SPARK-ALL: Calaspargase Pegol in Adults With ALL

Sponsor: Institut de Recherches Internationales Servier

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04817761

Patient View

This phase 2/3 study evaluates Calaspargase pegol's safety and pharmacodynamics in adults with Philadelphia-negative ALL. It includes a dose confirmation phase and subsequent treatment at confirmed doses. Eligible participants are aged 22-54, newly diagnosed, with ECOG PS 0-2, and no prior ALL therapy. Dosing varies by age and BMI, with premedication to prevent hypersensitivity.

Patient Parameters

Program Overview

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.

Description

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

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

Get This Program In Your Inbox

You can sign up and apply your patients for this program.