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Promising combo targets tough leukemia in vulnerable patients

NCT ID NCT07451912

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a combination of three drugs—venetoclax, a hypomethylating agent (azacitidine or decitabine), and low-dose cytarabine—can effectively treat adults newly diagnosed with a specific genetic subtype of acute myeloid leukemia (CEBPA-mutated AML) who are not healthy enough for intensive chemotherapy. The 29 participants will receive two cycles of induction therapy, and those who respond well will continue with at least four more cycles. Researchers will track how long patients stay cancer-free, their remission rates, and side effects.

What this could mean

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

Active substance
venetoclax, azacitidine or decitabine, and low-dose cytarabine
What this could lead to
If successful, this combination could offer a more effective and tolerable treatment option for people with this specific type of AML who cannot handle standard intensive chemotherapy.
What could go wrong
This is an early-phase trial with only 29 participants, so results may not apply broadly. The combination may cause significant side effects, and it is not yet known if it will improve long-term survival or prevent relapse.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 29 people

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

Started

Sep 2025

Expected to finish

Dec 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 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: * Patients can participate in this study only if they meet all the following enrollment criteria: 1. Aged over 18 years, male, or female who is neither pregnant nor lactating; 2. Newly diagnosed acute myeloid leukemia (AML) with CEBPA mutation; 3. ECOG performance status ≤ Grade 3; 4. Capable of understanding and willing to participate in the study, and able to sign the informed consent form; 5. Patients are judged as "unfit" according to the Ferrara criteria. A patient is considered "unfit" if they meet at least one of the following criteria: * Advanced age: \> 75 years old; * Presence of severe underlying comorbidities involving the heart, lungs, kidneys, or liver; ③ Presence of active infection unresponsive to anti-infective treatment; * Presence of cognitive impairment; ⑤ Poor performance status (persistent ECOG score ≥ Grade 3); ⑥ Other comorbidities judged by the investigator to make the patient unfit for intensive chemotherapy. Exclusion Criteria: * Patients are not suitable for participating in this study if they meet any of the following exclusion criteria: 1. Pregnant or lactating women; 2. Previous receipt of chemotherapy or targeted drug therapy for leukemia before the study treatment (except oral hydroxyurea used to reduce white blood cell count and/or leukapheresis); 3. As known to the participant and the investigator, the participant may be unable to complete all study visits or procedures required by the study protocol (including follow-up visits) and/or unable to comply with the required study procedures; 4. Other conditions judged by the investigator to make the patient unfit for participating in this study.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia with CEBPA somatic mutations

As listed by the trial registrant

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

Acute myeloid leukemia (AML) CEBPA mutation Unfit, new-diagnosis AML

How to take part

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

  1. The places running it

    1 site. 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

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

More trials for these conditions

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