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Can a new drug combo outperform standard care for a tough blood cancer?

NCT ID NCT07754799

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This trial is testing whether adding the drug venetoclax to different chemotherapy regimens can improve outcomes for people newly diagnosed with acute myeloid leukemia (AML). It compares three experimental combinations against the standard treatment in 320 patients aged 14 and older. The goal is to find the most promising regimen to take forward into a larger study.

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 chemotherapy drugs (daunorubicin, cytarabine, liposome mitoxantrone, azacitidine)
What this could lead to
If successful, this trial could identify a more effective initial treatment for acute myeloid leukemia, potentially improving remission rates and survival.
What could go wrong
This is a phase II trial, so results are preliminary. The experimental combinations may not prove better than standard care and could carry additional side effects.

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 320 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

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

14 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: * Diagnosis of AML per WHO (2022) or ICC criteria, and MDS/AML as defined by ICC (with bone marrow blast percentage of 10%-20%). * Age ≥14 years, male or female. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Judged by the investigator to be suitable for intensive induction chemotherapy and expected to tolerate the treatment intensity specified in the protocol. * Meet the following laboratory test requirements (assessed within 7 days prior to treatment): 1. Total bilirubin ≤1.5 × upper limit of normal (ULN) for the same age group; 2. AST and ALT ≤2.5 × ULN for the same age group; 3. Serum creatinine \<2 × ULN for the same age group; 4. Cardiac enzymes \<2 × ULN for the same age group; 5. Cardiac ejection fraction determined by echocardiography (ECHO) within the normal range. * Written informed consent must be signed before any study specific procedures are initiated, by the patient themselves or by their immediate family members. If, in consideration of the patient's medical condition, signing by the patient themselves would be detrimental to their treatment, the informed consent may be signed by the legally authorized representative or the patient's immediate family members. Exclusion Criteria: * Acute promyelocytic leukemia with PML-RARA fusion gene. * Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene. * Acute myeloid leukemia with BCR-ABL fusion gene. * Presence of FLT3 mutation (these patients are recommended to be enrolled in clinical trials of FLT3 inhibitors). * Patients who have previously received induction chemotherapy (however, cytoreductive therapy such as hydroxyurea is permitted). * Concurrent malignancy of other organs that requires treatment. * Active cardiac disease, defined as one or more of the following: 1. History of uncontrolled or symptomatic angina pectoris; 2. Myocardial infarction within 6 months prior to study enrollment; 3. History of arrhythmia requiring medication or with clinically significant symptoms; 4. Uncontrolled or symptomatic congestive heart failure (\> NYHA class 2). * Serious infectious diseases (e.g., active tuberculosis, pulmonary aspergillosis). * Patients deemed unsuitable for enrollment by the investigator.

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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.

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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