SPARK-ALL: Calaspargase Pegol in Adults with ALL

Inclusion Criteria:

• Aged ≥22 and <55 years with newly-diagnosed and cytologically confirmed anddocumented 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 signingthe informed consent except for limited treatment (≤7 days) with corticosteroids orhydroxyurea and a single dose of intrathecal cytarabine.

Exclusion Criteria:

• Patients with Philadelphia chromosome positive ALL, Burkitt's leukemia, mixedlineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia per WHOclassification (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 >10 times ULN.

• Pre-existing history of hepatic veno-occlusive disease (VOD).

• Age ≥ 55 years.

• BMI > 35 kg/m2.