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
Treatment
Study Type
Interventional
Phase
Phase II/III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
22 Years
Maximum Age
N/A

Inclusion Criteria:

  • Aged ≥22 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.

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
22-000963
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04817761
For detailed technical eligibility, visit ClinicalTrials.gov.