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New triple therapy offers hope for AML patients

NCT ID NCT07490288

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study tests a new combination of three drugs (venetoclax, azacitidine, and liposomal mitoxantrone) as the first treatment for adults with newly diagnosed acute myeloid leukemia (AML). About 30 participants will receive this therapy, followed by standard chemotherapy and, for high-risk patients, a stem cell transplant. The goal is to see if this approach is safe and improves remission rates.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 27 people

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

Started

May 2026

Expected to finish

Mar 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 to 100 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: * Patients diagnosed with AML according to the WHO (2022) or ICC criteria, or with MDS/AML as defined by ICC (with 10%-20% blasts in the bone marrow) * Age ≥ 14 years, male or female. * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2. * Meet the following laboratory requirements (tests must be performed within 7 days prior to treatment): i. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the corresponding age group. ii. AST and ALT ≤ 2.5 times ULN for the corresponding age group. iii. Serum creatinine \< 1.5 times ULN for the corresponding age group. iv. Cardiac enzymes \< 2 times ULN for the corresponding age group. v. Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiography (ECHO). Exclusion Criteria: * Acute promyelocytic leukemia with PML::RARA fusion gene. * Acute myeloid leukemia with RUNX1::RUNX1T1 fusion gene. * Acute myeloid leukemia with BCR::ABL1 fusion gene. * Previously treated patients (defined as having received prior induction chemotherapy for AML/MDS; prior use of cytoreductive agents like hydroxyurea is allowed). * Concurrent active malignancy of other organs (requiring treatment). * Active cardiac disease, defined as one or more of the following: i. History of uncontrolled or symptomatic angina. ii. Myocardial infarction within 6 months prior to study enrollment. iii. History of clinically significant arrhythmia requiring medication or causing severe symptoms. iv. Uncontrolled or symptomatic congestive heart failure (\> New York Heart Association \[NYHA\] Class 2). * Active, uncontrolled infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis). * Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.

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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 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

  • Blood diseases hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

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