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Anti-thymocyte Globulins for Graft-versus-host Disease Prophylaxis

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ClinicalTrials.gov Identifier: NCT01856803
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaojun Huang,MD, Peking University People's Hospital

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 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.

Condition or disease Intervention/treatment Phase
Leukemia, GVHD, ATG, Transplantation Drug: anti thymoglobulin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : October 2013
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2019

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Arm Intervention/treatment
Active Comparator: routine prophylaxis
In this group, CSA plus MMF and MTX adopted as prevention of GVHD.
Drug: anti thymoglobulin
Experimental: ATG prophylaxis
In this group,ATG+MMF+CsA+MTX was adopted as prevention of GVHD
Drug: anti thymoglobulin



Primary Outcome Measures :
  1. Incidence of acute GVHD, and chronic GVHD [ Time Frame: 2 years ]


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856803


Locations
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China, Beijing
Peking university people's hospital
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xiaojun Huang,MD, director of peking university institute of hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01856803    
Other Study ID Numbers: 2013-08
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Thymoglobulin
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents