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  1. C100 医学部/医学系研究科
  2. C100b 紀要
  3. Nagoya journal of medical science
  4. 79(3)

Phase II trial of CH5424802 (alectinib hydrochloride) for recurrent or refractory ALK-positive anaplastic large cell lymphoma : study protocol for a non-randomized non-controlled trial

https://doi.org/10.18999/nagjms.79.3.407
https://doi.org/10.18999/nagjms.79.3.407
2e314791-7904-4cb5-afef-f617d0e899ef
名前 / ファイル ライセンス アクション
13_Nagai.pdf 13_Nagai.pdf (263.5 kB)
Item type 紀要論文 / Departmental Bulletin Paper(1)
公開日 2017-08-24
タイトル
タイトル Phase II trial of CH5424802 (alectinib hydrochloride) for recurrent or refractory ALK-positive anaplastic large cell lymphoma : study protocol for a non-randomized non-controlled trial
著者 Nagai, Hirokazu

× Nagai, Hirokazu

WEKO 73274

Nagai, Hirokazu

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Fukano, Reiji

× Fukano, Reiji

WEKO 73275

Fukano, Reiji

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Sekimizu, Masahiro

× Sekimizu, Masahiro

WEKO 73276

Sekimizu, Masahiro

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Kada, Akiko

× Kada, Akiko

WEKO 73277

Kada, Akiko

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Saito, Akiko M.

× Saito, Akiko M.

WEKO 73278

Saito, Akiko M.

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Asada, Ryuta

× Asada, Ryuta

WEKO 73279

Asada, Ryuta

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Mori, Tetsuya

× Mori, Tetsuya

WEKO 73280

Mori, Tetsuya

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キーワード
主題Scheme Other
主題 phase II trial
キーワード
主題Scheme Other
主題 anaplastic large cell lymphoma
キーワード
主題Scheme Other
主題 efficacy
キーワード
主題Scheme Other
主題 safety
抄録
内容記述 Currently, a standard therapy has not been established for recurrent or refractory anaplastic lymphoma kinase-positive anaplastic large cell lymphoma. While there are many treatment options, such as hematopoietic stem cell transplantation, patients with resistant disease to conventional chemotherapies have particularly poor prognosis. There is urgent need to develop new drugs because of the lack of a standard therapy and poor prognoses. This phase II trial is designed for evaluating the efficacy and safety of alectinib hydrochloride for patients with recurrent or refractory anaplastic lymphoma kinase -positive anaplastic large cell lymphoma. The primary endpoint is the response rate according to the Revised Response Criteria for Malignant Lymphoma. The secondary endpoints are pharmacokinetics, safety in children, complete response rate, response duration, progression-free survival, event-free survival, overall survival, and adverse events. The results of this trial will be the pivotal data for the drug approval of alectinib hydrochloride for recurrent or refractory anaplastic lymphoma kinase-positive anaplastic large cell lymphoma.
内容記述タイプ Abstract
出版者
出版者 Nagoya University Graduate School of Medicine, School of Medicine
言語
言語 eng
資源タイプ
資源 http://purl.org/coar/resource_type/c_6501
タイプ departmental bulletin paper
ID登録
ID登録 10.18999/nagjms.79.3.407
ID登録タイプ JaLC
ISSN(print)
収録物識別子タイプ ISSN
収録物識別子 0027-7622
書誌情報 Nagoya Journal of Medical Science

巻 79, 号 3, p. 407-413, 発行日 2017-08
著者版フラグ
値 publisher
URI
識別子 http://www.med.nagoya-u.ac.jp/medlib/nagoya_j_med_sci/793.html
識別子タイプ URI
URI
識別子 http://hdl.handle.net/2237/26918
識別子タイプ HDL
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