Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280241
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2006-01-19
Brief Title:
Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase II Clinical Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2016-01
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 research study will look at the effects good or bad of administering cyclophosphamide fludarabine and rituximab Clinical studies with combination therapy have shown higher response rates than using single drugs and this study will evaluate the side effects and effectiveness of this combination
Detailed Description:
This study is designed to expand on the highly successful combination of rituximab fludarabine and cyclophosphamide for patients with previously untreated CLL Responses in the range of 90-98 with 55 complete responses are reported However bone marrow toxicity has been a significant problem This trial is designed to reduce the bone marrow toxicity by decreasing the doses of fludarabine and cyclophosphamide but doubling the dose of rituximab with a maintenance dose of rituximab for up to two years to maintain or even enhance efficacy
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