, Spain

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    Alicante, 03010, Spain

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    Barcelona, 08036, Spain

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    Burgos, 09006, Spain

  • Clinical Trial Site

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    Cáceres, 10003, Spain

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    Granada, 18014, Spain

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    Madrid, 28007, Spain

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    Madrid, 28009, Spain

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    Madrid, 28033, Spain

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    Madrid, 28034, Spain

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    Málaga, 29010, Spain

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    Palma, 07120, Spain

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    Pamplona, 31008, Spain

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    Salamanca, 37007, Spain

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    Seville, 41013, Spain

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    Valencia, 46026, Spain

  • Clinical Trial Site

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    Oxford, Oxfordshire, OX3 7LJ, United Kingdom

  • Clinical Trial Site

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    Aberdeen, AB25 2ZN, United Kingdom

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    Derby, DE22 3NE, United Kingdom

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    Lincoln, LN2 5QY, United Kingdom

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    London, W12 0HS, United Kingdom

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    Southampton, SO16 6YD, United Kingdom

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    Sutton, SM2 5PT, United Kingdom

  • Clinical Trial Site 1

    RECRUITING

    Tbilisi, 0159, Georgia

  • Clinical Trial Site 2

    RECRUITING

    Tbilisi, 0159, Georgia

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