SPARK-ALL: Calaspargase Pegol in Adults With ALL

Más betegség

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

Laborértékek

• Known severe hepatic impairment (bilirubin >3 x upper limit of normal [ULN]; transaminases >5 times ULN (unless suspected leukemic involvement of the liver).

Egyéb

• Patients with Philadelphia chromosome positive ALL, Burkitt's leukemia, mixed lineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia per WHO classification (2016).
• BMI > 35 kg/m2 (This criterion was introduced as an amendment for Part 2)

• 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.