Second haploidentical stem cell transplantation for graft failure
Official title: A Multicenter Prospective Study of Second Haploidentical Transplantation for Graft Failure After the First Haploidentical Transplantation
Run by Peking University People's Hospital · NCT06512519 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 14 Years and up |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | cyclophosphamide, fludarabine |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | June 2026 |
| Study ends | June 2027 |
| Registry record updated | November 7, 2024 |
| Trial ID | NCT06512519 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with active infections, organ dysfunction, or severe comorbidities may 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 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.
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 gone: Previous studies have shown promising results with similar haploidentical transplantation approaches, but this specific protocol requires further validation.
Who can join: the full rules
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 it's running
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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
Similar studies
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This trial tests whether adding venetoclax to a reduced-intensity conditioning regimen is safe for adults with blood cancers who are receiving a combined stem cell and kidney transplant from a matched or partially matched donor.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.