Stopped: Sponsor decision
The purpose of this phase 2/3 study is to confirm the recommended doses and to evaluate the safety and pharmacodynamics of Calaspargase pegol for the treatment of adult patients with Philadelphia-negative Acute Lymphoblastic Leukemia.
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Adverse Events (AEs) (Part 1)
Timeframe: From signing the ICF through 30 days after the Calaspargase pegol administration at Day 4 (or Day 5 or Day 6) in the Remission Induction phase.
Adverse Events (AEs) (Part 2)
Timeframe: From signing the ICF through 30 days after the last dose of the study drug in Delayed Intensification phase.
Plasma Asparaginase Activity (PAA) level (Part 1)
Timeframe: Days 4, 5, 6 (Remission Induction phase) for PAA samples. Days 11, 18, 25 (Remission Induction phase) for TDM samples.
Nadir Plasma Asparaginase Activity (NPAA) (Part 2)
Timeframe: Day 64 (Remission Consolidation Phase).