Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
2 other identifiers
interventional
199
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2008
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 31, 2008
CompletedFirst Posted
Study publicly available on registry
November 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFebruary 27, 2013
February 1, 2013
4 years
October 31, 2008
February 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment
March 2012
Study Arms (2)
asparaginase medac
ACTIVE COMPARATORrecombinant asparaginase
EXPERIMENTALInterventions
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- medac GmbHlead
Study Sites (1)
Erasmus MC
Rotterdam, NL-3015, Netherlands
Related Publications (1)
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.
PMID: 29727043DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2008
First Posted
November 3, 2008
Study Start
October 1, 2008
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
February 27, 2013
Record last verified: 2013-02