再発または難治性急性リンパ性白血病の日本人小児患者におけるクロファラビンに関する研究

基本情報

NCT ID

NCT01196013

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

7

治験依頼者名

Sanofi

概要

The purpose of this study is primarily to assess the safety, tolerability and pharmacokinetics (PK) of clofarabine intravenously administered to pediatric patients with relapsed or refractory acute lymphoblastic leukemia (ALL) or for whom no other therapy with greater potential clinical benefit exists. The dosing regimen for the intravenous (IV) clofarabine is 30 or 52 mg/m2/day for 5 consecutive days. The secondary objectives are to document the activity of clofarabine and to explore the impact of deoxycytidine kinase (dCK) promoter polymorphism on PK and treatment outcome.

対象疾患

介入

依頼者（Sponsor）

実施施設 (9)