Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: medac GmbH
• Treatments: Asparaginase

Criteria

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).