For Healthcare Professionals

Calaspargase Pegol in Adults With ALL

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. 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).
  2. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2.
  3. 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

Exclusion Criteria:

  1. Patients with Philadelphia chromosome positive ALL, Burkitt's leukemia, mixed lineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia per WHO classification (2016).
  2. Patients with Down syndrome.
  3. Patients with Hepatitis B (positive for HBs antigen), and Hepatitis C (HCV antibody) at inclusion
  4. Participants known to be HIV-positive.
  5. Known history of non-gallstone-related pancreatitis.
  6. Known severe hepatic impairment (bilirubin >3 x upper limit of normal [ULN]; transaminases >10 times ULN.
  7. Pre-existing history of hepatic veno-occlusive disease (VOD).
  8. Age ≥ 55 years.
  9. BMI > 35 kg/m2.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Acute Lymphoblastic Leukemia

Age (in years)

22 - 55

Phase

Phase 2/Phase 3

Participants needed

122

Est. Completion Date

Aug 31, 2026

Treatment type

Interventional


Sponsor

Servier

ClinicalTrials.gov identifier

NCT04817761

Study number

CL2-95015-001

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