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

Medac

Status and phase

Completed

Phase 2

Conditions

Acute Lymphoid Leukemia

Treatments

Drug: recombinant asparaginase

Study type

Interventional

Funder types

Industry

Identifiers

NCT00983138

EudraCT No: 2008-006300-27

MC-ASP.6/INF

Details and patient eligibility

About

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

Enrollment

12 estimated patients

Sex

All

Ages

Under 364 days old

Volunteers

No Healthy Volunteers

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).