Second haploidentical stem cell transplantation for graft failure
A Multicenter Prospective Study of Second Haploidentical Transplantation for Graft Failure After the First Haploidentical Transplantation
This study is testing if a second stem cell transplant from a partially matched donor can help patients with blood cancers who had problems with their first transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | cyclophosphamide, fludarabine |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06512519 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of a second haploidentical stem cell transplantation for patients who have experienced graft failure after their first transplant. The approach involves using a different donor and conditioning with fludarabine and cyclophosphamide. The trial aims to validate previous encouraging outcomes observed in a small, single-center study by expanding to a multicenter setting. Eligible participants include those with hematological malignancies who meet specific criteria related to their condition and timing of the second transplant.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14 and older with hematological malignancies who have experienced graft failure within 180 days of their first haploidentical stem cell transplantation.
Not a fit: Patients with active infections, organ dysfunction, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients suffering from graft failure after stem cell transplantation.
How similar studies have performed: Previous studies have shown promising results with similar haploidentical transplantation approaches, but this specific protocol requires further validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Primary disease: hematological malignancies (AML, CML, MDS, lymphoma, etc.); 2. Graft failure after the first haploidentical stem cell transplantation; 3. Time from the first transplantation to the second transplantation is less than 180 days; 4. Age≥14 years. Exclusion Criteria: * 1\. Active infections; 2. Active GVHD; 3. Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%\<50% or symptomatic heart failure); 4. Eastern Cooperative Oncology Group (ECOG) score\>2; 5. Expected life time\<30 days; 5. Patients could not cooperate; 6. Other situations that are considered inappropriate for enrollment by the investigators,
Where this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xiao-Jun Huang, M.D. — Institute of Hematology, Peking University People's Hospital
- Study coordinator: Yu-qian Sun, M.D.
- Email: sunyuqian83@hotmail.com
- Phone: +86-10-88324577
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.