Comparative pharmacokinetics, pharmacodynamics, efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukemia (ALL).
Completed
- Registration Number
- NL-OMON24878
- Lead Sponsor
- Medac Research
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
Inclusion Criteria
1. Previously untreated ALL;
2. Moprhological proof of ALL; bone marrow > 25%blasts;
Exclusion Criteria
1. Known allergy to ASNase;
2. General health status according to Karnofsky/Lansky <40%;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the ratio of the population geometric means of the 72 hour serum concentration versus time curves (AUC) for the first administration of recombinant asparaginase versus Asparaginase medac.
- Secondary Outcome Measures
Name Time Method 1. Trough levels of ASNase activity in serum during subsequent ASNase infusions;<br /><br>2. Serum and CSF levels of asparagine, aspartic acid, glutamine, glutamic acid;<br /><br>3. CR rate and MRD status at day 33;<br /><br>4. Adverse events.