SPARK-ALL: Calaspargase Pegol in Adults With ALL

SPARK-ALL: 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.

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.

The study will be conducted in 2 parts. Part 1 is a dose confirmation run-in period. Part 2 will enroll the remaining participants at the dose as confirmed or recommended in Part 1.

Inclusion Criteria:

• Aged ≥22 and <55 years 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 >10 times ULN.
• Pre-existing history of hepatic veno-occlusive disease (VOD).
• Age ≥ 55 years.
• BMI > 35 kg/m2.