Observational Study of Calaspargase Pegol in Pediatric ALL
This observational study is looking at how a medicine called calaspargase pegol (Cal-PEG) affects the blood clotting system in children and young adults (ages 2 to 22) with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. Researchers want to see if Cal-PEG causes changes in how your blood clots and if it leads to any serious bleeding or clotting problems. You can join if you have ALL or lymphoblastic lymphoma, are planning to receive Cal-PEG, and don't have certain pre-existing conditions like clotting disorders. The study will follow about 15 participants and collect information from blood samples and medical records over approximately 12 weeks.
- Study design
- This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include about 15 participants.
- What's involved
- You would have blood samples collected and your medical records reviewed. This will happen at baseline, and then approximately 4, 11, 18, and 39 days after receiving Cal-PEG.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track any clinically relevant bleeding or clotting problems for up to 12 weeks.
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Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Lymphoblastic Leukemia (ALL) Patients: Pilot Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Madeleine B. O'Keefe, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in coagulation - frequencyBaseline (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).
- Change in coagulation - durationBaseline (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).
- Incidence of clinically relevant hematologic or thrombotic adverse eventsUp 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.