Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Lymphoblastic Leukemia (ALL) Patients: Pilot Study
Purpose
This study evaluates the impact of calaspargase pegol (Cal-PEG) on the coagulation system in pediatric patients with acute lymphoblastic leukemia/lymphoma (ALL).
Conditions
- Childhood Acute Lymphoblastic Leukemia
- Childhood Lymphoblastic Lymphoma
Eligibility
- Eligible Ages
- Between 2 Years and 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Observational | Patients undergo collection of blood samples and have their medical records reviewed on study. |
|
Recruiting Locations
Mayo Clinic in Rochester
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
More Details
- Status
- Recruiting
- Sponsor
- Mayo Clinic
Detailed Description
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.