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

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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