Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230178
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2005-09-28
Brief Title:
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Evaluation of Single Agent Rasburicase for 5 Days Versus Sequential Treatment With Rasburicase From Day 1 Through 3 Followed by Oral Allopurinol From Day 3 Through 5 Overlap on Day 3 Versus Single Agent Oral Allopurinol for 5 Days in the Management of Plasma Uric Acid in Adult Patients With Leukemia Lymphoma and Solid Tumor Malignancies at Risk for Hyperuricemia and Tumor Lysis Syndrome
Status:
COMPLETED
Status Verified Date:
2010-01
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 a randomized multi-center open-label parallel group study with three arms
Rasburicase alone
Rasburicase followed by Allopurinol
Allopurinol alone
The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms
Rasburicase alone
Rasburicase followed by Allopurinol
Allopurinol alone
The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms
Detailed Description:
After signing the informed consent and having met the inclusion criteria patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol
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