Second Haplo-transplantation for Graft Failure
Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Jul 16, 2024
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new approach to help patients who experience graft failure after their first stem cell transplant. Graft failure means that the body does not accept the transplanted cells, which can lead to serious health problems. In this trial, researchers want to see if a second transplant using cells from a different family member (haploidentical donor) can be safe and effective. They are particularly looking at a method that combines specific medications, fludarabine and cyclophosphamide, to prepare the body for the second transplant.
To participate in this trial, patients must be at least 14 years old and have had graft failure after their first haploidentical stem cell transplant within the last 180 days. They should have a type of blood cancer, such as leukemia or lymphoma. However, patients with active infections, severe organ damage, or other significant health issues may not be eligible. Those who join the study can expect close monitoring and care from the medical team as researchers gather information on how well this new method works for patients facing graft failure.
Gender
ALL
Eligibility 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,
About Peking University People's Hospital
Peking University People's Hospital is a leading clinical research institution in China, renowned for its commitment to advancing medical knowledge and improving patient care through innovative clinical trials. Affiliated with Peking University, the hospital integrates cutting-edge research, comprehensive healthcare services, and a multidisciplinary team of experts to facilitate the development of new therapies and medical interventions. With a strong focus on patient safety and ethical standards, Peking University People's Hospital is dedicated to conducting rigorous clinical trials that contribute to the global medical community and enhance the quality of life for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, Beijing, China
Patients applied
Trial Officials
Xiao-Jun Huang, M.D.
Principal Investigator
Institute of Hematology, Peking University People's Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported