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

Phase 2

Completed

• Conditions: Acute Lymphoid Leukemia
• Interventions: Drug: recombinant asparaginase

• Registration Number: NCT00983138
• Lead Sponsor: medac GmbH

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Status Verified: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-02-28
• Last Update Posted: 2011-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
recombinant asparaginase	recombinant asparaginase	-

Primary Outcome Measures

Name	Time	Method
number of patients with hypersensitivity reactions to rASNase	within 2 months

Secondary Outcome Measures

Name	Time	Method
pharmacodynamic of rASNase	within 33 days

Trial Locations

Locations (17)

University Hospital Erlangen; 🇩🇪 Erlangen, Germany

Sophia Children's Hospital; 🇳🇱 Rotterdam, Netherlands

University Hospital Bonn; 🇩🇪 Bonn, Germany

University Hospital Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Germany

Medical University Hannover; 🇩🇪 Hannover, Germany

University Hospital Münster; 🇩🇪 Münster, Germany

Hospital Charité Virchow; 🇩🇪 Berlin, Germany

University Hospital Freiburg; 🇩🇪 Freiburg, Germany

Academic Medical Centre AMC/EK2; 🇳🇱 Amsterdam, Netherlands

University of Groningen; 🇳🇱 Groningen, Netherlands

University Children's Hospital Nijmegen; 🇳🇱 Nijmegen, Netherlands

University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

University Medical Centre Utrecht; 🇳🇱 Utrecht, Netherlands

University Hospital Johann Wolfgang Goethe; 🇩🇪 Frankfurt, Germany

Olga Hospital; 🇩🇪 Stuttgart, Germany

VU University Medical Centre; 🇳🇱 Amsterdam, Netherlands

University Hospital Essen; 🇩🇪 Essen, Germany