Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Institut de Recherches Internationales Servier
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.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Aged ≥22 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 be 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 \>5 times ULN (unless suspected leukemic involvement of the liver).
Pre-existing history of hepatic veno-occlusive disease (VOD).
BMI \> 35 kg/m2 (This criterion was introduced as an amendment for Part 2)
Clareo Health | SPARK-ALL: Calaspargase Pegol in Adults With ALL
