Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New pill aims to keep leukemia away after transplant

NCT ID NCT07563010

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a new oral drug called revumenib in people with acute myeloid leukemia (AML) who have certain genetic changes. After a stem cell transplant, participants will take revumenib or a placebo to see if it helps keep the cancer from coming back. The trial involves 144 adults and focuses on improving long-term survival without relapse.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 146 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

18 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: Inclusion Criteria: 1. Aged ≥18 years at the time of signing informed consent 2. Able to provide written informed consent personally or via a legally authorized representative in accordance with applicable regulatory and institutional requirements 3. Willing and able to comply with all study procedures and available for the duration of the study 4. Diagnosis of acute myeloid leukemia (AML) in complete morphologic remission with one of the following molecular abnormalities: 1\. KMT2A-rearranged (KMT2Ar) AML (Excluding KMT2A partial tandem duplication (KMT2A-PTD) 2. NPM1-mutated (NPM1m) AML (Including FLT3-ITD or TKD co-mutation) 3. NUP98-rearranged (NUP98r) AML 5. Planned first allogeneic hematopoietic cell transplantation (allo-HCT) for AML. 6\. Transplant Characteristics 1. Planned allo-HCT using bone marrow or peripheral blood stem cell graft source. 2. Planned reduced-intensity/non-myeloablative conditioning (RIC/NMA) or myeloablative conditioning (MAC), using a conditioning regimen permitted- by the protocol and consistent with standard clinical practice, meeting CIBMTR criteria for conditioning intensity 7\. Planned donor: 1. HLA-matched related donor (5/6 or 6/6) 2. Matched unrelated donor (8/8) 3. Mismatched unrelated donor (7/8) 4. Haploidentical donor meeting institutional requirements 8\. Performance Status: 1\. Karnofsky Performance Status ≥70%. 9. Cardiac Function: left ventricular ejection fraction (LVEF) by transthoracic echocardiogram (TTE) or multigated acquisition (MUGA) with no clinical evidence of heart failure: RIC/NMA: ≥50% MAC: ≥5 10. Pulmonary function meeting the following criteria, without supplemental oxygen other than CPAP: 1. RIC/NMA: DLCO (corrected for hemoglobin) and FEV1 ≥40% predicted 2. MAC: DLCO and FEV1 ≥50% predicted 11\. Renal Function: estimated creatinine clearance (CrCl) ≥45mL/min calculated using the Cockcroft-Gault formula or 24-hour urine collection, consistent with standard eligibility criteria for allogeneic HCT recipients. 12\. Liver function acceptable per local institutional guidelines for allo-HCT eligibility. 13\. Reproductive Status: Willingness to use contraception in accordance with local regulations from first study intervention through the required contraceptive period Willingness to use contraception in accordance with local regulations from first study intervention through the required contraceptive period Exclusion Criteria: 1. Disease Status: a. Evidence of active AML prior to HCT, assessed within 42 days before transplant, defined as any of the following: * ≥5% bone marrow blasts * Circulating blasts within 14 days before conditioning * CNS or other extramedullary disease 2. Other active malignancy that, in the investigator's judgment, could interfere with safety or efficacy assessment 3. Treatment with non-protocol antileukemic therapy (donor lymphocyte infusion for relapse prophylaxis or treatment will be considered an EFS event) 4. Cardiac / QT Risk 1. Requirement for concomitant medications known to prolong QT/QTc interval, except low-risk agents used as standard supportive care 2. Diagnosis or suspicion of Long QT syndrome, or a family history of Long QT syndrome 3. Fridericia's corrected QT interval (QTcF) \>450 msec. 4. History within 6 months of study entry of: i. Myocardial infarction ii. Unstable angina iii. Congestive heart failure (NYHA Class ≥ II) iv. Life-threatening or uncontrolled arrhythmia v. Cerebrovascular accident or transient ischemic attack 5. Chronic respiratory disease requiring continuous supplemental oxygen, or other significant organ dysfunction that would adversely affect study participation. 6. Active, uncontrolled infection, including any of the following: 1. Active, uncontrolled systemic fungal, bacterial, or viral infection within 14 days prior to the start of conditioning 2. Any other documented active, uncontrolled infection at the start of conditioning 7. Chronic viral infections with evidence of active disease, including: HIV: detectable viral load within 6 months prior to screening Hepatitis B: * HBsAg-positive and/or anti-HBc-positive with detectable HBV DNA * Anti-HBc-positive alone Hepatitis C: positive HCV antibody with detectable HCV RNA 8. Planned HCT using cord blood, ex vivo T cell depletion, engineered grafts, or experimental graft sources 9. Malabsorption syndrome or GI condition that precludes oral administration, including: 1. Inability to swallow oral medications 2. Prior gastric bypass or severe gastroparesis 3. Cirrhosis with Child-Pugh Class B or C 10. Pregnant or breastfeeding 11. Prior intolerance to menin inhibitor therapy resulting in ≥ Grade 3 treatment-related adverse events 12. Any condition, therapy, laboratory abnormality, or allergy to excipients that, in the investigator's judgment, could confound study results, interfere with the participant's ability to comply with study procedures or complete the study, or make participation not in the participant's best interest.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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