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

Mayo Clinic

Status: Enrolling

Conditions: Childhood Lymphoblastic Lymphoma; Childhood Acute Lymphoblastic Leukemia

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT07071051

NCI-2025-04657 (Registry Identifier)

24-012104 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 2 to 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

Observational

Description:

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

Treatment:

Other: Non-Interventional Study