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Low-dose anti-thymocyte globulin for GVHD prophylaxis in HLA-matched allogeneic peripheral blood stem cell transplantation

Bone Marrow Transplantation volume 56, pages 129–136 (2021)Cite this article

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Abstract

Allogeneic peripheral blood stem cell transplantation (PBSCT) is associated with an increased risk of severe acute and chronic graft-versus-host disease (GVHD) compared to bone marrow transplantation. Anti-thymocyte globulin (ATG) can reduce severe acute and chronic GVHD in PBSCT; however, an optimal dose of ATG remains undefined. We conducted a multicenter phase II study to investigate safety and efficacy of low-dose ATG (a total of 2 mg/kg Thymoglobulin) in patients undergoing HLA-matched PBSCT after myeloablative conditioning. The primary endpoint was grades III–IV GVHD at 100 days. Seventy-seven patients were enrolled and 72 patients with a median age of 46.5 years were eligible for analysis. The primary endpoint, cumulative incidence of grades III–IV acute GVHD at 100 days was 1.4% (95% CI, 0.1–6.7%), which was greatly less than our pre-defined statistical threshold value (18.0%). The incidence of chronic GVHD at 1 year was also low (all-grade; 15.3%, moderate to severe; 5.6%). Non-relapse mortality, relapse, overall survival, disease-free survival, and GVHD-free, relapse-free survival at 1 year were 4.2%, 20.8%, 84.7%, 75.0%, and 69.4%, respectively. Low dose thymoglobulin is promising to reduce severe acute and chronic GVHD in HLA-matched PBSCT following myeloablative conditioning.

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Fig. 1: Cumulative incidences of GVHD.
Fig. 2: Transplant outcomes.

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Acknowledgements

This work was in supported by grants from North Japan Hematology Study Group, and the Japan Agency for Medical Research and Development (AMED, 19ek0510025h0002).

Japan Study Group for Cell Therapy and Transplantation (JSCT)

Masahiro Imamura14, Shuichi Taniguchi15, Chihiro Shimazaki16, Shinji Nakao17, Mitsune Tanimoto18, Kenji Imajo19, Koichi Akashi20, Takanori Teshima21, Takashi Okamura22, Koji Nagafuji23, Toshihiro Miyamoto20, Yuju Ohno24, Takahiro Fukuda25, Tetsuya Eto26, Morio Matsumoto27, Hirokazu Okumura28, Tohru Murayama29, Kazutaka Sunami30, Naoki Kobayashi14, Naoyuki Uchida15, Yoshinobu Kanda31, Hideki Tsujimura32, Koji Kato20, Yasushi Takamatsu33, Junichi Sugita21, Michihiro Hidaka34, Yuichiro Nawa35, Mine Harada36

Author information

Authors and Affiliations

  1. Department of Hematology, Hokkaido University Hospital, Sapporo, Japan

    Souichi Shiratori, Junichi Sugita & Takanori Teshima

  2. Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan

    Shuichi Ota

  3. Department of Hematology, Gifu Municipal Hospital, Gifu, Japan

    Senji Kasahara

  4. Department of Hematology, Osaka International Cancer Institute, Osaka, Japan

    Jun Ishikawa

  5. Department of Hematology, Kanagawa Cancer Center, Yokohama, Japan

    Takayoshi Tachibana

  6. Department of Hematology, Osaka City General Hospital, Osaka, Japan

    Yoshiki Hayashi

  7. Department of Hematology/Oncology, Kyushu University Hospital, Fukuoka, Japan

    Goichi Yoshimoto

  8. Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan

    Tetsuya Eto

  9. Department of Hematology and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan

    Hiromi Iwasaki

  10. Karatsu Higashimatsuura Medical Center, Karatsu, Japan

    Mine Harada

  11. Division of Cancer Epidemiology and prevention, Aichi Cancer Center Research Institute, Nagoya, Japan

    Keitaro Matsuo

  12. Division of Cancer Epidemiology and prevention, Nagoya University Graduate Medicine, Nagoya, Japan

    Keitaro Matsuo

  13. Department of Hematology, Hokkaido University faculty of medicine, Sapporo, Japan

    Takanori Teshima

  14. Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan

    Masahiro Imamura & Naoki Kobayashi

  15. Department of Hematology, Toranomon Hospital, Tokyo, Japan

    Shuichi Taniguchi & Naoyuki Uchida

  16. Department of Hematology, Japan Community Health Care Organization, Kyoto, Japan

    Chihiro Shimazaki

  17. Department of Hematology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan

    Shinji Nakao

  18. Department of Hematology and Oncology, Okayama University, Okayama, Japan

    Mitsune Tanimoto

  19. Department of Internal Medicine, Okayama City Hospital, Okayama, Japan

    Kenji Imajo

  20. Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan

    Koichi Akashi, Toshihiro Miyamoto & Koji Kato

  21. Department of Hematology, Graduate School of Medicine, Hokkaido University Faculty of Medicine, Sapporo, Japan

    Takanori Teshima & Junichi Sugita

  22. Hematology and Oncology Center, St. Mary’s Hospital, Kurume, Japan

    Takashi Okamura

  23. Department of Hematology, Kurume University Hospital, Kurume, Japan

    Koji Nagafuji

  24. Department of Internal Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan

    Yuju Ohno

  25. Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan

    Takahiro Fukuda

  26. Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan

    Tetsuya Eto

  27. Department of Hematology, National Hospital Organization Nishigunma National Hospital, Shibukawa, Japan

    Morio Matsumoto

  28. Department of Internal Medicine (Hematology), Toyama Prefectural Central Hospital, Toyama, Japan

    Hirokazu Okumura

  29. Department of Hematology, Hyogo Cancer Center, Akashi, Japan

    Tohru Murayama

  30. Department of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan

    Kazutaka Sunami

  31. Division of Hematology, Jichi Medical University Saitama Medical Center, Saitama, Japan

    Yoshinobu Kanda

  32. Division of Hematology-Oncology, Chiba Cancer Center, Chiba, Japan

    Hideki Tsujimura

  33. Division of Medical Oncology, Hematology and Infectious Diseases, Fukuoka University Hospital, Fukuoka, Japan

    Yasushi Takamatsu

  34. Department of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan

    Michihiro Hidaka

  35. Department of Hematology, Ehime Prefectural Central Hospital, Matsuyama, Japan

    Yuichiro Nawa

  36. Karatsu Higashimatsuura Medical Center, Karatsu, Japan

    Mine Harada

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  1. Souichi Shiratori
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on behalf of the Japan Study Group for Cell Therapy and Transplantation (JSCT)

  • Masahiro Imamura
  • , Shuichi Taniguchi
  • , Chihiro Shimazaki
  • , Shinji Nakao
  • , Mitsune Tanimoto
  • , Kenji Imajo
  • , Koichi Akashi
  • , Takanori Teshima
  • , Takashi Okamura
  • , Koji Nagafuji
  • , Toshihiro Miyamoto
  • , Yuju Ohno
  • , Takahiro Fukuda
  • , Tetsuya Eto
  • , Morio Matsumoto
  • , Hirokazu Okumura
  • , Tohru Murayama
  • , Kazutaka Sunami
  • , Naoki Kobayashi
  • , Naoyuki Uchida
  • , Yoshinobu Kanda
  • , Hideki Tsujimura
  • , Koji Kato
  • , Yasushi Takamatsu
  • , Junichi Sugita
  • , Michihiro Hidaka
  • , Yuichiro Nawa
  •  & Mine Harada

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Correspondence to Takanori Teshima.

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TT has received research funds from Sanofi.

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Members of the Japan Study Group for Cell Therapy and Transplantation (JSCT) are listed below Acknowledgements.

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Shiratori, S., Sugita, J., Ota, S. et al. Low-dose anti-thymocyte globulin for GVHD prophylaxis in HLA-matched allogeneic peripheral blood stem cell transplantation. Bone Marrow Transplant 56, 129–136 (2021). https://doi.org/10.1038/s41409-020-0985-3

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