Status:
ACTIVE_NOT_RECRUITING
SPARK-ALL: Calaspargase Pegol in Adults With ALL
Lead Sponsor:
Institut de Recherches Internationales Servier
Collaborating Sponsors:
ADIR, a Servier Group company
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
22-55 years
Phase:
PHASE2
PHASE3
Brief 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-nega...
Detailed 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 or recommended in Part 1.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 9 2026
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04817761
Start Date
July 7 2021
End Date
February 9 2026
Last Update
October 9 2025
Active Locations (19)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
Univeristy of California
Los Angeles, California, United States, 90095
3
University of California Irvine Health (UCI Health)
Orange, California, United States, 92868
4
University of Miami Health System - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136