Clinical trial Recruiting at 1 site Observational Ages 55 to 70

Evaluating Haplo-HSCT for Elderly Patients with Acute Leukemia or Myelodysplastic Syndrome

Official title: Clinical Registration Study of Haploidentical Stem Cell Transplantation for Elderly Patients With Acute Leukemia or Myelodysplastic Syndrome

Run by Peking University People's Hospital · NCT05902416 · Data updated 2026-11-12

This study is testing a gentler stem cell transplant method for older patients with acute leukemia or myelodysplastic syndromes who don't have a matched donor, to see if it helps them live longer and stay healthier after the procedure.

More Myelodysplastic Syndromes trials

Quick facts

Study typeObservational
Ages55 Years to 70 Years
SexAll
Enrollment120 (estimated)
SponsorPeking University People's Hospital
Academic / other
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJune 1, 2023
Main results expectedJune 2025
Study endsDecember 2026
Registry record updatedSeptember 19, 2024
Trial IDNCT05902416 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are elderly patients aged 55 to 70 with acute leukemia or myelodysplastic syndromes who lack HLA-matched donors.

Probably not a fit

Patients with severe infections or those not eligible for hematopoietic stem cell transplantation will not benefit from this study.

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

What this trial studies

This observational study aims to assess the efficacy of a reduced-intensity conditioning (RIC) regimen for haploidentical hematopoietic stem cell transplantation (Haplo-HSCT) in elderly patients aged 55 to 70 with acute leukemia or myelodysplastic syndromes. The study focuses on patients who do not have HLA-matched donors but have access to haploidentical donors. Primary endpoints include one-year leukemia-free survival, while secondary endpoints will evaluate overall survival and transplant-related mortality, among other factors. The study seeks to improve transplant tolerability and outcomes for this vulnerable patient population.

Why it matters

Potential benefit: If successful, this study could enhance the treatment options and outcomes for elderly patients with acute leukemia or myelodysplastic syndromes.

How similar studies have gone: While haploidentical transplants have been commonly applied to younger patients, this specific approach for elderly patients is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients ≥55 years of age and \<70 years of age, with acute leukemia or MDS (with or without HCT-CI≥3);
* Patients eligible for the transplantation of allogeneic hematopoietic stem cells;
* Patients unavailable with HLA matched donors but available with haploidentical donors;
* Voluntary participation in this study and signing the informed consent form.

Exclusion Criteria:

* Patients with the severe infections;
* Pregnant or lactating women or female and male subjects of childbearing age and their spouses who are unable to secure effective contraception during the dosing period and within 90 days after the end of the dosing period.
* Patients who are not eligible for hematopoietic stem cell transplantation;
* Patients who are enrolled in other clinical trials within 1 month;
* Patients who may not be able to complete the study for other reasons, or may be considered by the investigator not suitable to participate in the study;
* Patients unable to properly understand or refusing to accept the informed consent form.

Where it's running

  • Peking University People's Hospital
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.