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

Mayo Clinic15 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Childhood Acute Lymphoblastic Leukemia Childhood Lymphoblastic Lymphoma

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Eligibility

Sex: ALLMin age: 2 YearsMax age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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).

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

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).

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

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.

Time frame: Up to 12 weeks

Central Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015 mayocliniccancerstudies@mayo.edu

Data from ClinicalTrials.gov

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