Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration

NCT ID: NCT07221656

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Childhood Acute Lymphoblastic Leukemia Childhood Lymphoblastic Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

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

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Other Intervention Names

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Non-Interventional Observational Study Noninterventional (Observational) Study

Eligibility Criteria

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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
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Madeleine B. O'Keefe, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

855-776-0015

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Pediatric Research

Role: backup

507-266-2942

Related Links

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Other Identifiers

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NCI-2025-07667

Identifier Type: REGISTRY

Identifier Source: secondary_id

25-009034

Identifier Type: OTHER

Identifier Source: secondary_id

25-009034

Identifier Type: -

Identifier Source: org_study_id

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