Status:
COMPLETED
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
Lead Sponsor:
medac GmbH
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00784017
Start Date
October 1 2008
End Date
October 1 2012
Last Update
February 27 2013
Active Locations (1)
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1
Erasmus MC
Rotterdam, Netherlands, NL-3015