A Multi-center Open-label Single-arm Phase 2/3 Trial Evaluating the Safety and Pharmacokinetics of Calaspargase Pegol for Treatment of Adults Aged 22 To >65 Years with Newly-diagnosed Philadelphia-negative ALL

Brief description of study

The purpose of the study is to optimize the dosage of calaspargase pegol in newly-diagnosed Philadelphia-negative acute lymphoblastic leukemia (ALL) patients based on age. We want to know the safety of calaspargase pegol and efficacy of calaspargase pegol as a replacement for pegaspargase in combined with multi-agent chemotherapy. The Food and Drug Administration approved calaspargase pegol-mknl (CALASP), an asparagine-specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years and now we are testing it in patients above age of 21. Dose will be dependent on age and we will monitor closely serum asparaginase (SAA) levels.

Clinical Study Identifier: s20-01203
ClinicalTrials.gov Identifier: NCT04817761

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