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Single-Arm Non-Blinded Multicenter Clinical Trial on T-Cell-Replete Haploidentical Stem Cell Transplantation Using Low-Dose Antithymocyte Globulin for Relapsed and Refractory Pediatric Acute Leukemia

  • KADA AKIKO
    Clinical Research Center, National Hospital Organization Nagoya Medical Center
  • KIKUTA ATSUSHI
    Department of Pediatric Oncology, Fukushima Medical University Hospital
  • SAITO AKIKO M.
    Clinical Research Center, National Hospital Organization Nagoya Medical Center
  • KATO KOJI
    Department of Hematology and Oncology, Children’s Medical Center, Japanese Red Cross Nagoya First Hospital
  • IGUCHI AKIHIRO
    Department of Pediatrics, Hokkaido University Hospital
  • YABE HIROMASA
    Department of Cell Transplantation and Regenerative Medicine, Tokai University School of Medicine
  • ISHIDA HIROYUKI
    Department of Pediatrics, Kyoto City Hospital
  • HYAKUNA NOBUYUKI
    Department of Pediatrics, University of the Ryukyus Hospital
  • TAKAHASHI YOSHIYUKI
    Department of Pediatrics/Developmental Pediatrics, Nagoya University Graduate School of Medicine
  • NAGASAWA MASAYUKI
    Department of Pediatrics, Japanese Red Cross Musashino Hospital
  • HASHII YOSHIKO
    Department of Pediatrics, Osaka University Graduate School of Medicine
  • UMEDA KATSUTSUGU
    Department of Pediatrics, Kyoto University Hospital
  • MATSUMOTO KIMIKAZU
    Children's Cancer Center, National Center for Child Health and Development
  • FUJISAKI HIROYUKI
    Department of Pediatrics Hematology/Oncology, Osaka City General Hospital
  • YANO MICHIHIRO
    Department of Pediatrics, Akita University Hospital
  • NAKAZAWA YOZO
    Department of Pediatrics, Shinshu University School of Medicine
  • SANO HIDEKI
    Department of Pediatric Oncology, Fukushima Medical University Hospital

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Abstract

<p>Summary: Although approximately 70% of pediatric hematological malignancies are curable, approximately 30% remain fatal. No standard treatment is available in patients showing relapse and those with refractory disease. Although different methods are adopted in different hospitals, its efficacy is extremely limited. In recent years, haploidentical stem cell transplantation, involving high-dose cyclophosphamide administration post-transplanta tion, has been used, mainly in adults; however, its application is limited to removal of alloreactive T cells. Multicenter single-arm clinical trials of T-cell replete haploidentical stem cell transplantation (TCR-haplo-SCT) will be conducted in children with relapsed and refractory acute leukemia. After myeloablative conditioning using total body irradiation or busulfan, intensive graft versus host disease prophylaxis is administered, consisting of low-dose rabbit anti-human thymocyte globulin, tacrolimus, methotrexate, and prednisolone. An external control group is set up for the study. The treatment period is around 3 months, and the follow-up period is 2 years from transplantation completion.</p><p>The aim of this study is to verify the efficacy and safety of TCR-haplo-SCT and present it as a new immune cell therapy for improving survival rate in children with relapsed and refractory acute leukemia.</p>

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