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

niversity Hospital Ghent0 个研究点目标入组 29 人开始时间: 2012年7月25日最近更新: 2022年1月24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 patients were enrolled in begore
•- 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: 1
•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
•- allergy to boron and its metabolites
•- concomitant anti-leukemic therapy other than according to this protocol

发起方

niversity Hospital Ghent