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Recruiting NCT07071051

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

— Observational Childhood Acute Lymphoblastic Leukemia Childhood Lymphoblastic Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Childhood Acute Lymphoblastic Leukemia, Childhood Lymphoblastic Lymphoma. Basic parameters: 2 years — 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • 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]
  • Change in coagulation - duration [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]
  • Incidence of clinically relevant hematologic or thrombotic adverse events [Time frame: Up to 12 weeks]

Eligibility criteria

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
  • Use of systemic blood thinner within 48 hours prior to study blood draw

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07071051 · 24-012104 · NCI-2025-04657 · 24-012104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗