NCT03267030

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

Single-Arm PharmacoKinetic/PharmacoDynamic and Safety Study of Eryaspase (GRASPA®) for Patients With Hypersensitivity to PEG-Asparaginase, Diagnosed With Ph(-) Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Birgitte Klug Albertsen · Academic / Other
• Sex: All
• Age: 1 Year – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	GRASPA	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).

Timeline

• Start date: 2017-08-23
• Primary completion: 2020-08-01
• Completion: 2020-10-22
• First posted: 2017-08-30
• Last updated: 2024-03-15
• Results posted: 2024-03-15

Locations

23 sites across 6 countries: Denmark, Estonia, Finland, Lithuania, Norway, Sweden