Summary

Eligibility
for people ages 22 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

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.

Details

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.

Keywords

Acute Lymphoblastic Leukemia ALL Ph-negative B-cell and T cell ALL Philadelphia-negative ALL Calaspargase Pegol Asparlas Adult Acute Lymphocytic Leukemia Newly diagnosed ALL Untreated ALL Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Calaspargase pegol (S95015)

Eligibility

You can join if…

Open to people ages 22 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UC San Diego Health Moores Cancer Center
    La Jolla California 92093 United States
  • City of Hope Comprehensive Cancer Center
    Duarte California 91010 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Institut de Recherches Internationales Servier
Links
Find Results on Servier Clinical Trial Data website
ID
NCT04817761
Phase
Phase 2/3
Study Type
Interventional
Last Updated