Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration

March 31, 2026 updated by: Mayo Clinic
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Madeleine B. O'Keefe, MD
        • Contact:
          • Pediatric Research
          • Phone Number: 507-266-2942

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute lymphoblastic leukemia/lymphoma being treated by the pediatric hematology team at Mayo Clinic in Rochester

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients provide blood samples collected during regularly scheduled appointments and have medical records reviewed throughout the study.
Other: Non-Interventional Study
Non-interventional study
Other Names:
  • Non-Interventional Observational Study
  • Noninterventional (Observational) Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of therapeutic SAA
Time Frame: Up to 15 months
Descriptive statistics including medians and interquartile ranges will be utilized to summarize continuous variables.
Up to 15 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asparaginase-related toxicities correlated with duration of therapeutic SAA levels
Time Frame: Up to 15 months
Spline plots will be used to assess any correlation between duration of therapeutic SAA levels and incidence of asparaginase-associated toxicities. Categorical data including toxicity information will be summarized descriptively. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, per standard of care.
Up to 15 months
Asparaginase-related toxicities correlated with peak SAA levels
Time Frame: Up to 15 months
Spline plots will be used to assess any correlation between peak SAA levels and incidence of asparaginase-associated toxicities. Categorical data including toxicity information will be summarized descriptively. Toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, per standard of care.
Up to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Madeleine B. O'Keefe, MD, Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

October 24, 2025

First Submitted That Met QC Criteria

October 24, 2025

First Posted (Actual)

October 28, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-009034 (Other Identifier: Mayo Clinic)
  • NCI-2025-07667 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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