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

Hirokazu Nagai, Reiji Fukano, Masahiro Sekimizu, Akiko Kada, Akiko M. Saito, Ryuta Asada, Tetsuya Mori

研究成果: ジャーナルへの寄稿学術論文査読

13 被引用数 (Scopus)

抄録

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.

本文言語英語
ページ(範囲)407-413
ページ数7
ジャーナルNagoya journal of medical science
79
3
DOI
出版ステータス出版済み - 01-08-2017
外部発表はい

All Science Journal Classification (ASJC) codes

  • 医学一般

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