Can a Four-Drug prep make curative transplant safer for older AML patients?
NCT ID NCT06946602
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Older adults with acute myeloid leukemia (AML) often fare poorly with chemotherapy alone, and a stem cell transplant can offer better long-term survival but carries a high risk of transplant-related death. Researchers are comparing two drug combinations given before a haploidentical transplant, one that adds fludarabine to busulfan, cyclophosphamide, and anti-thymocyte globulin, and one without fludarabine. The trial enrolls patients aged 55 and older in first complete remission who have a half-matched donor. The goal is to see whether the fludarabine-containing regimen lowers transplant-related mortality.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Two conditioning regimens given before haploidentical stem cell transplant: one adds fludarabine to busulfan, cyclophosphamide, and anti-thymocyte globulin
- What this could lead to
- If the fludarabine-containing regimen works, it could give older AML patients a safer path to a potentially curative stem cell transplant.
- What could go wrong
- The trial may show no difference in transplant-related mortality, or the added drug could raise toxicity. Older patients face higher risks from transplant regardless of regimen.
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 307 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2026
- Expected to finish
-
Oct 2027
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 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 Hide 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: \- (a)Diagnosed with AML in first complete remission (CR1). (b)Age ≥55 years. (c)Availability of an haploidentical donor, first transplant, no matched sibling or unrelated donor. (d)Willingness to provide written informed consent. Exclusion Criteria: * (a) Uncontrolled active infection. (b) Secondary AML. (c)Refusal to provide informed consent.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for AML are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Peking University People's Hospital
RECRUITINGBeijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Breath test aims to classify leukaemia in hours, not days
- Can a detailed health check predict who thrives after a stem cell transplant?
- Gentler transplant prep aims to cure tough blood cancers
- Can a Chemo-Transplant combo rescue patients whose leukemia resists standard treatment?
- Can a liposomal chemo combo improve outcomes before stem cell transplant?
- Could a toothbrush and mouthwash cut pneumonia in the elderly?