Phase 2 multicenter study of pegaspargase in Japanese patients with previously untreated acute lymphoblastic leukemia.

ABSTRACT: Pegaspargase is a pegylated formulation of E. coli-derived asparaginase, which when combined with multi-agent chemotherapy is an effective, well-established therapy for acute lymphoblastic leukemia (ALL). This study evaluated the efficacy, safety and pharmacokinetics of lyophilized pegaspargase in the Japanese population. The study had two parts; the primary endpoint for Part 1 was the incidence and nature of treatment-emergent adverse events (TEAEs), including those related to pegaspargase, to determine the number of patients who experience intolerable toxicity during a tolerability assessment period. The primary endpoint for Part 2 was the percentage of patients with plasma asparaginase activity of ≥ 0.1 IU/ml 14 days after administration of the first dose of lyophilized pegaspargase. Al

SUBMITTER: Koh K 

PROVIDER: S-EPMC12304028 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature