Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230217
Status:
COMPLETED
Last Update Posted:
2009-03-30
First Post:
2005-09-28
Brief Title:
Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma Leukemia or Solid Tumor Malignancy
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Evaluation of Single Agent Rasburicase in TreatmentPrevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Adult and Pediatric Patients With LymphomaLeukemiaSolid Tumor Malignancies at Their First Relapse or Refractory Disease
Status:
COMPLETED
Status Verified Date:
2009-03
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 is an open-label multi-center study with 2 arms The primary objective is to assess the response to treatment with rasburicase in 2 populations of adult and pediatric patients with lymphomaleukemiasolid tumor malignancies those previously treated with a uricolytic agent and those not previously treated with a uricolytic agent at their first relapse or refractory disease
Detailed Description:
This is a multi-center 2 arm open-label study
Arm A Patients previously treated with a uricolytic agent
Arm B Patients not previously treated with a uricolytic agent
Patients receive rasburicase for 5 days and begin chemotherapy 4-24 hours after the first dose of rasburicase Patients are followed at 14 and 35 days at 3 and 6 months and every 6 months thereafter
Arm A Patients previously treated with a uricolytic agent
Arm B Patients not previously treated with a uricolytic agent
Patients receive rasburicase for 5 days and begin chemotherapy 4-24 hours after the first dose of rasburicase Patients are followed at 14 and 35 days at 3 and 6 months and every 6 months thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None