Modified second transplantation for patients with graft failure
Second Haploidentical Transplantation with Modified Regimen for Graft Failure After the First Allogeneic Stem Cell Transplantation
This study is testing a new approach to a second stem cell transplant for patients who didn't fully recover after their first transplant to see if it helps them get better, especially with their platelet counts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06512545 on ClinicalTrials.gov |
What this trial studies
This study investigates a modified regimen for second allogeneic stem cell transplantation in patients who have experienced graft failure after their first transplant. The aim is to enhance hematopoietic reconstitution and improve recovery outcomes, particularly focusing on patients who have not fully recovered their platelet counts. It is a prospective, single-arm study that evaluates the safety and efficacy of this new approach. The study includes patients with hematological malignancies who meet specific eligibility criteria.
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 allogeneic 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 significantly improve recovery rates and outcomes for patients suffering from graft failure after stem cell transplantation.
How similar studies have performed: Previous studies have shown encouraging results with similar approaches, but this specific modified regimen is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Primary disease: hematological malignancies(AML, CML, MDS, lymphoma, etc.); 2.Graft failure after first allogeneic 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.