Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Lymphoblastic Leukemia (ALL) Patients: Pilot Study

Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Lymphoblastic Leukemia (ALL) Patients: Pilot Study

This study evaluates the impact of calaspargase pegol (Cal-PEG) on the coagulation system in pediatric patients with acute lymphoblastic leukemia/lymphoma (ALL).

PRIMARY OBJECTIVES:

I. Evaluate the impact of Calaspargase Pegol (Cal-PEG) on the coagulation system in pediatric ALL patients.

II. Compare bleeding and thrombotic events associated with Cal-PEG to historical controls treated with pegaspargase.

OUTLINE: This is an observational study.

Patients undergo collection of blood samples and have their medical records reviewed on study.

Inclusion Criteria:

• Age 2-21.5 years
• Confirmed diagnosis of acute lymphoblastic leukemia/lymphoma
• Planned treatment with Cal-PEG
• Informed consent obtained from parents or guardians

Exclusion Criteria:

• Pre-existing coagulation disorders
• Known hypersensitivity to asparaginase products
• Liver failure
• Any acute or chronic disease that is known to affect coagulation testing (e.g. nephrotic syndrome)
• Currently pregnant
• Use of systemic blood thinner within 48 hours prior to study blood draw