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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Administration of 1-7 doses of 150 IU/kg IV infusion. (every 2 weeks for a maximum of 4 doses and every 6 weeks for maximum 3 doses).
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
Tallinn, Estonia
Tartu University Clinics
Tartu, Estonia
Childrens Hospital, Helsinki. University Central Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
...and 13 more locations
Pharmacokinetics ASNase Activity >100 U/L at 14 Days
The primary endpoint was the percentage of patients with ASNase activity \>100 U/L at 14 days following the first infusion (nadir). ASNase activity \>100 U/L is considered adequate for complete asparagine depletion in the blood.
Time frame: 14 days after first infusion
Pharmacokinetic Parameters
Percentage of patients with ASNase activity \>100 U/L at 14 days following the fourth infusion of the 2-week dosing intervals. ASNase activity \>100 U/L is considered adequate for complete asparagine depletion in the blood.
Time frame: 14 days after fourth infusion
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