Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230282
Status:
COMPLETED
Last Update Posted:
2014-10-06
First Post:
2005-09-28
Brief Title:
Phase 2 Fludarabine Cytoxan and FCCAM Alemtuzumab in Untreated B-Cell Chronic Lymphocytic Leukemia
Sponsor:
Steven E Coutre
Organization:
Stanford University
Study Overview
Official Title:
A Multi-Center Phase 2 Efficacy and Pharmacokinetic Study Evaluating Fludarabine Cyclophosphamide and Subcutaneous Campath FCCam Alemtuzumab for Previously Untreated B-Cell Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2014-09
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:
The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients Participants will receive fludarabine and cyclophosphamide on days 1 2 and 3 of six 28-day cycles
Detailed Description:
This single-arm study evaluated the safety and efficacy of the combination of fludarabine 25 mgm2d IV and cyclophosphamide 250 mgm2d SC in previously untreated CLL patients Participants received fludarabine and cyclophosphamide on days 1 2 and 3 of six 28-day cycles followed by a no-treatment rest period observation for 3 to 12 weeks
Responders entered a no-treatment rest period observation for 3 to 8 weeks then depending on status continued on follow-up or on-study to receive Campath stating at 3 mgday with the dose adjusted to the maximum tolerated dose
Responders entered a no-treatment rest period observation for 3 to 8 weeks then depending on status continued on follow-up or on-study to receive Campath stating at 3 mgday with the dose adjusted to the maximum tolerated dose
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 |
|---|---|---|---|
| HEMCLL0001 | OTHER | OnCore | None |
| 31185 | OTHER | None | None |
| 80071 | OTHER | None | None |