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 type | Interventional |
|---|---|
| Ages | 55 Years and up |
| Sex | All |
| Enrollment | 307 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | October 31, 2027 |
| Study ends | October 31, 2027 |
| Registry record updated | September 14, 2026 |
| Trial ID | NCT06946602 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
- Study coordinator: Yuqian Sun
- Email: sunyuqian83@hotmail.com
- Phone: 861088326666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.