NCT07071051

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 2 Years – 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Childhood Acute Lymphoblastic Leukemia
• Childhood Lymphoblastic Lymphoma

Interventions

Type	Name	Description
OTHER	Non-Interventional Study	Non-interventional study

Timeline

• Start date: 2025-07-31
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-07-17
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States