Calaspargase pegol and blood clotting in children with ALL or lymphoblastic lymphoma
Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Lymphoblastic Leukemia (ALL) Patients: Pilot Study
This will see if calaspargase pegol changes blood clotting or the risk of bleeding and clots in children and young adults treated for acute lymphoblastic leukemia or lymphoblastic lymphoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 2 Years to 22 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT07071051 on ClinicalTrials.gov |
What this trial studies
This observational pilot enrolls pediatric patients aged 2 to 21.5 with confirmed acute lymphoblastic leukemia or lymphoblastic lymphoma who are planned to receive calaspargase pegol. Investigators collect blood samples at specified times and review medical records to measure coagulation markers and record bleeding or thrombotic events. Findings from participants will be compared to historical controls treated with pegaspargase to identify differences in coagulation effects. The study excludes patients with conditions or treatments that independently affect coagulation testing, such as pre-existing clotting disorders, liver failure, nephrotic syndrome, recent anticoagulant use, or pregnancy.
Who should consider this trial
Good fit: Children and young adults aged 2 to 21.5 with confirmed ALL or lymphoblastic lymphoma who are scheduled to receive calaspargase pegol and whose parent/guardian can provide consent.
Not a fit: Patients with pre-existing coagulation disorders, liver failure, conditions that affect coagulation testing, current pregnancy, or recent use of systemic blood thinners are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, the results could help doctors better predict and manage bleeding and clotting risks in children receiving calaspargase pegol.
How similar studies have performed: Previous studies of asparaginase products like pegaspargase have documented effects on clotting and bleeding, but direct data specifically comparing calaspargase pegol's coagulation effects are limited, making this pilot relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Madeleine B. O'Keefe, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.