SPARK-ALL: Calaspargase Pegol in Adults With ALL

Stopped early · Phase 2/Phase 3

Conditions studied: Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT04817761

Run by

Institut de Recherches Internationales Servier

People needed

42

Starts

2021-07-07

Expected to finish

2025-03-21

Last updated by the study team

2026-02-18

Who can join

Age: 22 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• HonorHealth Cancer Transplant Institute — Scottsdale, Arizona, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Univeristy of California — Los Angeles, California, United States
• University of California Irvine Health (UCI Health) — Orange, California, United States
• University of Miami Health System - Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• University of Kansas Cancer Center - Richard and Annette Bloch Cancer Care Pavilion — Westwood, Kansas, United States
• University of Maryland Greenbaum Cancer Center — Baltimore, Maryland, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Weymouth, Massachusetts, United States
• Northwell Health Cancer Institute — Lake Success, New York, United States
• NYU Langone/Laura and Isaac Perlmutter Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Health & Science University (OHSU) — Portland, Oregon, United States
• Jefferson Health — Philadelphia, Pennsylvania, United States
• Baptist Clinical Research Institute — Memphis, Tennessee, United States
• Intermountain Healthcare (IHC) — Salt Lake City, Utah, United States
• University of Washington/Seattle Cancer Care Alliance/Fred Hutch — Seattle, Washington, United States
• West Virginia University Cancer Institute — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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