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NCT Number: NCT07221656

Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration

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.

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Key information

Conditions

Childhood Acute Lymphoblastic Leukemia Childhood Lymphoblastic Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Madeleine B. O'Keefe, MD

PRINCIPAL_INVESTIGATOR

Pediatric Research

CONTACT

507-266-2942

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

  1. Duration of therapeutic SAA

    Time frame: Up to 15 months

    Descriptive statistics including medians and interquartile ranges will be utilized to summarize continuous variables.

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Oct 28, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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