Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Ly
This study evaluates the impact of calaspargase pegol (Cal-PEG) on the coagulation system in pediatric patients with acute lymphoblastic leukemia/lymphoma (ALL).
| Condition(s) | Childhood Acute Lymphoblastic Leukemia, Childhood Lymphoblastic Lymphoma |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This study evaluates the impact of calaspargase pegol (Cal-PEG) on the coagulation system in pediatric patients with acute lymphoblastic leukemia/lymphoma (ALL). |
| Who can participate | 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 |
| Ages | 2 Years to 22 Years |
| Sex | All |
| Lead sponsor | Mayo Clinic |
| Locations | Rochester, Minnesota, United States |
| Start date | 2025-07-31 |
| NCT ID | NCT07071051 |
| Official listing | https://clinicaltrials.gov/study/NCT07071051 |