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SPARK-ALL: 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.


Description

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.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.

Trial Eligibility

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.

Study Info

Organization

Servier


Primary Outcome

Adverse Events (AEs) (Part 1)


Outcome Timeframe From signing the ICF through 30 days after the Calaspargase pegol administration at Day 4 (or Day 5 or Day 6) in the Remission Induction phase.

NCTID NCT04817761

Phases PHASE2,PHASE3

Primary Purpose TREATMENT

Start Date 2021-07-07

Completion Date 2027-02-03

Enrollment Target 122

Interventions

DRUG Calaspargase pegol (S95015)

Locations Recruiting

HonorHealth Cancer Transplant Institute

United States, Arizona, Scottsdale


City of Hope Comprehensive Cancer Center

United States, California, Duarte


Univeristy of California

United States, California, Los Angeles


University of California Irvine Health (UCI Health)

United States, California, Orange


University of Miami Health System - Sylvester Comprehensive Cancer Center

United States, Florida, Miami


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