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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

Recruiting
2-22 years
All
Phase N/A
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Overview

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

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

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

Study details
    Childhood Acute Lymphoblastic Leukemia
    Childhood Lymphoblastic Lymphoma

NCT07071051

Mayo Clinic

15 October 2025

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