Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 65

Age-stratified conditioning regimens to improve outcomes in haploidentical stem cell transplant for myelodysplastic syndrome

Official title: Prospective Cohort Study of Age-Stratified Busulfan-Based Conditioning Regimens in Adult Patients With Myelodysplastic Syndrome Receiving Haploidentical Hematopoietic Stem Cell Transplantation

Run by Peking University People's Hospital · NCT07677306 · Data updated 2026-11-12

This study tests two conditioning regimens in adults with MDS undergoing haploidentical stem cell transplant to see how age affects outcomes over one year.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment120 (estimated)
SponsorPeking University People's Hospital
Academic / other
Locations1 site (Beijing)
StatusRecruiting
StartedJuly 15, 2026
Main results expectedDecember 31, 2027
Study endsJune 30, 2028
Registry record updatedSeptember 16, 2026
Trial IDNCT07677306 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with low- or intermediate-risk MDS without ISD or URD who are planned for haploidentical stem cell transplantation.

Probably not a fit

Patients with high-risk MDS, active infection, organ failure, or poor ability to comply may not benefit and could be at higher risk from conditioning toxicity.

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

What this trial studies

This Phase 2 interventional trial enrolls adults with myelodysplastic syndrome who are planned for T-cell-replete haploidentical hematopoietic stem cell transplantation. Participants aged 55 and older receive a reduced-toxicity Bu/Flu/Cy/ATG conditioning, while those younger than 55 receive a standard myeloablative Bu/Cy+ATG regimen, followed by uniform post-transplant care. The study prospectively characterizes 1-year transplant-related mortality and evaluates engraftment, graft-versus-host disease, infection, relapse, survival, and conditioning-related organ toxicity. Primary aim is to understand how age-stratified conditioning influences transplant-related outcomes across all enrolled patients. Safety and feasibility data will inform future optimization of conditioning for haploidentical transplants in MDS.

Why it matters

Potential benefit: If successful, the approach could improve survival and reduce transplant-related toxicity for adults with MDS undergoing haploidentical transplantation.

How similar studies have gone: Prior studies in haploidentical transplantation support the feasibility and safety of varied conditioning regimens, but age-stratified approaches for outcome optimization are less established and exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients who had low- and intermediate-risk MDS without ISD nor URD receiving haploidentical hematopoietic stem cell transplantation

Exclusion Criteria:

* Patients having ISD or URD; patients having high-risk MDS; patients with active infection; patients with poor compliance; patients with organ failure

Where it's running

  • Peking University People's Hospital, Beijing Lu Daopei Hematology Hospital, Hebei Yanda Lu Daopei Hospital, Nanfang Hospital, Southern Medical University
    Beijing, China
    Recruiting

Study contacts

  • Principal investigator: Xiao-Jun Huang — Peking University Institute of Hematology
  • Study coordinator: Yu Wang
  • Email: ywyw3172@sina.com
  • Phone: 8610-8832-6005

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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.