Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Lymphoblastic Leukemia (ALL) Patients: Pilot Study

NCT07071051 | Recruiting

• 2 other identifiers: 24-012104NCI-2025-04657
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the impact of calaspargase pegol (Cal-PEG) on the coagulation system in pediatric patients with acute lymphoblastic leukemia/lymphoma (ALL).

Conditions

Childhood Acute Lymphoblastic Leukemia; Childhood Lymphoblastic Lymphoma

Outcome Measures

Primary Outcomes (3)

• Change in coagulation - frequency

  Frequency of coagulation changes in patients with Acute Lymphoblastic Leukemia (ALL) who receive Cal-peg as part of their treatment. Blood samples will be collected at baseline (pre-treatment: either before first dose or after at least 6 weeks from last Cal-PEG administration) and at 4-, 11-, 18-, and 39-- -days post-Cal-PEG administration (time points can be adjusted based on routine clinical testing within ± 4 days).

  Baseline (either before first dose or after at least 6 weeks from last Cal-PEG administration); approximately 4, 11, 18, and 39 days after Cal-PEG administration

• Change in coagulation - duration

  Duration of coagulation changes in patients with Acute Lymphoblastic Leukemia (ALL) who receive Cal-peg as part of their treatment. Blood samples will be collected at baseline (pre-treatment: either before first dose or after at least 6 weeks from last Cal-PEG administration) and at 4-, 11-, 18-, and 39-- -days post-Cal-PEG administration (time points can be adjusted based on routine clinical testing within ± 4 days).

  Baseline (either before first dose or after at least 6 weeks from last Cal-PEG administration); approximately 4, 11, 18, and 39 days after Cal-PEG administration

• Incidence of clinically relevant hematologic or thrombotic adverse events

  Assessed according to Common Terminology Criteria for Adverse Events (CTCAE) criteria. Will describe clinically relevant hematologic or thrombotic adverse events in patients with ALL who receive Cal-PEG as part of their treatment.

  Up to 12 weeks

Study Arms (1)

Observational

Patients undergo collection of blood samples and have their medical records reviewed on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 2 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be pediatric patients diagnosed with ALL and scheduled to receive Cal-PEG as part of their treatment regimen.

You may qualify if:

• Age 2-21.5 years
• Confirmed diagnosis of acute lymphoblastic leukemia/lymphoma
• Planned treatment with Cal-PEG
• Informed consent obtained from parents or guardians

You may not qualify if:

• Pre-existing coagulation disorders
• Known hypersensitivity to asparaginase products
• Liver failure
• Any acute or chronic disease that is known to affect coagulation testing (e.g. nephrotic syndrome)
• Currently pregnant
• Use of systemic blood thinner within 48 hours prior to study blood draw

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Madeleine B. O'Keefe, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)