論文

査読有り
2020年5月

Phase I study of brentuximab vedotin (SGN-35) in Japanese children with relapsed or refractory CD30-positive Hodgkin's lymphoma or systemic anaplastic large cell lymphoma.

International journal of hematology
  • Yuhki Koga
  • ,
  • Masahiro Sekimizu
  • ,
  • Akihiro Iguchi
  • ,
  • Akiko Kada
  • ,
  • Akiko M Saito
  • ,
  • Ryuta Asada
  • ,
  • Tetsuya Mori
  • ,
  • Keizo Horibe

111
5
開始ページ
711
終了ページ
718
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1007/s12185-020-02820-1

Data on the treatment of pediatric patients with brentuximab vedotin are limited. The aims of the present study were to assess the safety and tolerability of brentuximab vedotin in Japanese children with relapsed or refractory Hodgkin's lymphoma (HL) or systemic anaplastic large-cell lymphoma (sALCL). Pediatric patients, aged 2-17 years, with relapsed or refractory HL or sALCL were recruited. Brentuximab vedotin were administered at 1.8 mg/kg via intravenous infusion once every 3 weeks. Primary endpoints were dose-limiting toxicity and safety. Between September 2016, and March 2018, six patients (median age 11.5, range 5-14 years), four with relapsed or refractory HL and two with relapsed or refractory sALCL were enrolled. Dose limiting toxicity was not observed in any of the six patients. Although three of six patients (50%) experienced at least one grade ≥ 3 adverse event, no patient experienced a serious adverse event. The pharmacokinetic profile of brentuximab vedotin in pediatric patients was comparable to that reported in adults. The proportion of patients who achieved overall response was 60% (95% confidence interval 14.7-94.7). Brentuximab vedotin at 1.8 mg/kg once every 3 weeks was considered tolerable in children with relapsed or refractory HL or sALCL.

リンク情報
DOI
https://doi.org/10.1007/s12185-020-02820-1
PubMed
https://www.ncbi.nlm.nih.gov/pubmed/31960285

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