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New combo aims to stop leukemia return in High-Risk patients

NCT ID NCT05361057

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 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 study tested whether combining venetoclax with either azacytidine or a DA chemotherapy regimen could prevent relapse in acute myeloid leukemia patients who still have detectable cancer cells (MRD positive) after standard treatment. The trial planned to enroll 20 adults in complete remission but with high-risk MRD. Unfortunately, the study was terminated early, so full results are not available.

What this could mean

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

Active substance
Venetoclax combined with azacytidine or daunorubicin and cytarabine
What this could lead to
If successful, this approach could help prevent leukemia relapse in patients with persistent minimal residual disease who cannot undergo stem cell transplant.
What could go wrong
The trial was terminated early with only 20 participants, so results are limited. The combination drugs have significant side effects like low blood counts and infection risk.

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

20 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 2024

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 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. Diagnosed acute myeloid leukemia 2. Received chemotherapy within 24 months and has completed the consolidation treatment plan 3. In complete remission 4. With MRD positive: abnormal myeloid cells in bone marrow ≥ 0.1%, or NPM1 gene mutation and other fusion gene positive(RUNX 1-RUNX1T 1、CBFB-MYH11 and DEK-NUP214), the PCR quantification ≥1%. 5. Age≥ 18 years #male or female 6. ECOG-PS score 0-2 7. Aboratory tests#within 7 days before chemotherapy# 1). Serum total bilirubin≤1.5xULN# 2). Serum AST and ALT≤2.5xULN 3). Serum creatinine≤2xULN# 4). Cardiac enzymes≤2xULN 5). Ejection fraction \>50% by ECHO# 8. Written informed consent Exclusion Criteria: 1. Hematological relapse (the proportion of blast cells in bone marrow is greater than 5%) 2. Receive hematopoietic stem cell transplantation within 4 weeks 3. APL 4. Have been treated with venetoclax in the past 6 months (who can be enrolled after stopping for more than 6 months) 5. Suffering from malignant tumors of other organs (those requiring treatment) 6. Pregnant or lactating women 7. Active heart diseases 8. Severe active infection 9. Unfit for enrollment evaluated by investigator

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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 Measurable disease

Contacts and locations

Locations

  • HBDH

    Tianjin, Tianjin Municipality, 300020, China

More trials for these conditions

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