Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
Phase 3
Completed
- Conditions
- Acute Lymphoblastic Leukemia
- Interventions
- Registration Number
- NCT00784017
- Lead Sponsor
- medac GmbH
- Brief Summary
This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 199
Inclusion Criteria
- Previously untreated T-lineage or precursor B-lineage ALL
- Patients must have morphological proof of ALL and diagnosis must be made from bone marrow morphology with more than 25% blasts
- Written informed consent
- Treatment according to DCOG ALL 10 protocol
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 coagulopathy (e.g. haemophilia)
- Pre-existing pancreatitis
- Liver insufficiency (Bilirubin > 50 µmol/L; SGOT/SGPT > 10 x ULN)
- Other current malignancies
- Pregnancy (planned or existent), breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description recombinant asparaginase recombinant asparaginase - asparaginase medac asparaginase -
- Primary Outcome Measures
Name Time Method To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter March 2012
- Secondary Outcome Measures
Name Time Method To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment March 2012
Trial Locations
- Locations (1)
Erasmus MC
🇳🇱Rotterdam, Netherlands