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New hope for Hard-to-Treat leukemia: targeted pill combined with chemotherapy enters human trials

NCT ID NCT06226571

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 17, 2026 · Updated 4 times

Summary

This early-stage trial is testing a new oral drug called SNDX-5613 alongside standard intensive chemotherapy in people newly diagnosed with acute myeloid leukemia (AML) that has specific genetic changes (KMT2A, NPM1, or NUP98). The study aims to see if the combination is safe and tolerable, and how well it works. About 76 participants will receive the drug during induction, consolidation, and maintenance phases of treatment.

What this could mean

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

Active substance
SNDX-5613 (a targeted cancer pill) combined with standard chemotherapy drugs (cytarabine, daunorubicin or idarubicin)
What this could lead to
If successful, this could lead to a new treatment option for certain genetic types of AML that are hard to treat.
What could go wrong
This is an early Phase 1 trial with only 76 people, so safety and effectiveness are not yet proven. Side effects from the drug combination are unknown.
Why investors are watching

Syndax Pharmaceuticals runs a phase 1 trial of revumenib combined with intensive chemotherapy in people newly diagnosed with AML whose cancer carries KMT2A, NPM1, or NUP98 gene alterations. The trial tests safety, tolerability, and clinical activity in 96 participants. For a small company, a readout here matters because it points to whether revumenib can move into newly diagnosed patients, a larger group than the relapsed or refractory settings the drug was first studied in.

If it works: A positive result could support advancing revumenib into larger trials for newly diagnosed AML, which may broaden the patient population the drug can reach. That could make the program more valuable to partners or acquirers.

If it fails: Combining revumenib with intensive chemotherapy may cause side effects that limit dosing or stop the trial. Phase 1 trials often fail or produce unclear results, and any delay or setback could hurt a small company that depends on a limited pipeline.

AI-written from the trial record. Speculative, and not investment advice.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

96 people

The number who actually took part.

Started

May 2024

Expected to finish

Feb 2027

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

18 to 75 years

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.

Inclusion Criteria: * Established, pathologically confirmed diagnosis of AML by World Health Organization 2022 criteria. * Newly diagnosed and previously untreated AML and eligible to receive intensive chemotherapy. * KMT2Ar, NPM1m, or NUP98r mutations identified by local laboratory prior to the first dose of revumenib. * Eastern Cooperative Oncology Group performance status ≤2 and ≤1 if \>65 years old. * Adequate liver, kidney, and cardiac function. Exclusion Criteria: * Diagnosis of acute promyelocytic leukemia. * Clinically active central nervous system leukemia (blasts detected in cerebrospinal fluid, radiographic or clinical signs and symptoms). * Fridericia's corrected QT interval (QTcF) \>450 milliseconds (average of triplicate), diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome. * Any gastrointestinal issue of the upper gastrointestinal tract that might affect oral drug absorption or ingestion. * Cirrhosis with a Child-Pugh score of B or C. * Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack. * Hepatitis B, Hepatitis C, or HIV-positive with detectable viral load. * Documented active, uncontrolled infection. * Uncontrolled disseminated intravascular coagulation. * Lactating/breast feeding or pregnant. * Use of prohibited concomitant chemotherapy, radiation therapy, or immunotherapy. * Use of strong CYP3A4 inducers or inhibitors (except for Itraconazole, Ketoconazole, Posaconazole, or Voriconazole).

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia with mutated NPM1 acute myeloid leukemia, MLL gene rearrangement

As listed by the trial registrant

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

Acute myeloid leukemias

Contacts and locations

Locations

  • AdventHealth Blood & Marrow Transplant Center

    Orlando, Florida, 32804, United States

  • Allina Health Cancer Institute

    Minneapolis, Minnesota, 55407, United States

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • City of Hope

    Goodyear, Arizona, 85338, United States

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • East Carolina University

    Greenville, North Carolina, 27834, United States

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Gordon and Leslie Diamond Health Care Center

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Hammersmith Hospital

    London, London, City of, W12 0HS, United Kingdom

  • Hospital Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital San Pedro de Alcantara

    Cáceres, 10003, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario De Salamanca

    Salamanca, 37007, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013, Spain

  • Institution name: Northwell Health-Brany

    Lake Success, New York, 11042, United States

  • LDS Hospital - Intermountain Healthcare

    Salt Lake City, Utah, 84143, United States

  • MUSC Hollings Cancer Center (HCC)

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Northern Hospital, Victoria

    Epping, Victoria, 3076, Australia

  • Norton Cancer Institute, St. Matthews Campus

    Louisville, Kentucky, 40207, United States

  • Oregon Health and Science University- Center for Hematologic Malignancies

    Portland, Oregon, 97239, United States

  • Royal Adelaide Hospital

    Adelaide, SA 5000, Australia

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Sir Charles Gairdner Hospital

    Nedlands, 6009, Australia

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The Alfred Hospital, Victoria

    Melbourne, 3004, Australia

  • The Royal Marsden NHS

    Sutton, SM2 5PT, United Kingdom

  • The Sir Mortimer B. Davis Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCLA Medical Hematology

    Burbank, California, 91505, United States

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • Universitat de Valencia

    Valencia, 46026, Spain

  • University Medical Center Utrecht

    Utrecht, 3584, Netherlands

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Illinois

    Chicago, Illinois, 60612, United States

  • University of Louisville Health Brown Cancer Center

    Louisville, Kentucky, 40202, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.