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New combo therapy targets tough leukemia mutations

NCT ID NCT05453903

Disease control Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 3 times

Summary

This early-stage study tests a new drug called bleximenib combined with other leukemia treatments for people with acute myeloid leukemia (AML) that has specific genetic changes (KMT2A or NPM1). The main goals are to find the best dose and check for side effects. About 196 participants, including some teens, will take part.

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

196 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Mar 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

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.

Inclusion Criteria: * Adolescent participants (defined as greater than or equal to \[\>=\] 12 and less than \[\<\] 18 years of age) are only eligible for the relapsed/refractory (R/R) cohort (Arm A, cohort A4) * Diagnosis of AML according to World Health Organization (WHO) criteria: a) De novo or secondary AML; b) relapsed/refractory (Arm A only); c) harboring KMT2A, NPM1, NUP98, or NUP214 alterations; d) Participants may receive emergency leukapheresis and/or cytarabine as cytoreductive therapy according to local practice guidelines * Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to (\<=) 25\*10\^9 per liter (/L), adequate liver and renal function * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Adolescent participants only: Performance status \>70 by Lansky scale (for participants \<16 years of age) or \>70 Karnofsky scale (for participants \>16 years of age) * A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment * Must sign an informed consent form (ICF) indicating participant (or their legally authorized representative) understands the purpose of the study and procedures required for the study and is willing to participate in the study * Willing and able to adhere to the prohibitions and restrictions specified in this protocol Exclusion Criteria: * Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to WHO 2016 criteria * Leukemic involvement of the central nervous system * Recipient of solid organ transplant * Cardiovascular disease that is uncontrolled, increases risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment including, but not limited to: (a) Myocardial infarction; (b) Severe or unstable angina; (c) Clinically significant cardiac arrhythmias, including bradycardia (\<50 beats per minute); (d) Uncontrolled (persistent) hypertension: (example, blood pressure greater than \[\>\] 140/90 millimeters of mercury \[mm Hg\]; (e) Acute neurologic events such as stroke or transient ischemic attack, intracranial or subarachnoid hemorrhage, intracranial trauma; (f) Venous thromboembolic events (example, pulmonary embolism) within 1 month prior to the first dose of study treatment ;(g) Congestive heart failure (NYHA class III to IV); (h) Pericarditis or clinically significant pericardial effusion; (i) Myocarditis; (j) Endocarditis (k) Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected for hypoalbuminemia) * Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less * Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation * Participants with diagnosis of Fanconi anemia, Kostmann syndrome, Shwachman diamond syndrome, or any other known bone marrow failure syndrome

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

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

Leukemia, myeloid, acute

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Albert Einstein College Of Medicine

    New York, New York, 10461, United States

  • Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

    Bologna, 40138, Italy

  • CHU de Tours - Hôpital de Bretonneau

    Tours, 37044, France

  • Charite Universitaetsmedizin Berlin

    Berlin, 13353, Germany

  • Christie Hospital NHS Trust

    Manchester, M20 4BX, United Kingdom

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35033, France

  • City of Hope

    Duarte, California, 91010, United States

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 8035, Spain

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31100, France

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014, Italy

  • MD Anderson

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Monash Medical Centre

    Clayton, 3168, Australia

  • Novant Health

    Charlotte, North Carolina, 28204, United States

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103, United States

  • Oxford University Hospitals NHS Trust

    Oxfordshire, OX3 7LE, United Kingdom

  • Peter MacCallum Cancer Centre

    Melbourne, 3000, Australia

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G 1Z5, Canada

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • Universitatsklinikum Ulm

    Ulm, 89081, Germany

  • University College London Hospitals NHSFT

    London, NW1 2PG, United Kingdom

  • Westmead Hospital

    Westmead, 2145, Australia

More trials for these conditions

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