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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)