Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration

Not yet recruiting

• Conditions: Childhood Acute Lymphoblastic Leukemia; Childhood Lymphoblastic Lymphoma

• Registration Number: NCT07221656
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-24
• Study First Submitted QC: 2025-10-24
• Study First Posted: 2025-10-28
• Last Update Submitted: 2025-10-29
• Last Update Posted: 2025-10-31
• Study Start: 2025-11-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of therapeutic SAA	Up to 15 months	Descriptive statistics including medians and interquartile ranges will be utilized to summarize continuous variables.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States