Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Lymphoblastic Leukemia (ALL) Patients: Pilot Study
NCT ID: NCT07071051
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
15 participants
OBSERVATIONAL
2025-07-31
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Observational
Patients undergo collection of blood samples and have their medical records reviewed on study.
Non-Interventional Study
Non-interventional study
Interventions
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Non-Interventional Study
Non-interventional study
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of acute lymphoblastic leukemia/lymphoma
* Planned treatment with Cal-PEG
* Informed consent obtained from parents or guardians
Exclusion Criteria
* 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
2 Years
22 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Madeleine B. O'Keefe, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2025-04657
Identifier Type: REGISTRY
Identifier Source: secondary_id
24-012104
Identifier Type: OTHER
Identifier Source: secondary_id
24-012104
Identifier Type: -
Identifier Source: org_study_id
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