Bortezomib (Velcade®): A feasibility and phase II study in childhood relapsed acute lymphoblastic leukemia
- Conditions
- acute lymphobastic leukemiawhite blood cell cancer10024324
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
- 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
- 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
- no concomitant anti-leukemic therapy other than according to this protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Antileukemic activity of bortezomib when added to dexamethasone and vincristine<br /><br>and intrathecal methotrexate, as determined by the absolute peripheral blood<br /><br>(PB) blast count on day 8 of treatment. Morphology will be centrally reviewed.</p><br>
- Secondary Outcome Measures
Name Time Method