DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017