Anti-thymocyte Globulins for Graft-versus-host Disease Prophylaxis
Information source: Peking University People's Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia, GVHD, ATG, Transplantation
Intervention: anti thymoglobulin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Peking University People's Hospital Overall contact: Ying-Jun Chang, MD,PhD, Phone: 86-10-88324671, Email: pk200608@126.com
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 significantly higher in patients at 40 years of age or more than those at 18
to 39 years of age after allo-SCT. It was found that Anti-thymocyte globulins can be used
for prophylaxis of both acute and chronic GVHD after allo-SCT. Prophylaxis of GVHD using ATG
in patients at 40 years of age or more in matched sibling allo-SCT settings might
significantly decrease the incidence of acute and chronic GVHD and the incidence of late
effect after transplantation.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Incidence of acute GVHD, and chronic GVHD
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 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.
Eligibility
Minimum age: 40 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Ying-Jun Chang, MD,PhD, Phone: 86-10-88324671, Email: pk200608@126.com
Peking university people's hospital, Beijing, Beijing 100044, China; Recruiting ying-jun chang, MD,PHD, Email: pk200608@126.com Xiao-jun huang, MD,PhD, Principal Investigator
Additional Information
Starting date: October 2013
Last updated: May 13, 2015
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