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Experimental cocktail aims to beat back tough leukemia

NCT ID NCT05029141

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This phase 2 trial tests a combination of chidamide, azacytidine, and a chemotherapy regimen (HAG) in 21 adults with acute myeloid leukemia that has come back or not responded to treatment. The goal is to see how well the combo works and what side effects it causes. Participants receive two 28-day cycles of the drug regimen.

What this could mean

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

Active substance
chidamide, azacytidine, cytarabine, homoharringtonine, and granulocyte colony-stimulating factor
What this could lead to
If successful, this combination could offer a new treatment option for patients with hard-to-treat acute myeloid leukemia.
What could go wrong
This is a small, early-phase trial with only 21 participants, so results may not apply to everyone. The drugs can cause serious side effects like low blood counts and infection.

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

21 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Aug 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 69 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: * Adults aged ≥ 18 and ≤ 70 years * Patients diagnosed with AML according to 2016 WHO myeloid malignant disease diagnosis standard (Non-APL) * Patients with AML must meet one of the following criteria, A or B: A: Refractory AML disease was defined as follows: (1) failure to attain CR following exposure to at least 2 courses of standard or intensive induction therapy; or (2) bone marrow leukemia cell decline index (BMCDI) \< 50% and \> 20% after 1 course of standard or intensive induction therapy. B: Relapsed AML disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after CR; or (2) detection of ≥ 5% blasts in the BM not attributable to another cause (e.g., BM regeneration after consolidation therapy); or (3) extramedullary relapse. * ECOG performance status score less than 3 * Expected survival time ˃ 3 months * Patients without serious heart, lung, liver, or kidney disease * Ability to understand and voluntarily provide informed consent Exclusion Criteria: * Patients who are allergic to the study drug or drugs with similar chemical structures * Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception * Active infection * Active bleeding * Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment * Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met * Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, ALT/AST \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value) * Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment * Surgery on the main organs within the past six weeks * Drug abuse or long-term alcohol abuse that would affect the evaluation results * Patients who have received organ transplants (excepting bone marrow transplantation) * Patients not suitable for the study according to the investigator's assessment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • The First Affliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

More trials for these conditions

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