SPARK-ALL: Calaspargase Pegol in Adults With ALL

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2/Phase 3

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

22 Years

Maximum Age

55 Years

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.