GRASPA (Erythrocytes Encapsulating L-asparaginase) in Patients With Relapse of Acute Lymphoblastic Leukemia
Status:
Completed
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
Summary
Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by
toxicities including hypersensitivity. Clinical allergy is associated with inactivation of
asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any
clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics,
tolerability and maintain circulating asparaginase activity due to the protective barrier of
the erythrocyte membrane.
This study is run to confirm the benefit/risk profile of GRASPA at 150 IU/kg in combination
with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without
known hypersensitivity to L-asparaginase.