Calaspargase Pegol in Adults With ALL

a study on Acute Lymphoblastic Leukemia Leukemia Lymphoma

Summary

Eligibility
for people ages 22-55 (full criteria)
Location
at UC Irvine UCLA
Dates
study started
completion around

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, Lymphoid Leukemia, Calaspargase pegol (S95015)

Eligibility

You can join if…

Open to people ages 22-55

  • 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.

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.
  • Pre-existing history of hepatic veno-occlusive disease (VOD).
  • Age ≥ 55 years.
  • BMI > 35 kg/m2.

Locations

  • Univeristy of California accepting new patients
    Los Angeles California 90095 United States
  • University of California Irvine Health (UCI Health) not yet accepting patients
    Orange California 92868 United States
  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new 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 research study
Study Type
Interventional
Participants
Expecting 122 study participants
Last Updated