Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
NCT ID: NCT00784017
Last Updated: 2013-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
199 participants
INTERVENTIONAL
2008-10-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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asparaginase medac
asparaginase
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
recombinant asparaginase
recombinant asparaginase
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
Interventions
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asparaginase
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
recombinant asparaginase
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
18 Years
ALL
No
Sponsors
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medac GmbH
INDUSTRY
Responsible Party
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Locations
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Erasmus MC
Rotterdam, , Netherlands
Countries
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References
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van der Sluis IM, de Groot-Kruseman H, Te Loo M, Tissing WJE, van den Bos C, Kaspers GJL, Bierings M, Kollen WJW, Konig T, Pichlmeier U, Kuhnel HJ, Pieters R. Efficacy and safety of recombinant E. coli asparaginase in children with previously untreated acute lymphoblastic leukemia: A randomized multicenter study of the Dutch Childhood Oncology Group. Pediatr Blood Cancer. 2018 Aug;65(8):e27083. doi: 10.1002/pbc.27083. Epub 2018 May 4.
Other Identifiers
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MC-ASP.5/ALL
Identifier Type: -
Identifier Source: org_study_id
EudraCT number 2006-003180-31
Identifier Type: -
Identifier Source: secondary_id
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