This study evaluates the impact of calaspargase pegol (Cal-PEG) on the coagulation system in pediatric patients with acute lymphoblastic leukemia/lymphoma (ALL).
Age 2-21.5 years
Confirmed diagnosis of acute lymphoblastic leukemia/lymphoma
Planned treatment with Cal-PEG
Informed consent obtained from parents or guardians
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)
Participants will be pediatric patients diagnosed with ALL and scheduled to receive Cal-PEG as part of their treatment regimen.
Case-control
Prospective
Non-Interventional Study
Other interventionNon-interventional study
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).
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).
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.
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