Bortezomib trial for the treatment of childhood relapsed acute lymphoblastic leukemia
- Conditions
- acute lymphoblastic leukemiaMedDRA version: 14.1Level: LLTClassification code 10063625Term: Acute lymphoblastic leukemia recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-014037-25-DK
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
-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: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 2
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method