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NCT Number: NCT07071051

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

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

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Key information

Conditions

Childhood Acute Lymphoblastic Leukemia Childhood Lymphoblastic Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

2 year–22 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials

CONTACT

[email protected]

Madeleine B. O'Keefe, MD

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVES:

I. Evaluate the impact of Calaspargase Pegol (Cal-PEG) on the coagulation system in pediatric ALL patients.

II. Compare bleeding and thrombotic events associated with Cal-PEG to historical controls treated with pegaspargase.

OUTLINE: This is an observational study.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Change in coagulation - frequency

    Time frame: 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

    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).

  2. Change in coagulation - duration

    Time frame: 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

    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).

  3. Incidence of clinically relevant hematologic or thrombotic adverse events

    Time frame: Up to 12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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