Asparaginase Encapsulated in Erythrocytes for Patients With ALL and Hypersensitivity to PEG-asparaginase
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|ClinicalTrials.gov Identifier: NCT03267030|
Recruitment Status : Completed
First Posted : August 30, 2017
Last Update Posted : January 25, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: GRASPA||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 23, 2017|
|Actual Primary Completion Date :||August 1, 2020|
|Actual Study Completion Date :||October 22, 2020|
GRASPA will replace remaining PEG-asparaginase doses in case of hypersensitivity.
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).
Other Name: Eryaspase
- Pharmacokinetic parameters [ Time Frame: 6 months ]Enzyme activity (IU/L)
- Pharmacokinetic parameters [ Time Frame: 6 months ]T1/2 (half-life time)
- Pharmacokinetic parameters [ Time Frame: 6 months ]Area under the plasma concentration versus time curve (AUC)
- Pharmacokinetic parameters [ Time Frame: 6 months ]Vss (Distribution Volume at steady state)
- Pharmacokinetic parameters [ Time Frame: 6 months ]Mean Residence Time (MRT)
- Pharmacodynamic profile [ Time Frame: 6 months ]
Plasma concentrations of amino acids: asparagine, aspartate, glutamine, glutamate
o Concentrations of amino acids in the cerebrospinal fluid (CSF): (asparagine, aspartate, glutamine, glutamate)
- Immunogenicity [ Time Frame: 6 months ]Titers of anti-asparaginase antibodies and neutralizing antibodies
- Incidence of hypersensitivity [ Time Frame: 6 months ]allergic reactions (any grade) and silent inactivation
- Incidence of toxicity [ Time Frame: 6 months ]Incidence of Treatment-emergent adverse events
- Interactions with maintenance therapy [ Time Frame: 6 months ]Measurement of levels of maintenance metabolites from the maintenance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267030
|Principal Investigator:||Brigitte Klug Albertsen, MD, PhD||Pediatric and adolescent medicine, Aarhus University Hospital, Denmark|