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New Three-Drug cocktail aims to beat aggressive leukemia

NCT ID NCT07605949

Disease control Sponsor: UNC Lineberger Comprehensive Cancer Center 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 7 times

Summary

This study tests a new combination of three drugs—revumenib, azacitidine, and venetoclax—in people newly diagnosed with a specific, hard-to-treat leukemia called KMT2A-rearranged AML. The goal is to see if this cocktail can help more patients achieve remission with fewer side effects. The trial will enroll 88 adults and includes a phase where some patients may continue treatment after a stem cell transplant.

What this could mean

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

Active substance
revumenib, azacitidine, and venetoclax
What this could lead to
If successful, this combination could offer a more effective and less toxic first treatment for people with this aggressive leukemia, potentially leading to better remission rates and survival.
What could go wrong
This is a Phase 2 trial with only 88 participants, so results are preliminary. The drug combination may cause significant side effects, and not all patients may respond. It is not yet proven to be better than standard care.

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 88 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 65 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: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee. * Age 18-65 years at the time of consent. * Untreated AML based on 2022 WHO or ICC criteria with KMT2A translocation by local standard diagnostic testing by cytogenetics/karyotype or FISH Exclusion Criteria: * Isolated myeloid sarcoma (patients must have blood or marrow involvement with AML to enter study) * Active central nervous system (CNS) involvement by AML. Of note, patients are eligible if CNS leukemia is in remission at the time of study entry. * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia, MLL gene rearrangement

As listed by the trial registrant

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

Leukemia acute myeloid

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295, United States

More trials for these conditions

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