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Diabetes drug metformin takes on leukemia gene

NCT ID NCT07188740

Disease control Sponsor: Institute of Hematology & Blood Diseases Hospital, China 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This early-phase study tests whether metformin, a common diabetes drug, can lower the level of a harmful gene mutation (DNMT3A R882) in 30 people with acute leukemia who are in remission. Participants will take metformin pills for 6 months, and researchers will check if the mutation decreases. The goal is to see if this approach can help prevent the leukemia from coming back.

What this could mean

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

Active substance
Metformin
What this could lead to
If it works, this could point toward a way to lower the risk of leukemia relapse by targeting a specific gene mutation.
What could go wrong
This is a very early, small phase 1 trial with only 30 participants. It may not show a clear benefit, and metformin can cause side effects like stomach upset or low blood sugar.

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

About 32 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

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

14 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: * Patients diagnosed with acute leukemia based on bone marrow morphology, immunology, and genetics, per WHO 2022 or ICC criteria. * Patients in complete remission follow-up phase with DNMT3A R882 mutation clonal hematopoiesis, VAF ≥5%. * Age ≥14 years, any gender * Laboratory requirements (within 7 days before treatment): * Total bilirubin ≤1.5 × upper limit of normal (ULN) for age. * AST and ALT ≤2.5 × ULN for age. * Serum creatinine \<2 × ULN for age. * Cardiac enzymes \<2 × ULN for age. * Ejection fraction within normal range by echocardiogram (ECHO). * Signed informed consent: By patient (≥18 years) or legal guardian/relative (\<18 years or if beneficial for condition). Exclusion Criteria: * Patients with diabetes receiving other medications * Known allergy to metformin * Deemed unsuitable by investigator

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Conditions

The condition(s) this trial relates to.

acute leukemia

As listed by the trial registrant

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

DNMT3A gene mutation

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

  • Blood Diseases Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

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