Clinical trial NCT00983138: Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)
Official title: Efficacy and Safety of Recombinant Asparaginase in Infants (<1 Year) With Previously Untreated Acute Lymphoblastic Leukaemia - Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoid Leukemia
Lead sponsor: medac GmbH
Sponsor class: INDUSTRY
First posted: 2009-09-23
Enrollment: 12
Sex: ALL
Maximum age (years): 364
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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).

Primary outcomes:
measure: number of patients with hypersensitivity reactions to rASNase
timeFrame: within 2 months
Secondary outcomes:
measure: pharmacodynamic of rASNase
timeFrame: within 33 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hospital Charité Virchow
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Erlangen
country: Germany
facility: University Hospital Erlangen
city: Essen
country: Germany
facility: University Hospital Essen
city: Frankfurt
country: Germany
facility: University Hospital Johann Wolfgang Goethe
city: Freiburg
country: Germany
facility: University Hospital Freiburg
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medical University Hannover
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Kiel
city: Münster
country: Germany
facility: University Hospital Münster
city: Stuttgart
country: Germany
facility: Olga Hospital
city: Amsterdam
country: Netherlands
facility: VU University Medical Centre
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre AMC/EK2
city: Groningen
country: Netherlands
facility: University of Groningen
city: Nijmegen
country: Netherlands
facility: University Children's Hospital Nijmegen
city: Rotterdam
country: Netherlands
facility: Sophia Children's Hospital
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
Study officials:
affiliation: Erasmus MC-Sophia Children's Hospital
name: Rob Pieters, MD
role: PRINCIPAL_INVESTIGATOR
References: