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Can an HDAC inhibitor wipe out residual leukemia cells?

NCT ID NCT07822789

Disease control Sponsor: Guangdong Second Provincial General Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are studying whether the drug chidamide can help keep high-risk acute myeloid leukemia (AML) in remission when used as maintenance therapy. The trial enrolls adults with specific genetic features and measurable residual disease who are not receiving a stem cell transplant. Participants receive chidamide for at least three months, and the study tracks whether the drug clears residual disease and how long patients stay in remission.

What this could mean

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

Active substance
chidamide, an HDAC inhibitor drug
What this could lead to
If chidamide helps, it could offer a maintenance option for high-risk AML patients who cannot receive a stem cell transplant, possibly keeping the disease in remission longer.
What could go wrong
This is a small, real-world study of 33 patients, so results may not apply broadly. Chidamide can cause side effects like fatigue, low blood counts, and digestive problems, and it may not clear residual disease in everyone.

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.

Participants

33 people

The number who actually took part.

Started

Jul 2026

Expected to finish

Jul 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.

Who is studied

High-risk patients who had completed standard induction and consolidation therapy and achieved complete remission (CR) or CR with incomplete peripheral blood count recovery (CRi), and could not receive allo-HSCT, and had taken chidamide as maintenance therapy for at least 3 months. High-risk patients were defined as those with CFB-AML and MRD positive, or patients with ELN 2022-high risk fusion genes, such as MLL rearrangement, or NUP98 rearrangement, ect.

Ages

18 to 80 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 range ≥18 years, both male and female were eligible. 2. Patients with CFB-AML and MRD positive, or patients with ELN 2022-high risk fusion genes, such as MLL rearrangement, or NUP98 rearrangement, ect. 3. Use of chidamide-based regimens as maintenance therapy for at least 3 months, without undergoing or not planning to undergo allo-HSCT. 4. ECOG ≤4; 5. At screening, laboratory tests meet the following criteria: (1) Complete blood count: hemoglobin (Hb) ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥90×10⁹/L; (2) Biochemical tests: serum creatinine (Cr) ≤1.5× upper limit of normal (ULN); total bilirubin (TBIL) ≤1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (for cases with liver metastasis: ≤5×ULN). Exclusion Criteria: 1. Known history of allergy to the study drug. 2. Resistant to chidamide. 3. Unable to take oral medications. 4. Concurrent uncontrolled active infection (including bacterial, fungal, or viral infections). 5. Concurrent uncontrolled major organ failure. 6. Currently participating in other clinical studies that affected the primary objectives of this study. 7. Patients deemed by the investigators to be 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.

Acute myeloid leukemia Maintenance therapy

Contacts and locations

Locations

  • Department of Hematology, Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong, China

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