Spots Global Cancer Trial Database for Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)
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Trial Identification
Brief Title: 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 ID: NCT00983138
Conditions
Interventions
Study Description
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:
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Hospital Charité Virchow, Berlin, , Germany
University Hospital Bonn, Bonn, , Germany
University Hospital Erlangen, Erlangen, , Germany
University Hospital Essen, Essen, , Germany
University Hospital Johann Wolfgang Goethe, Frankfurt, , Germany
University Hospital Freiburg, Freiburg, , Germany
University Hospital Hamburg-Eppendorf, Hamburg, , Germany
Medical University Hannover, Hannover, , Germany
University Hospital Schleswig-Holstein, Campus Kiel, Kiel, , Germany
University Hospital Münster, Münster, , Germany
Olga Hospital, Stuttgart, , Germany
VU University Medical Centre, Amsterdam, , Netherlands
Academic Medical Centre AMC/EK2, Amsterdam, , Netherlands
University of Groningen, Groningen, , Netherlands
University Children's Hospital Nijmegen, Nijmegen, , Netherlands
Sophia Children's Hospital, Rotterdam, , Netherlands
University Medical Centre Utrecht, Utrecht, , Netherlands
Contact Details
Name: Rob Pieters, MD
Affiliation: Erasmus MC-Sophia Children's Hospital
Role: PRINCIPAL_INVESTIGATOR
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