Asparaginase is a critical agent in the treatment of ALL. This enzyme deaminates asparagine, interfering with protein synthesis and resulting in cell death as lymphoblasts are deficient in asparagine synthetase. Eryaspase is a dispersion of homologous red blood cells (RBCs) encapsulating L-asparaginase formulated in a preservative solution for infusion. The formulation of eryaspase has evolved during its development. Two sources of L-asparaginase (drug substance) from Medac GmbH can be used as raw material and encapsulated in the RBCs: native (Kidrolase®) or recombinant L-asparaginase (Spectrila®). This study is designed to investigate the PK comparability of both eryaspase formulations: native or recombinant asparaginase as the starting material, when administered as monotherapy and in combination with chemotherapy during induction and consolidation phases for the treatment of children and young adults presenting with ALL/LBL.
This is a multicenter, multinational, double-blind, randomized, parallel group Phase 2 study of patients with de novo or relapsed ALL/LBL. After obtaining informed consent and performance of screening procedures, patients will be randomized to receive either eryaspase-N or eryaspase-R. Major Inclusion: Male or female, aged between 1-55 years Confirmed diagnosis of Philadelphia chromosome negative ALL/LBL, de novo or first relapse Adequate Performance Status Major Exclusion: Second intention asparaginase treatment in first-line setting. (These are patients who develop hypersensitivity reactions to another asparaginase and require switch to a different asparaginase formulation to complete the intended course of therapy) Refractory ALL/LBL (failure to achieve complete remission in first-line treatment) Recruitment will continue until 38 patients with a PK evaluable profile are enrolled.
Clinical trial identification
Legal entity responsible for the study
N. Soule: Employed by Erytech Pharma. C. Holford, R. Kay: Consultant at Erytech Pharma. D. Tilton: Employed by Erytech Pharma. N. Biswas-Baldwin: Employee of Erytech Pharma. I. El Hariry: Employed by Erytech Pharma and have stock ownership.