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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.
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.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 in Part 1.
Trial Eligibility
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.
Study Info
Organization
Servier
Primary Outcome
Adverse Events (AEs) (Part 1)
Interventions
Locations Recruiting
HonorHealth Cancer Transplant Institute
United States, Arizona, Scottsdale
City of Hope Comprehensive Cancer Center
United States, California, Duarte
Univeristy of California
United States, California, Los Angeles
University of California Irvine Health (UCI Health)
United States, California, Orange
University of Miami Health System - Sylvester Comprehensive Cancer Center
United States, Florida, Miami
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