This study is in progress, not accepting new patients

SPARK-ALL: Calaspargase Pegol in Adults with ALL

a study on Acute Lymphoblastic Leukemia Leukemia Lymphoma

Eligibility: for people ages 22-55 (full criteria)
Location: at Orange, California and other locations
Dates: study started July 2021
completion around February 2026

Description

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-negative Acute Lymphoblastic Leukemia.

Official Title

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.

Details

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.

Keywords

Acute Lymphoblastic Leukemia, ALL, Ph-negative B-cell and T cell ALL, Philadelphia-negative ALL, Calaspargase Pegol, Asparlas, Adult, Acute Lymphocytic Leukemia, Newly diagnosed ALL, Untreated ALL, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoid Leukemia, Calaspargase pegol (S95015)

Eligibility

You can join if…

Open to people ages 22-55

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 CAN'T join 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.

Locations

University of California Irvine Health (UCI Health)
Orange California 92868 United States
Univeristy of California
Los Angeles California 90095 United States

Details

Status: in progress, not accepting new patients
Start Date: July 2021
Completion Date: February 2026 (estimated)
Sponsor: Institut de Recherches Internationales Servier
Links: Find Results on Servier Clinical Trial Data website
ID: NCT04817761
Phase: Phase 2/3 research study
Study Type: Interventional
Participants: Expecting 122 study participants
Last Updated: February 26, 2025