EUCTR2009-010826-20-FR进行中（未招募）不适用
A phase I dose escalation study of clofarabine given in combination with multi-agent therapy for remission induction in pediatric patients with acute lymphoblastic leukemia in first relapse or refractory to first line therapy – VANDEVOL Study - vandevol
Centre Hospitalier Régional et Universitaire de Lille0 个研究点目标入组 20 人开始时间: 2009年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age des patients entre 1 et 21 ans au moment du diagnostic initial de leucémie aiguë lymphoblastique.
- •Score de Lansky > 60; ou Karnofsky >70
- •Absence d’autre maladie maligne.
- •Absence d’infection non contrôlée
- •Fonctions rénales et hépatiques normales (créatinine et bilirubine <= 2 la limite supérieure de la normale).
- •Absence de maladie cardiovasculaire sévère
- •Fraction de raccourcissement du ventricule gauche supérieure ou égale à 30%, ou fraction d’éjection supérieure ou égale à 60%
- •absence d’atteinte pulmonaire sévère (CTC grade III-IV)
- •Absence de maladie neurologique ou psychiatrique sévère concomitante.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Autre maladie sévère
- •Allogreffe médullaire de moins de 6 mois
- •Atteinte sévère hépatique, rénale, cardiovasculaire, neurologique concomitante
- •Trisomie 21
- •Grossesse ou allaitement
- •Administration de tout autre médicament en cours d’expérimentation concomitante ou dans les trois semaines précédant l’inclusion
研究者
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