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

Not yet recruiting

• Conditions: Childhood Acute Lymphoblastic Leukemia; Childhood Lymphoblastic Lymphoma

• Registration Number: NCT07071051
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-16
• Last Update Submitted: 2025-07-16
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17
• Study Start: 2025-08-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in coagulation - frequency	Baseline (either before first dose or after at least 6 weeks from last Cal-PEG administration); approximately 4, 11, 18, and 39 days after Cal-PEG administration	Frequency of coagulation changes in patients with Acute Lymphoblastic Leukemia (ALL) who receive Cal-peg as part of their treatment. Blood samples will be collected at baseline (pre-treatment: either before first dose or after at least 6 weeks from last Cal-PEG administration) and at 4-, 11-, 18-, and 39-- -days post-Cal-PEG administration (time points can be adjusted based on routine clinical testing within ± 4 days).
Change in coagulation - duration	Baseline (either before first dose or after at least 6 weeks from last Cal-PEG administration); approximately 4, 11, 18, and 39 days after Cal-PEG administration	Duration of coagulation changes in patients with Acute Lymphoblastic Leukemia (ALL) who receive Cal-peg as part of their treatment. Blood samples will be collected at baseline (pre-treatment: either before first dose or after at least 6 weeks from last Cal-PEG administration) and at 4-, 11-, 18-, and 39-- -days post-Cal-PEG administration (time points can be adjusted based on routine clinical testing within ± 4 days).
Incidence of clinically relevant hematologic or thrombotic adverse events	Up to 12 weeks	Assessed according to Common Terminology Criteria for Adverse Events (CTCAE) criteria. Will describe clinically relevant hematologic or thrombotic adverse events in patients with ALL who receive Cal-PEG as part of their treatment.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States