Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-31 @ 2:50 PM
Study NCT ID:
NCT07071051
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Lymphoblastic Leukemia (ALL) Patients: Pilot Study
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Exploring the Effect of Calaspargase Pegol on the Coagulation System in Pediatric Acute Lymphoblastic Leukemia (ALL) Patients: Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates the impact of calaspargase pegol (Cal-PEG) on the coagulation system in pediatric patients with acute lymphoblastic leukemia/lymphoma (ALL).
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: