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Not yet recruiting NCT07221656

Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration

— 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: up to 21 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 →

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Overview

This study evaluates the median duration of therapeutic serum asparaginase activity (SAA) levels after administration of calaspargase pegol (Cal-PEG) and the potential association between peak SAA levels and duration of therapeutic levels with toxicity in pediatric patients with acute lymphoblastic leukemia or lymphoma.

Interventions

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • Duration of therapeutic SAA [Time frame: Up to 15 months]

Eligibility criteria

Inclusion criteria

  • Acute lymphoblastic leukemia/lymphoma being treated by the pediatric hematology team
  • Receiving calaspargase as part of treatment for malignancy

Exclusion criteria

  • Age > 21 years
  • Patients who are actively enrolled on Children's Oncology Group (COG) trial AALL1732 in an inotuzumab containing arm
  • Pregnancy

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
Cohort

Study locations

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

Identifiers

NCT: NCT07221656 · 25-009034 · NCI-2025-07667 · 25-009034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗