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New combo aims to stop leukemia return after transplant

NCT ID NCT05270200

Disease control Sponsor: Zhujiang Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study is testing whether a combination of two drugs—azacitidine (given as a shot) and chidamide (taken as a pill)—can safely prevent high-risk acute myeloid leukemia from coming back after a stem cell transplant. About 20 adults aged 18 to 60 will receive six cycles of azacitidine plus up to two years of daily chidamide. Researchers will track side effects, relapse rates, and survival.

What this could mean

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

Active substance
azacitidine and chidamide
What this could lead to
If it works, this combination could help prevent leukemia from coming back after a stem cell transplant, giving patients more time without relapse.
What could go wrong
This is an early-phase study with only 20 participants, so results may not apply broadly. The drugs can cause side effects like low blood counts and infections.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

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

Started

Feb 2022

Expected to finish

Dec 2027

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 60 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: * 1.Age 18 to 60 years old,both male and female * 2.Be able to understand and sign informed consent * 3.Patients with a diagnosis of AML not M3 according to the 2016 World Health Organization (WHO) Acute Myeloid Leukemia Classification and Diagnostic * 4.Patients have AML with poor genetic abnormalities,primary refractory AML,relapsed AML or secondary AML * 5.Patients with an ECOG performance status 0,1,2 or 3 * 6.Expected survival time ≥ 3 months * 7.Non-hematological toxicity related to transplantation does not exceed Grade 2 * 8.Laboratory indicators meet the following standards: 1. 7 days before the first day of the first course of treatment, bilirubin, ALT and AST were all less than 3 times the upper limit of normal. 2. Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, the neutrophil count are greater than 1.5×10/L and without G-CSF treatment. 3. Measure twice within 7 days before the first day of the first course of treatment, at least 2 days apart, platelet count greater than 80×10/L and without platelet transfusion. 4. Serum creatinine clearance rate is greater than 30ml/min. Exclusion Criteria: * 1.Uncontrollable active infection * 2.Patients with active hepatitis B or C or HIV infection before enrollment * 3.Have a grade III-IV graft-versus-host disease

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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

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

  • Nanfang Hospital of Southern Medical University

    RECRUITING

    Guanzhou, Guandong, 510250, China

More trials for these conditions

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