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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07071051
Status
Recruiting
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Conditions

  • Childhood Acute Lymphoblastic Leukemia
  • Childhood Lymphoblastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
2 Years - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • Non-Interventional Study — OTHER
    Non-interventional study

Study Details

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

Key Dates

First listed
Jul 17, 2025
Start date
Jul 31, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
15 participants (estimated)

Arms

  • Arm: Observational
    Patients undergo collection of blood samples and have their medical records reviewed on study.

Primary Outcome Measure

Change in coagulation - frequency [ Time Frame: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials
[email protected]
Madeleine B. O'Keefe, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Rochester· Rochester, MN

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