Open
Actively Recruiting
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
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
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Study Stats
Protocol No.
22-000963
Category
Leukemia
Principal Investigator
Contact
Location
- UCLA Westwood