Second Haplo-transplantation for Graft Failure

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Jul 16, 2024

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,