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
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- KADA AKIKO
- Clinical Research Center, National Hospital Organization Nagoya Medical Center
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- KIKUTA ATSUSHI
- Department of Pediatric Oncology, Fukushima Medical University Hospital
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- SAITO AKIKO M.
- Clinical Research Center, National Hospital Organization Nagoya Medical Center
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- KATO KOJI
- Department of Hematology and Oncology, Children’s Medical Center, Japanese Red Cross Nagoya First Hospital
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- IGUCHI AKIHIRO
- Department of Pediatrics, Hokkaido University Hospital
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- YABE HIROMASA
- Department of Cell Transplantation and Regenerative Medicine, Tokai University School of Medicine
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- ISHIDA HIROYUKI
- Department of Pediatrics, Kyoto City Hospital
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- HYAKUNA NOBUYUKI
- Department of Pediatrics, University of the Ryukyus Hospital
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- TAKAHASHI YOSHIYUKI
- Department of Pediatrics/Developmental Pediatrics, Nagoya University Graduate School of Medicine
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- NAGASAWA MASAYUKI
- Department of Pediatrics, Japanese Red Cross Musashino Hospital
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- HASHII YOSHIKO
- Department of Pediatrics, Osaka University Graduate School of Medicine
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- UMEDA KATSUTSUGU
- Department of Pediatrics, Kyoto University Hospital
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- MATSUMOTO KIMIKAZU
- Children's Cancer Center, National Center for Child Health and Development
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- FUJISAKI HIROYUKI
- Department of Pediatrics Hematology/Oncology, Osaka City General Hospital
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- YANO MICHIHIRO
- Department of Pediatrics, Akita University Hospital
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- NAKAZAWA YOZO
- Department of Pediatrics, Shinshu University School of Medicine
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- SANO HIDEKI
- Department of Pediatric Oncology, Fukushima Medical University Hospital
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<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>
収録刊行物
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- The Kurume Medical Journal
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The Kurume Medical Journal advpub (0), 161-168, 2021-08-20
久留米大学医学部 The Kurume Medical Journal 編集部
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詳細情報
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- CRID
- 1390007624812520448
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- NII論文ID
- 130008101718
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- ISSN
- 18812090
- 00235679
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- PubMed
- 34421094
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- Crossref
- PubMed
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