Anti-thymocyte Globulins for GVHD Prophylaxis After HLA-matched Sibling Stem Cell Transplantation in Patients at 40 Years of Age or More With Hematological Malignancies
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 able to take medication after engraftment. The dosage was adjusted to
maintain a trough blood level of 200-300ng/ml. MMF was administered orally, 0.25g every 12
hours, from day -1 before transplantation to day 30 after transplantation. The dosage of MTX
was 15 mg/m2, administered i.v. on day 1, and 10 mg/m2 on days 3, 6, and 11 after
transplantation. ATG (Thymoglobulin 2.5mg/kg per day i.v.) on days -2 through -1. In the
control 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 able to take medication after
engraftment. The dosage was adjusted to maintain a trough blood level of 200-300ng/ml. MMF
was administered orally, 0.25g every 12 hours, from day -1 before transplantation to day 30
after transplantation. The dosage of MTX was 15 mg/m2, administered i.v. on day 1, and 10
mg/m2 on days 3, 6, and 11 after transplantation.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Incidence of acute GVHD, and chronic GVHD
2 years
Yes
China: Food and Drug Administration
2013-08
NCT01856803
March 2013
March 2016
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