NCT07071051Recruiting

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

Mayo Clinic

Start Date

7/31/2025

Completion Date

12/31/2026

Summary

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

Detailed 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.

Eligibility Criteria

Age Range: 2 years to 22 years

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

Interventions

OTHER

Non-Interventional Study

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Conditions

Childhood Acute Lymphoblastic LeukemiaChildhood Lymphoblastic Lymphoma

Locations

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States