for people ages 22-55 (full criteria)
at Orange, California and other locations
study started
completion around



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.


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.


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)


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.


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


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
Institut de Recherches Internationales Servier
Find Results on Servier Clinical Trial Data website
Phase 2/3 research study
Study Type
Expecting 122 study participants
Last Updated