Status:
COMPLETED
Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)
Lead Sponsor:
medac GmbH
Conditions:
Acute Lymphoid Leukemia
Eligibility:
All Genders
Up to 364 years
Phase:
PHASE2
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-l...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00983138
Start Date
July 1 2009
End Date
February 1 2011
Last Update
March 1 2011
Active Locations (17)
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1
Hospital Charité Virchow
Berlin, Germany, 13353
2
University Hospital Bonn
Bonn, Germany, 53113
3
University Hospital Erlangen
Erlangen, Germany, 91054
4
University Hospital Essen
Essen, Germany, 45147