Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration

Mayo Clinic

Status: Not yet enrolling

Conditions: Childhood Lymphoblastic Lymphoma; Childhood Acute Lymphoblastic Leukemia

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT07221656

NCI-2025-07667 (Registry Identifier)

25-009034 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Observational

Description:

Patients provide blood samples collected during regularly scheduled appointments and have medical records reviewed throughout the study.

Treatment:

Other: Non-Interventional Study