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

ENROLLING
Protocol # :
21-272
Conditions
Acute Lymphoblastic Leukemia
Phase
II/III
Disease Sites
Other Hematopoietic
Lymphoid Leukemia
Principal Investigator
DeAngelo, Daniel, J

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.

21-272