Haploidentical stem cell transplantation for acute leukemia
Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia
Peking University People's Hospital · NCT03756675
This study is testing a new way of using stem cells from donors to see if it can help people with acute leukemia recover better and avoid complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 2 Years to 60 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital (other) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT03756675 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and efficacy of haplotype peripheral blood stem cell transplantation (PBSCT) for patients with acute leukemia. Utilizing the GIAC protocol, the study involves treating donors with granulocyte colony-stimulating factor (G-CSF) to enhance immune tolerance and prevent graft-versus-host disease (GVHD). The study aims to assess the outcomes of using G-CSF-mobilized peripheral blood stem cells compared to traditional bone marrow sources, focusing on engraftment rates and disease-free survival. Participants will be monitored for their response to the treatment and any associated complications.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 2-60 years in the first complete remission phase of acute leukemia who are planning to receive haplotype PBSCT.
Not a fit: Patients with uncontrolled infections, organ failure, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with acute leukemia.
How similar studies have performed: Previous studies have shown promising results with similar haploidentical stem cell transplantation approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 2-60 years old, all genders; * the first complete remission phase (CR1) of acute leukemia; * planning to receive haplotype PBSCT; * no uncontrolled current infections (new infections, body temperature still above 38 ℃ after treatment with broad-spectrum antibiotics for 72h, except for other non-infectious factors); * no organ failure. Exclusion Criteria: * with poor compliance; * with uncontrolled current infections； * pregnancy; * donors with contraindications of mobilization and collection of peripheral blood stem cells; * with mental sickness
Where this trial is running
Beijing, Beijing
- Peking University People's Hospital — Beijing, Beijing, China (RECRUITING)
Study contacts
- Principal investigator: Xiao-Jun Huang, MD — Peking University People's Hospital
- Study coordinator: Yu Wang, MD
- Email: ywyw3172@sina.com
- Phone: 13552647384
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.
Conditions: Acute Leukemia, allogeneic stem cell transplantation, G-CSF-mobilized peripheral blood stem cell, haplotype