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Can a liposomal drug combo improve AML treatment for older adults?

NCT ID NCT07828535

Disease control Sponsor: Institute of Hematology & Blood Diseases Hospital, China Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are testing a three-drug regimen called VAM for older or unfit adults with newly diagnosed acute myeloid leukemia (AML). The regimen combines liposomal mitoxantrone, azacitidine, and venetoclax. The trial aims to find the safest and most tolerable dose of liposomal mitoxantrone and to see how well the combination controls the disease. About 30 participants will receive up to two induction cycles, followed by consolidation and maintenance for those who respond.

What this could mean

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

Active substance
liposomal mitoxantrone given with azacitidine and venetoclax
What this could lead to
If it works, this could offer a new treatment option for older or frail adults with newly diagnosed AML who cannot handle standard intensive chemotherapy.
What could go wrong
This is an early phase 1b trial with about 30 patients, so researchers mainly test safety and dosing. The combination may cause serious side effects or fail to control leukemia, and any benefit would need confirmation in larger trials.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

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 99 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: * Subjects eligible for enrollment in this study must meet all of the following criteria: 1. Diagnosis of acute myeloid leukemia (AML) according to the WHO 2022 or ICC criteria, excluding acute promyelocytic leukemia (APL). 2. No prior therapy for AML, except hydroxyurea for the management of hyperleukocytosis. 3. Meeting at least one of the following criteria: 1. Age ≥ 75 years; 2. Age 18-74 years with at least one of the following conditions precluding suitability for intensive chemotherapy: i. ECOG performance status 2-3; ii. Cardiac dysfunction with left ventricular ejection fraction (LVEF) ≤ 50%; iii. Pulmonary dysfunction with diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%; iv. Creatinine clearance 30-45 mL/min; v. Other major organ dysfunction or comorbidities that, in the investigator's judgment, render the patient unsuitable for intensive chemotherapy. 4. ECOG performance status 0-3. 5. Life expectancy ≥ 3 months. 6. Patients of childbearing potential agree to use effective contraception during the treatment period and for at least 6 months after the last dose of study treatment. 7. Voluntary written informed consent provided. Exclusion Criteria: * Subjects who meet any of the following criteria will not be eligible for enrollment in this study: 1. Acute promyelocytic leukemia (APL).. 2. Active central nervous system (CNS) leukemia. 3. Prior targeted therapy or chemotherapy for AML, excluding hydroxyurea. 4. Uncontrolled active infection. 5. Uncontrolled cardiovascular disease: New York Heart Association (NYHA) class III-IV heart failure, myocardial infarction or unstable angina within 6 months before enrollment, or uncontrolled hypertension. 6. Left ventricular ejection fraction (LVEF) \< 40%. 7. Concurrent active malignancy, except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer. 8. Known hypersensitivity to the study drugs or their excipients. 9. Pregnant or breastfeeding women. 10. Any other condition that, in the investigator's judgment, would make the patient unsuitable for study participation.

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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 (AML)

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

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