Evaluating a gentler transplant approach for older patients with leukemia
Reduced Intensity Conditioning Regimen for Elderly or High Comorbidity Burden Patients Receiving Haploidentical Hematopoietic Stem Cell Transplantation
This study is testing a gentler transplant method for older patients with leukemia to see if it helps them live longer and have fewer complications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT03412409 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a reduced intensity conditioning (RIC) regimen for elderly patients or those with high comorbidity burden undergoing haploidentical hematopoietic stem cell transplantation (haplo-HSCT). The study focuses on patients over 55 years old or those with a hematopoietic cell transplantation-specific comorbidity index (HCT-CI) score of 3 or higher. The primary goal is to reduce transplant-related mortality (TRM) and improve overall survival rates. Secondary endpoints include disease-free survival, relapse rates, engraftment success, and the incidence of graft-versus-host disease (GVHD) and infections, with a follow-up period of one year.
Who should consider this trial
Good fit: Ideal candidates are patients over 55 years old or those with a HCT-CI score of 3 or higher who are receiving haplo-HSCT without an identical sibling or unrelated donor.
Not a fit: Patients with active infections, organ failure, or those who have identical sibling or unrelated donors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of transplant-related mortality and improve survival outcomes for elderly and high-comorbidity patients.
How similar studies have performed: Other studies have shown promise with reduced intensity conditioning regimens in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients older than 55 years or those with HCT-CI scores of ≥3, without ISD nor URD, receiving haplo-HSCT Exclusion Criteria: * patients having identical sibling or unrelated donors; patients with active infection; patients having organ failure; patients with poor compliance.
Where this trial is running
Beijing
- Peking University, Institute of Hematolgoy — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Xiao-Jun Huang — Institute of Hematology, Peking University
- Study coordinator: Xiao-Dong Mo, MD
- Email: mxd453@163.com
- Phone: 8610-8832-6001
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.