Clinical trial · Interventional
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
NCT00784017CI-TRIAL-00009583completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| asparaginase | Drug | Asparaginase | ALIAS |
| recombinant asparaginase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- asparaginase medac
- interventionNames
- Drug: asparaginase
- type
- EXPERIMENTAL
- label
- recombinant asparaginase
- interventionNames
- Drug: recombinant asparaginase
Primary outcomes (1)
- measure
- 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
- timeFrame
- March 2012
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDvan 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 29727043