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New drug cocktail aims to boost transplant success in elderly leukemia patients

NCT ID NCT07563920

Disease control Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a combination of three chemotherapy drugs (thiotepa, busulfan, and fludarabine) given before a stem cell transplant can help older adults with acute myeloid leukemia stay in remission longer. About 93 patients aged 55 to 75 who are in their first remission will receive the treatment and be followed for at least a year. The goal is to see if this approach reduces relapse and improves survival, while managing side effects like graft-versus-host disease.

What this could mean

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

Active substance
thiotepa, busulfan, and fludarabine (TBF) chemotherapy
What this could lead to
If successful, this approach could offer elderly AML patients a better chance at long-term disease control after a stem cell transplant from a partially matched donor.
What could go wrong
This is a small, early-stage study at one center, so results may not apply broadly. The chemotherapy and transplant carry serious risks like infection, graft-versus-host disease, and organ damage.

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 93 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

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

55 to 75 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: * Age 55 to 75 years * Diagnosed with acute myeloid leukemia (AML) based on morphology, immunophenotyping, cytogenetics, or molecular testing * First complete remission (CR1) or complete remission with incomplete hematologic recovery (CRi) * Eligible for haploidentical hematopoietic stem cell transplantation * Availability of a suitable haploidentical donor * ECOG performance status 0-2 * Adequate organ function: * Left ventricular ejection fraction ≥50% * Oxygen saturation \>92% on room air * Serum creatinine ≤1.5 × upper limit of normal (ULN) * Total bilirubin ≤1.5 × ULN * AST and ALT ≤2.0 × ULN * DLCO ≥40% and FEV1 ≥50% * Ability to understand and sign informed consent Exclusion Criteria: * Secondary AML (including AML evolving from myelodysplastic syndrome or therapy-related AML) * Active, uncontrolled infection * Severe uncontrolled systemic disease (e.g., unstable cardiovascular disease, recent stroke, or severe organ dysfunction) * HIV infection * Active hepatitis B or C requiring antiviral treatment * Pregnant or breastfeeding women * Known hypersensitivity to study drugs

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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

How to take part

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  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

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More trials for these conditions

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