Evaluating Haplo-HSCT for Elderly Patients with Acute Leukemia or Myelodysplastic Syndrome
Clinical Registration Study of Haploidentical Stem Cell Transplantation for Elderly Patients With Acute Leukemia or Myelodysplastic Syndrome
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 55 Years to 70 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05902416 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 55 to 70 with acute leukemia or myelodysplastic syndromes who lack HLA-matched donors.
Not a fit: Patients with severe infections or those not eligible for hematopoietic stem cell transplantation will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Sun
- Email: sunyuqian83@hotmail.com
- Phone: 01088326666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.