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Triple-Drug cocktail aims to boost remission in acute myeloid leukemia

NCT ID NCT05654194

Disease control Sponsor: The First Affiliated Hospital of Soochow University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 3 trial is testing whether a combination of three drugs—azacitidine, venetoclax, and ATRA—can safely and effectively treat adults newly diagnosed with acute myeloid leukemia (AML). The drugs work together to stop cancer cell growth by demethylating DNA, promoting cell differentiation, and killing cancer cells. Participants receive the combination in cycles as induction, consolidation, and maintenance therapy. The main goal is to see how many patients achieve complete remission after the first cycle.

What this could mean

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

Active substance
azacitidine, venetoclax, and ATRA (all-trans retinoic acid)
What this could lead to
If successful, this three-drug combination could offer a more effective initial treatment for acute myeloid leukemia, potentially leading to higher remission rates without the need for intensive chemotherapy.
What could go wrong
This is a single-arm, early-phase trial with a small number of participants, so results may not apply to all AML patients. The combination may cause significant side effects, and it is not yet known if it improves long-term 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

60 people

The number who actually took part.

Started

Oct 2022

Finished

Feb 2026

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: * Newly diagnosed AML according to the WHO (2016) classification of acute myeloid leukemia. * Age ≥ 18years. * ECOG score: 0-3. * White blood cell count ≤ 25\*10\^9/L * Total bilirubin ≤ 3X the institutional upper limit of normal if attributable to hepatic infiltration by neoplastic disease * AST (SGOT) and ALT (SGPT) ≤ 3X the institutional upper limit of normal * Creatinine clearance ≥30ml/min Exclusion Criteria: * Pregnancy or lactation. * Acute promylocytic leukemia or chronic myeloid leukemia in blast crisis. * Another malignant disease. * Uncontrolled active infection. * Left ventricular ejection fraction \< 0.3 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification. * Active hepatitis B or hepatitis C infection. * HIV infection. * Other commodities that the investigators considered not suitable for the enrollment.

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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

Contacts and locations

Locations

  • the First Affiliated Hospital of Soochow University

    Suzhou, China

More trials for these conditions

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