Spots Global Cancer Trial Database for Asparaginase Encapsulated in Erythrocytes for Patients With ALL and Hypersensitivity to PEG-asparaginase
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Trial Identification
Brief Title: Asparaginase Encapsulated in Erythrocytes for Patients With ALL and Hypersensitivity to PEG-asparaginase
Official Title: Single-Arm PharmacoKinetic/PharmacoDynamic and Safety Study of Eryaspase (GRASPA®) for Patients With Hypersensitivity to PEG-Asparaginase, Diagnosed With Ph(-) Acute Lymphoblastic Leukemia
Study ID: NCT03267030
Conditions
Interventions
Study Description
Brief Summary: Pegylated-asparaginase (PEG-ASP) is an important part of the treatment of childhood acute lymphoblastic leukaemia (ALL). Unfortunately 13% of patients develops allergy and further treatment is impossible. Furthermore, 6% of patients have developed antibodies (silent inactivation) and have no effect of the PEG-ASP treatment. Truncated asparaginase therapy is associated with inferior event-free survival outcomes, in particular relapse in central nervous system (CNS). Eryaspase is a new formulation of asparaginase encapsulated in erythrocytes. The erythrocyte membrane protects asparaginase against fast degradation and elimination processes. The encapsulation eliminates the direct somatic contact, and it is hypothesized that this provides the potential to prolong the activity of the enzyme and reduce toxicities.
Detailed Description:
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aahus University hospial, hematological department, Aarhus, Aarhus C, Denmark
Aarhus University hospital, Aarhus, Aarhus N, Denmark
Aalborg University Hospital, pediatric department, Aalborg, , Denmark
Rigshospitalet, Hematological department, Copenhagen, , Denmark
Rigshospitalet, Child and Adolescent Medicine, Copenhagen, , Denmark
Odense University hospital, pediatric department, Odense, , Denmark
Tallin Childrens Hospital, Tallin, , Estonia
Tartu University Clinics, Tartu, , Estonia
Childrens Hospital, Helsinki. University Central Hospital, Helsinki, , Finland
Kuopio University Hospital, Kuopio, , Finland
University Hospital of Oulu, Oulu, , Finland
Tampere University Hospital, Tampere, , Finland
Turku University Hospital, Turku, , Finland
Vilnius University Children's Hospital, Vilnius, , Lithuania
Helse Bergen, Bergen, , Norway
Oslo Universitetssykehus, Rikshospitalet, Oslo, , Norway
St Olavs Hospital, Trondheim, , Norway
Drottning Silvias Barn- och ungdomssjukhus, Göteborg, , Sweden
Universitetssjukhuset Linköping, Linköping, , Sweden
Skånes Universitets sjukhus, Lund, , Sweden
Astrid Lindgrens Barnsjukhus Karolinska, Stockholm, , Sweden
arn- och Ungdomscentrum Norrlands Universitetssjukhus, Umeå, , Sweden
Akademiska sjukhuset Uppsala, Uppsala, , Sweden
Contact Details
Name: Brigitte Klug Albertsen, MD, PhD
Affiliation: Pediatric and adolescent medicine, Aarhus University Hospital, Denmark
Role: PRINCIPAL_INVESTIGATOR
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