Clinical trial · Interventional
Anti-thymocyte Globulins for Graft-versus-host Disease Prophylaxis
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, GVHD, ATG, Transplantation | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti thymoglobulin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- routine prophylaxis
- description
- In this group, CSA plus MMF and MTX adopted as prevention of GVHD.
- interventionNames
- Drug: anti thymoglobulin
- type
- EXPERIMENTAL
- label
- ATG prophylaxis
- description
- In this group,ATG+MMF+CsA+MTX was adopted as prevention of GVHD
- interventionNames
- Drug: anti thymoglobulin
Primary outcomes (1)
- measure
- Incidence of acute GVHD, and chronic GVHD
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDChakupurakal 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. PMID 37341189
- DERIVEDChang 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. PMID 32650683