Clinical trial · Interventional
Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)
Efficacy and Safety of Recombinant Asparaginase in Infants (<1 Year) With Previously Untreated Acute Lymphoblastic Leukaemia - Phase II Clinical Trial
NCT00983138CI-TRIAL-00004491completedPhase 2ClinicalTrials.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 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
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 Lymphoid Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant asparaginase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- recombinant asparaginase
- interventionNames
- Drug: recombinant asparaginase
Primary outcomes (1)
- measure
- number of patients with hypersensitivity reactions to rASNase
- timeFrame
- within 2 months
Secondary outcomes (1)
- measure
- pharmacodynamic of rASNase
- timeFrame
- within 33 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 364 Days
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.