SPARK-ALL: Calaspargase Pegol in Adults With ALL

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.

Inclusion Criteria: * Aged ≥22 with newly-diagnosed and cytologically confirmed and documented Philadelphia-negative B-cell or T-cell ALL by World Health Organization (WHO) classification (2016). * Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. * No prior therapy for ALL such as chemotherapy and radiation therapy before signing the informed consent except for limited treatment (≤7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine. Exclusion Criteria: * Patients with Philadelphia chromosome positive ALL, Burkitt's leukemia, mixed lineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia per WHO classification (2016). * Patients with Down syndrome. * Patients with Hepatitis B (positive for HBs antigen), and Hepatitis C (HCV antibody) at inclusion * Participants known to be HIV-positive. * Known history of non-gallstone-related pancreatitis. * Known severe hepatic impairment (bilirubin \>3 x upper limit of normal \[ULN\]; transaminases \>5 times ULN (unless suspected leukemic involvement of the liver). * Pre-existing history of hepatic veno-occlusive disease (VOD). * BMI \> 35 kg/m2 (This criterion was introduced as an amendment for Part 2)