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Can a new drug pair beat standard chemotherapy for tough AML?

NCT ID NCT05939180

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether the combination of venetoclax and azacytidine works better than the standard chemotherapy regimen of daunorubicin plus cytarabine in adults aged 18 to 64 with newly diagnosed acute myeloid leukemia that has adverse risk features. Participants are randomly assigned to one of the two treatments. After remission, they may receive consolidation chemotherapy and are strongly encouraged to undergo a stem cell transplant. Researchers track remission rates, how long remission lasts, and overall survival over up to two years.

What this could mean

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

Active substance
venetoclax plus azacytidine
What this could lead to
If it works, this combination could offer a more effective first treatment for adults with high-risk AML, potentially improving remission rates and survival.
What could go wrong
This is a mid-stage trial with 116 participants, so results may not hold in larger groups. The drugs can cause serious side effects, including infections and low blood counts.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 116 people

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

Started

Apr 2024

Expected to finish

May 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

18 to 64 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. Gender: female or male. 2. Age:18-64 years old. 3. Patients with newly diagnosed AML according to the WHO 2022 classification. 4. AML patients with adverse risk features according to the 2022 European Leukemia Net risk stratification. 5. Untreated AML (hydroxyurea, and low dose cytarabine with cummulative dose \<1.0g are permitted). 6. ECOG: 0-2. 7. Adequate liver function: Total bilirubin ≤ 1.5×upper limit of normal (ULN); aspartate aminotransferase (AST) ≤3×ULN (liver infiltration of leukemia: ≤5×ULN); alanine aminotransferase (ALT)≤3×ULN (liver infiltration of leukemia: ≤5×ULN) . 8. Adequate Renal function: Ccr (Creatinine Clearance Rate) ≥30 ml/min. 9. Be able to understand and be willing to participate in the study. Be able to provide written informed consent. Exclusion Criteria: 1. Patients with acute promyeloid leukemia. 2. AML with central nervous system infiltration. 3. Patients diagnosed with myeloid sarcoma. 4. Patients have AML secondary to MDS and previously been treated with hypomethylating agents. 5. Patients with active infection, which is considered as uncontrollable by the investigator. 6. Patients with active hepatitis B, hepatitis C and HIV infection. 7. Patients with heart failure (grade 3-4); 8. Patients who are pregnant or breastfeeding. 9. Patients who refused to be enrolled in the study. Patients who are considered as ineligible for the enrollment by the investigators.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ethical Committee of the First Affliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

    RECRUITING

    Suzhou, Jiangsu, 215000, China

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