Actively Recruiting
Second Haplo-transplantation for Graft Failure
Led by Peking University People's Hospital · Updated on 2024-11-07
34
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
P
Peking University People's Hospital
Lead Sponsor
T
The First Affiliated Hospital of Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. There are no recommended regimens for second transplantations for graft failure, especially in the haploidentical transplant setting. We recently reported encouraging outcomes using a novel method (haploidentical transplantation from a different donor after conditioning with fludarabine and cyclophosphamide). However, the study was performed in single-center and with very small sample size. Therefore, it should be further validated via multicenter study. In this multi-center study, we aim to further evaluate the safety and efficacy of this protocol.
CONDITIONS
Official Title
Second Haplo-transplantation for Graft Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hematological malignancies such as AML, CML, MDS, or lymphoma
- Graft failure after the first haploidentical stem cell transplantation
- Time between first and second transplantation less than 180 days
- Age 14 years or older
You will not qualify if you...
- Active infections at the time of enrollment
- Active graft-versus-host disease
- Significant organ dysfunction including liver injury (total bilirubin greater than 2 times upper limit normal), kidney injury (creatinine greater than 1.5 times upper limit normal), or heart issues (ejection fraction less than 50% or symptomatic heart failure)
- Eastern Cooperative Oncology Group (ECOG) performance score greater than 2
- Expected lifespan less than 30 days
- Inability to cooperate with study procedures
- Any other condition deemed inappropriate for enrollment by the investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
Yu-qian Sun, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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