Clinical trial Recruiting at 1 site Interventional Ages 55 and up

Conditioning regimens for elderly AML patients receiving haplo-HSCT

Official title: Bu/Cy/Flu/ATG Versus Bu/Cy/ATG Conditioning Regimen in Elderly AML Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation: a Prospective, Randomized, Controlled Study

Run by Peking University People's Hospital · NCT06946602 · Data updated 2026-11-12

This trial tests whether a fludarabine-based conditioning plan (Bu/Flu/Cy/ATG) reduces transplant-related mortality compared with a cyclophosphamide-based plan (Bu/Cy/ATG) in elderly AML patients getting haploidentical stem cell transplants.

Quick facts

Study typeInterventional
Ages55 Years and up
SexAll
Enrollment307 (estimated)
SponsorPeking University People's Hospital
Academic / other
Drugs / interventionschemotherapy, cyclophosphamide, fludarabine
Locations1 site (Beijing)
StatusRecruiting
StartedJanuary 1, 2026
Main results expectedOctober 31, 2027
Study endsOctober 31, 2027
Registry record updatedSeptember 14, 2026
Trial IDNCT06946602 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are AML patients aged 55 or older in CR1 with a haploidentical donor and no matched sibling/unrelated donor.

Probably not a fit

Patients with uncontrolled infections, secondary AML, or who refuse consent may not benefit and are excluded.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In elderly patients with AML, transplantation can improve long-term survival but carries high treatment-related risk. This randomized trial compares two conditioning regimens before haplo-HSCT to see if reducing toxicity lowers mortality. The study builds on prior single-arm data suggesting Bu/Flu/Cy/ATG may be safer and seeks prospective evidence. Eligible participants are adults 55 and older in first complete remission with a haploidentical donor. Outcomes include transplant-related mortality and safety profiles between regimens.

Why it matters

Potential benefit: If Bu/Flu/Cy/ATG proves safer, more elderly AML patients could become eligible for haplo-HSCT with lower early mortality.

How similar studies have gone: Previous single-arm data suggested Bu/Flu/Cy/ATG is safe and effective, but randomized evidence was lacking.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Peking University People's Hospital
    Beijing, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.