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Clinical Trials

Influence of two different doses of antithymocyte globulin in patients with standard-risk disease following haploidentical transplantation: a randomized trial

Bone Marrow Transplantation volume 49, pages 426–433 (2014)Cite this article

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Abstract

To evaluate the effect of the different doses of antithymocyte globulin (ATG) on the incidence of acute GVHD among patients receiving hematopoietic SCT without ex vivo T-cell-depletion from haploidentical donors, 224 patients with standard-risk hematological malignancy were randomized in this study. One hundred and twelve patients received 6 mg/kg ATG, whereas the remaining patients received 10 mg/kg ATG. This study was registered at http://www.chictr.org as No. ChiCTR-TRC-11001761. The incidence of grade III–IV acute GVHD was higher in the ATG-6 group (16.1%, 95% confidence interval (CI), 9.1–23.1%) than in the ATG-10 group (4.5%, CI, 0.7–8.3%, P=0.005, 95% CI for the difference, −19.4% to −3.8%). EBV reactivation occurred more frequently in the ATG-10 group (25.3%, 17.1–33.5%) than in the ATG-6 group (9.6% (4.0–15.2%), P=0.001). The 1-year disease-free survival rates were 84.3% (77.3–91.3%) and 86.0% (79.2–92.8%) for the ATG-6 group and ATG-10 groups, respectively (P=0.88). In conclusion, although 6 mg/kg ATG applied in haploidentical transplantation decreased the risk of EBV reactivation compared with 10 mg/kg ATG, this treatment exposes patients to a higher risk for severe acute GVHD.

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Acknowledgements

This work was supported (in part) by the National High Technology Research and Development Program of China (Program 863) (Grant No. 2011AA020105), The Key Program of National Natural Science Foundation of China (Grant No. 81230013), the Scientific Research Foundation for Capital Medicine Development (Grant No. 2011-4022-08) and the National Natural Science Foundation of China (Grant Nos. 30971292 and 30725038). We thank American Journal Experts for reviewing the paper in English. We thank every faculty member who has participated in these studies.

Author contributions

XJH designed and performed the study. YW and HXF collected data. YW and XJH did the data analysis and wrote the paper. All the authors contributed to the interpretation of the data and approved the final version.

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Authors and Affiliations

  1. Peking University People’s Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Beijing, China

    Y Wang, H-X Fu, D-H Liu, L-P Xu, X-H Zhang, Y-J Chang, Y-H Chen, F-R Wang, Y-Q Sun, F-F Tang, K-Y Liu & X-J Huang

  2. Peking-Tsinghua Center for Life Sciences, Beijing, China

    X-J Huang

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Wang, Y., Fu, HX., Liu, DH. et al. Influence of two different doses of antithymocyte globulin in patients with standard-risk disease following haploidentical transplantation: a randomized trial. Bone Marrow Transplant 49, 426–433 (2014). https://doi.org/10.1038/bmt.2013.191

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