Calaspargase pegol and blood clotting in children with ALL or lymphoblastic lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.