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

NCT ID: NCT01856803

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2019-06-30

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.

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.

Conditions

Leukemia, GVHD, ATG, Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

routine prophylaxis

In this group, CSA plus MMF and MTX adopted as prevention of GVHD.

Group Type: ACTIVE_COMPARATOR

anti thymoglobulin

Intervention Type: DRUG

ATG prophylaxis

In this group,ATG+MMF+CsA+MTX was adopted as prevention of GVHD

Group Type: EXPERIMENTAL

anti thymoglobulin

Intervention Type: DRUG

Interventions

anti thymoglobulin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaojun Huang,MD

director of peking university institute of hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking university people's hospital

Beijing, Beijing Municipality, China

Countries

China

References

Chakupurakal G, Freudenberger P, Skoetz N, Ahr H, Theurich S. Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults. Cochrane Database Syst Rev. 2023 Jun 21;6(6):CD009159. doi: 10.1002/14651858.CD009159.pub3.

Reference Type: DERIVED

PMID: 37341189 (View on PubMed)

Chang YJ, Wu DP, Lai YR, Liu QF, Sun YQ, Hu J, Hu Y, Zhou JF, Li J, Wang SQ, Li W, Du X, Lin DJ, Ren HY, Chen FP, Li YH, Zhang X, Huang H, Song YP, Jiang M, Hu JD, Liang YM, Wang JB, Xiao Y, Huang XJ. Antithymocyte Globulin for Matched Sibling Donor Transplantation in Patients With Hematologic Malignancies: A Multicenter, Open-Label, Randomized Controlled Study. J Clin Oncol. 2020 Oct 10;38(29):3367-3376. doi: 10.1200/JCO.20.00150. Epub 2020 Jul 10.

Reference Type: DERIVED

PMID: 32650683 (View on PubMed)

Other Identifiers

2013-08

Identifier Type: -

Identifier Source: org_study_id