Acute Lymphoid Leukemia
Conditions
Brief summary
This non-controlled multicentre phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase (rASNase) for first-line treatment of infants (\< 1 year of age at diagnosis) with de novo acute lymphoblastic leukaemia
Interventions
10 000 Units/m² adjusted to age, 6 i.v. infusions (day 15, day 18, day 22, day 25, day 29, day 33) during the induction therapy
Sponsors
medac GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 364 Days
Healthy volunteers
No
Inclusion criteria
* Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia according to EGIL criteria. * Morphological verification of the diagnosis, confirmed with cyto¬chemistry and immunophenotyping. * Age \< 1 year at diagnosis. * Written informed consent of the parents or other legally authorised guardian of the patient. * Treatment according to protocol INTERFANT 06
Exclusion criteria
* Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL. * The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells. * Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible. * Known allergy to any ASNase preparation. * Pre-existing known coagulopathy (e.g. haemophilia). * Pre-existing pancreatitis. * Liver insufficiency (bilirubin \> 50 µmol/L; SGOT/SGPT \> 10 x the upper limit of normal).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of patients with hypersensitivity reactions to rASNase | within 2 months |
Secondary
| Measure | Time frame |
|---|---|
| pharmacodynamic of rASNase | within 33 days |
Countries
Germany, Netherlands
Outcome results
None listed