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New pill aims to keep leukemia away after transplant

NCT ID NCT07304232

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This phase II trial tests whether the drug chidamide can help prevent acute myeloid leukemia (AML) from coming back after a stem cell transplant. About 134 adults with high-risk AML who are in remission after transplant will either take chidamide pills or receive standard observation. The study tracks how long patients stay cancer-free and any side effects.

What this could mean

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

Active substance
Chidamide (a type of drug called a histone deacetylase inhibitor, taken as a pill)
What this could lead to
If successful, this could offer a new maintenance option to help prevent AML relapse after a stem cell transplant, potentially improving long-term survival.
What could go wrong
This is a mid-stage trial with only 134 participants, so results may not apply to all patients. Chidamide may cause side effects like fatigue or low blood counts, and it is not yet proven to extend survival.

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 134 people

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

Started

Sep 2025

Expected to finish

Dec 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 75 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. AML patients meeting the following conditions (diagnosed per WHO 2022 AML criteria) who achieved first complete remission (CR) with intermediate-/high-risk cytogenetic abnormalities at the time of allogeneic transplantation. 2. Patients must achieve complete remission (CR) post-transplantation. 3. Enrollment must occur between 60 and 100 days after transplantation. 4. Age 18 to 75 years. 5. ECOG performance status 0-1. 6. Serum creatinine \< 1.5 × ULN (upper limit of normal). 7. Serum direct bilirubin \< 1.5 mg/dL (except in Gilbert's syndrome). 8. ALT and AST \< 2.5 × ULN. 9. Ability to understand and provide written informed consent. Exclusion Criteria: 1. Receipt of any other investigational drugs post-transplantation. 2. FLT3 mutation-positive status. 3. Central nervous system (CNS) involvement. 4. Uncontrolled grade 2-4 graft-versus-host disease (GVHD). 5. Uncontrolled active infection. 6. Known or suspected hypersensitivity to Chidamide or its excipients. 7. Uncontrolled congestive heart failure (CHF) or other concomitant systemic diseases or severe complications that, in the investigator's judgment, would make the patient unsuitable for participation in this study or would significantly compromise the proper assessment of the safety and toxicity of the prescribed regimen. 8. Pregnancy or breastfeeding. 9. Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study.

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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.

Allogeneic hematopoietic cell transplantation (HCT) AML - acute myeloid leukemia

How to take part

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

  1. The places running it

    5 sites. 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

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • The First Affiliated Hospital of Harbin Medical University

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, 150001, China

  • The Second Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • Tianjin Medical University General Hospital

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Tianjin People's Hospital

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

More trials for these conditions

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