Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046683
Status:
COMPLETED
Last Update Posted:
2016-07-28
First Post:
2002-10-01
Brief Title:
EfficacySafety of Frontline Alemtuzumab Campath MabCampath vs Chlorambucil in Patients With Progressive B-Cell Lymphocytic Leukemia
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase III Study to Evaluate the Efficacy and Safety of Front-Line Therapy With Alemtuzumab Campath MabCampath vs Chlorambucil in Patients With Progressive B-Cell Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase III open-label multicenter randomized comparative study of Campath versus chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia B-CLL Eligible patients must have previously untreated Rai stage I-IV disease and be experiencing progression of their B-CLL requiring treatment Patients who meet all eligibility criteria may be randomized on a 11 basis to receive either Campath or chlorambucil An estimated 284 patients 142 per treatment arm from approximately 40 or more investigational sites will be randomized to one of the two treatment arms
Detailed Description:
None
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