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Can a new drug combo make stem cell transplants safer for frail AML patients?

NCT ID NCT07762508

Cure 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 13, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This trial is testing whether a new conditioning regimen, called VABu, can improve outcomes for adults with acute myeloid leukemia (AML) who are in first remission but are too frail for standard transplant prep. The regimen combines venetoclax, azacitidine (or decitabine), and busulfan, given before an allogeneic stem cell transplant. The study will follow 42 participants to see how many survive for two years after the transplant, and also track relapse, transplant-related complications, and infections. The goal is to find a safer, more effective way to prepare frail patients for a potentially curative transplant.

What this could mean

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

Active substance
A combination of venetoclax, azacitidine (or decitabine), and busulfan, given before a stem cell transplant.
What this could lead to
If successful, this could offer a safer and more effective transplant preparation for AML patients who are too frail for standard regimens, potentially improving their chances of long-term survival.
What could go wrong
This is a small, single-arm study, so results may not be conclusive. The regimen may still cause serious side effects, including infections or transplant-related complications, and may not improve outcomes for all patients.

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 42 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 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

18 to 70 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. Age 18 to 70 years. 2. Diagnosis of acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL), with first complete remission (CR1) achieved after induction chemotherapy. 3. Classified as non-high-risk per ELN 2022 risk stratification guidelines. 4. ECOG performance status ≥ 2 (not due to leukemia) OR Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) ≥ 2. 5. Willing to undergo allogeneic hematopoietic stem cell transplantation and has a suitable donor. 6. Voluntarily signs informed consent form after full understanding of the study. Exclusion Criteria: 1. Allergy to any component of the study drugs. 2. Psychiatric or psychological disorders that prevent cooperation with treatment. 3. Uncontrolled systemic or local severe infection. 4. Severe dysfunction of major organs (heart, lung, liver, kidney) that, in the investigator's opinion, makes the patient unsuitable for enrollment. 5. Currently participating in or planning to participate in any other clinical study. 6. Any other conditions that, in the investigator's opinion, make the patient unsuitable for enrollment.

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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.

Hematopoietic stem cell transplantation (HSCT) Leukemia, myeloid, acute(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

  • First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

More trials for these conditions

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