drugset / Trial / NCT03267030

Asparaginase Encapsulated in Erythrocytes for Patients With ALL and Hypersensitivity to PEG-asparaginase

NCT03267030

Phase 2 Completed 55 enrolled Birgitte Klug Albertsen ERYtech Pharma · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-08-23
Primary completion
2020-08-01
Completion
2020-10-22

Drugs

EvaluationDrugModalityDoseRoute
Subject GRASPA Protein / enzyme biologic 150 iu/kg Intravenous