Calaspargase Pegol On The Coagulation System In Pediatric Acute Lymphoblastic Leukemia (ALL) Patients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 24-012104
NCT ID: NCT07071051
Sponsor Protocol Number: 24-012104
About this study
The purpose of this study is to evaluate the impact of Calaspargase Pegol (Cal-PEG) on the coagulation system in Pediatric Acute Lymphoblastic Leukemia (ALL) patients.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Age 0-21.5 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)
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 11/07/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Madeleine O'Keefe, M.D. |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available