Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New maintenance treatment aims to keep favorable risk AML in remission

NCT ID NCT06379360

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Updated 1 time

Summary

This study tests whether a maintenance therapy using a hypomethylating agent (HMA) can help prevent relapse and improve survival in people with favorable risk acute myeloid leukemia (AML). About 77 participants who are already in remission after initial treatment will receive HMA maintenance. The goal is to see if this approach extends the time without leukemia returning.

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 60 people

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

Started

Jul 2019

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

16 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: 1. Patients aged ≥16 years; 2. Patients diagnosed with AML and categorized into favorable-risk group according to European LeukemiaNet (ELN) 2017; 3. Patients achieved remission after induction therapy and completed at least 3 cycles of high-dose cytarabine-based consolidation therapy, remaining in FCM-MRD-negative remission at enrollment. FCM-MRD was assessed by multiparameter flow cytometry, in accordance with expert consensus from China, with MRD positivity defined as ≥0.1%. 4. Patients not receiving hematopoietic stem cell transplantation prior to enrollment; 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 6. Expected survival time ≥ 3 months; 7. No serious heart, lung, liver or kidney disease; 8. Have the ability to understand and be willing to sign the informed consent form for this trial. Exclusion Criteria: 1. Patients experienced hematologic relapse before recruitment. 2. Patients who are allergic to the study drug or drugs with similar chemical structures. 3. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception. 4. Active infection. 5. Active bleeding. 6. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment. 7. 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. 8. Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, Alanine Aminotransferase (ALT) / Aspartate Aminotransferase (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). 9. Patients with a history of clinically significant Corrected QT Interval (QTc) 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. 10. Surgery on the main organs within the past six weeks. 11. Drug abuse or long-term alcohol abuse that would affect the evaluation results. Patients who have received organ transplants (excepting bone marrow transplantation). 12. Patients not suitable for the study according to the investigator's assessment.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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 Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

More trials for these conditions

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