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
Trial Description
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.
Eligibility Requirements
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.