SPARK-ALL: Calaspargase Pegol in Adults with ALL

Servier

Status and phase

Active, not recruiting

Phase 3

Phase 2

Conditions

Acute Lymphoblastic Leukemia

Treatments

Drug: Calaspargase pegol (S95015)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04817761

CL2-95015-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

122 estimated patients

Sex

All

Ages

22 to 55 years old

Volunteers

No Healthy Volunteers

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.