Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia

Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia

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

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