Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration
2 other identifiers
observational
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2027
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2025
CompletedFirst Posted
Study publicly available on registry
October 28, 2025
CompletedStudy Start
First participant enrolled
February 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
Study Completion
Last participant's last visit for all outcomes
December 31, 2028
April 2, 2026
March 1, 2026
1.9 years
October 24, 2025
March 31, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of therapeutic SAA
Descriptive statistics including medians and interquartile ranges will be utilized to summarize continuous variables.
Up to 15 months
Other Outcomes (2)
Asparaginase-related toxicities correlated with duration of therapeutic SAA levels
Up to 15 months
Asparaginase-related toxicities correlated with peak SAA levels
Up to 15 months
Study Arms (1)
Observational
Patients provide blood samples collected during regularly scheduled appointments and have medical records reviewed throughout the study.
Interventions
Non-interventional study
Eligibility Criteria
Patients with acute lymphoblastic leukemia/lymphoma being treated by the pediatric hematology team at Mayo Clinic in Rochester
You may qualify if:
- Acute lymphoblastic leukemia/lymphoma being treated by the pediatric hematology team
- Receiving calaspargase as part of treatment for malignancy
You may not qualify if:
- Age \> 21 years
- Patients who are actively enrolled on Children's Oncology Group (COG) trial AALL1732 in an inotuzumab containing arm
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Madeleine B. O'Keefe, MD
Mayo Clinic in Rochester
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2025
First Posted
October 28, 2025
Study Start (Estimated)
February 1, 2027
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share