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日本人白血病またはリンパ腫患者におけるネララビン(506U78)の臨床評価
基本情報
- NCT ID
- NCT00406757
- ステータス
- 完了
- 試験のフェーズ
- 第1相
- 試験タイプ
- 介入
- 目標被験者数
- 13
- 治験依頼者名
- GlaxoSmithKline
概要
In Japan, patients with relapsed or refractory T-ALL/T-LBL represent an extremely small patient population. While the small number of patients presents a practical limitation to the size of a clinical trial, patients whose disease has not responded to or has relapsed after treatment with multiple prior chemotherapy regimens have no accepted standard therapies available. Japanese leukemia experts have expressed interest in evaluating 506U78 in Japanese patients with relapsed or refractory T-ALL/T-LBL. In order to obtain safety, tolerability, and pharmacokinetic data of 506U78 in Japanese patients, this study is designed to maximize the contribution of each available patient.
対象疾患
Leukaemia, Lymphoblastic, Acute and Lymphoma, Lymphoblastic
介入
Nelarabine injection 400mg/m2(DRUG)
Nelarabine injection 650mg/m2(DRUG)
Nelarabine injection 1000mg/m2(DRUG)
Nelarabine injection 1500mg/m2(DRUG)
依頼者(Sponsor)
グラクソ・スミスクライン株式会社(INDUSTRY)