Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448019
Status:
COMPLETED
Last Update Posted:
2015-11-01
First Post:
2007-03-13
Brief Title:
FCR and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia CLL
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Fludarabine Cyclophosphamide Rituximab and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2015-10
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 goal of this clinical research study is to learn if the combination of fludarabine cyclophosphamide rituximab and bevacizumab is effective in treating chronic lymphocytic leukemia in patients who have already been treated with chemotherapy The safety of this treatment will also be studied
Detailed Description:
During the study you will have up to 6 cycles of treatment A cycle is made up of treatment with the study drugs for 3-4 days and then about 3-12 weeks 25 days of no treatment about 4 weeks total Treatment with the study drugs will be given for 4 days in a row on the first cycle and 3 days in a row on Cycles 2-6 On Day 1 of each cycle you will receive rituximab through a needle in a vein On Cycle 1 since it is your first exposure to rituximab it must be given slowly so it may take 6-8 hours to complete On the cycles after that it can be given more rapidly over 3-4 hours Cyclophosphamide and fludarabine will be given separately through a needle in a vein on Days 2-4 of Cycle 1 and Days 1-3 of Cycles 2-6 Cyclophosphamide and fludarabine will each be given over 30 minutes Bevacizumab will be given through a needle in a vein over 90 minutes on Day 3 of Cycle 1 If it is well tolerated the next dose of Bevacizumab will be given over 60 minutes on Day 2 of Cycle 2 If the Cycle 2 dose is well tolerated the next doses of Bevacizumab will be given over 30 minutes on Day 2 of Cycles 2-6 In addition to the study drugs you may also be given fluids by vein to help flush the kidneys to help prevent possible kidney damage You may receive up to 6 cycles of treatment Treatment will be given on an outpatient basis The injections for each daily treatment visit should take less than 6 hours
Up to 66 patients will take part in the study All will be enrolled at MD Anderson
Up to 66 patients will take part in the study All will be enrolled at MD Anderson
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 |
|---|---|---|---|
| NCI-2010-00591 | REGISTRY | NCI CTRP | None |