Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206726
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2005-09-19
Brief Title:
AlemtuzumabFludarabine for RelapsedRefractory B-cell Chronic Lymphocytic Leukemia B-CLL
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Phase II Study Using Alemtuzumab Combined With Fludarabine for the Treatment of RelapsedRefractory B-cell Chronic Lymphocytic Leukemia B-CLL
Status:
COMPLETED
Status Verified Date:
2016-07
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:
ECO-1
Brief Summary:
This is a multi-center Phase II open label trial evaluating the efficacy and safety of alemtuzumab and fludarabine in the treatment of B-cell chronic lymphocytic leukemia B-CLL patients who have received at least one prior therapy
Treatments will be administered on a 28-day cycle for 4-6 cycles with an evaluation during Cycle 4 to permit re-staging Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6 At the time of the re-staging patients achieving a Partial Remission PR or Stable Disease SD will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission CR will receive no further treatment but will be followed for response
Treatments will be administered on a 28-day cycle for 4-6 cycles with an evaluation during Cycle 4 to permit re-staging Alemtuzumab and fludarabine will be administered on Days 1-5 of each cycle Patients will be assessed for response at the time of re-staging at Cycle 4 and at the end of Cycle 6 At the time of the re-staging patients achieving a Partial Remission PR or Stable Disease SD will be given an additional 2 cycles of treatment and patients demonstrating presumptive signs of a Complete Remission CR will receive no further treatment but will be followed for response
Detailed Description:
As of April 2011 Bayer transferred this record to Genzyme Genzyme is now the sponsor of this trial NOTE This study has previously been posted by Berlex Inc Berlex Inc has been renamed to Bayer HealthCare Pharmaceuticals Inc
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 305825 | OTHER | Sanofi | None |