Status:
COMPLETED
Anti-thymocyte Globulins for Graft-versus-host Disease Prophylaxis
Lead Sponsor:
Peking University People's Hospital
Conditions:
Leukemia, GVHD, ATG, Transplantation
Eligibility:
All Genders
40-60 years
Phase:
PHASE4
Brief Summary
Age is a risk factor for graft-versus-host disease (GVHD) after human leukocyte antigen (HLA)-matched sibling allogeneic stem cell transplantation (allo-SCT). The incidence of acute GVHD is significan...
Detailed Description
Prophylaxis for GVHD included CSA, MTX and MMF±ATG. In the trial group, CSA was started intravenously on day -1, at the dosage of 3 mg/kg, and switched to oral formulation as soon as the patient was a...
Eligibility Criteria
Inclusion
- Standard-risk of recipients with hematological malignancies (including AML-CR1, ALL-CR1, CML-CP, MDS-RA, RARS,RCMD,RAEB-1); age from 40 to 60; having HLA-matched sibling donor; Eastern Cooperative Oncology Group (ECOG)≤1, ejection fraction (EF)≥50%; bilirubin≤35µmol/L; AST, and ALT lower than or equall to two-fold baseline;creatinie≤130µmol/L.
Exclusion
- Active, uncontrolled infection; severe allergy to ATG, including shock or laryngeal edema; secondary stem cell transplant recipient; haplidentical recipients; matched unrelated donor recipients; non-myeloablative condioning regimen recipients; EF\<50%; bilirubin\>35µmol/L; AST, and ALT higher than two-fold baseline; creatinie\>130µmol/L.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01856803
Start Date
October 1 2013
End Date
June 1 2019
Last Update
September 25 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking university people's hospital
Beijing, Beijing Municipality, China, 100044