Comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukemia (ALL), a phase III clinical trial
Phase 3
Completed
- Conditions
- acute lymphoblastic leukemia in children10024324
- Registration Number
- NL-OMON33823
- Lead Sponsor
- Medac
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 198
Inclusion Criteria
Previously untreated T-lineage or percusor B-lineage ALL
Morphological proof of ALL (diagnose established by bone marrow morphology with greater than or equal to 25% blasts)
Age between 1 year and 19 years
Treatment according to DCOG ALL 10 protocol
Written informed consent
Exclusion Criteria
Mature B-lineage ALL
Patients with secondary ALL
Known allergy to any ASNase preparation
General health status according to Karnofsky/Lansky score < 40%
Pre-existing known coalgulopathy (e.e. haemophilia)
Pre-existing pancreatitis
Liver insufficiency (bili >50 umol/l, ALAT/ASAT >10xULN)
Other current malignancies
Pregnacy, breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the rate of patients with complete asparagine depletion in serum<br /><br>during induction treatment; to demonstrate non-inferiority of recombinant<br /><br>versus E-Coli derived Asparaginase Medac. </p><br>
- Secondary Outcome Measures
Name Time Method