Acute Lymphoblastic Leukemia
Conditions
Keywords
Children with previously untreated acute lymphoblastic leukemia
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
Interventions
DRUGasparaginase
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33
Sponsors
medac GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment | March 2012 |
Countries
Netherlands
Outcome results
None listed