Overview

Calaspargase Pegol in Adults With ALL

Status:
Recruiting
Trial end date:
2025-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institut de Recherches Internationales Servier
Collaborator:
ADIR, a Servier Group company
Criteria
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.