Bortezomib (Velcade®): a feasibility and phase II study in childhood relapsed acute lymphoblastic leukemia - Bortezomib in relapsed A

Erasmus MC0 个研究点目标入组 24 人开始时间: 2009年8月25日最近更新: 2015年11月16日

适应症

试验速览

暂无简介。

•-Age between 6 months and 19 years
•-patients with a second or subsequent relapsed ALL
•-patients with first relapsed ALL after prior allogeneic stem cell transplantation in first complete remission
•-patients with refractory first relapse of ALL, as defined by the ALL relapse protocol these patienst were enrolled in
•-circulating leukemic blasts of at least 100/ul peripheral blood (i.e. at least 0.1x109/l)
•-patients must take adequate contraceptives when of childbearing potential
•-written informed consent
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-relapse not involving bone marrow
•-symptomatic CNS leukemia
•-Active uncontrolled infection
•-Performance status (Lansky or Karnofsky score) of 60% or less
•-Life expectancy of less than 6 weeks
•-Existing peripheral neuropathy NCI grade 2 or higher
•-Presence of acute diffuse infiltrative and/or pericardial disease
•-Existing clinical signs of cardiotoxicity
•-Previous allogeneic stem cell transplantation within 100 days
•-Pregnant or breastfeeding
•-Other contra-indications for chemotherapy, including no recovery from previous treatment
•-Previous exposure to bortezomib
•-other experimental or conventional antileukemic treatment within 7 days from start of bortezomib
•-alergy to boron and its metabolites
•-no concomitant anti-leukemic therapy other than according to this protocol

发起方