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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: medac GmbH
• Treatments: Asparaginase

Criteria

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