Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381004
Status:
COMPLETED
Last Update Posted:
2016-01-14
First Post:
2006-09-25
Brief Title:
FCR Plus Sargramostim GM-CSF as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Fludarabine Cyclophosphamide and Rituximab FCR Plus Sargramostim GM-CSF as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2015-12
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 using a combination of fludarabine cyclophosphamide and rituximab with sargramostim GM-CSF can help to control previously untreated chronic lymphocytic leukemia CLL The safety of this combination will also be studied This study will evaluate antibody-dependent cellular cytotoxicity ADCC and its relationship to response
Detailed Description:
Fludarabine and cyclophosphamide are designed to enter CLL cells and destroy the machinery that allows CLL cells to multiply Rituximab is designed to bind to CLL cells and cause cell death GM-CSF is designed to help the bone marrow to produce white cells It may also increase the target molecule called cluster of differentiation antigen 20 CD20 for rituximab on the surface of the CLL cells which may improve the activity of rituximab
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study You will have a complete physical exam Blood about 2 tablespoons will be drawn for routine tests The routine blood draw will include a test for hepatitis B unless this has been done within the last 6 months This routine blood draw will also include a pregnancy test for women who are able to have children To be eligible to take part in this study the pregnancy test must be negative A bone marrow aspirate and biopsy will be collected To collect a bone marrow aspirate and biopsy an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle
If you are found to be eligible to take part in the study you will receive GM-CSF thorough a needle under your skin on Day 1 Each study cycle is about 4 weeks but may be longer depending on side effects or leukemia response
You will receive rituximab through a needle in your vein on Day 2 The first infusion may take up to 8 hours For every dose of rituximab after that the infusion may take 2-4 hours The length of the infusion time depends on whether you have any reactions to the infusion The dose level of rituximab may be increased for Cycles 2-6 as well The drugs Tylenol acetaminophen and Benadryl diphenhydramine hydrochloride will be given before each dose of rituximab This will be done to decrease the risk of side effects If side effects do occur during rituximab treatment the drug may have to be stopped until the side effects go away and then restarted so your time in the outpatient area may be longer if that occurs
On Days 3-5 of the first treatment cycle fludarabine and cyclophosphamide will be given through a needle in your vein Each infusion will take about 30 minutes After the first treatment cycle fludarabine and cyclophosphamide will be given on Days 2 3 and 4 for every cycle after that
During each cycle the day after you receive fludarabine and cyclophosphamide you will begin to receive GM-CSF You will receive the drug for 1 week or until your white cell count has returned to an acceptable level
Cycle 1 will be given at MD Andersons outpatient clinic In some cases Cycle 1 may be given in the inpatient area The other 5 cycles can be given either at MD Anderson or at another location
With the exception of rituximab the same doses of all other drugs will be used throughout the study unless side effects become severe In that case the dose may be lowered or the treatment may be stopped
During each cycle blood about 1 tablespoon will be drawn once every 1-2 weeks for routine tests
You will have a bone marrow biopsy performed at the end of Cycles 3 and 6 to check the status of the disease
You may remain on study for up to 6 cycles You will be taken off study if the disease gets worse or if intolerable side effects occur
Once you are off study blood about 2 teaspoons will be drawn every 6-12 months for routine tests
This is an investigational study Fludarabine cyclophosphamide rituximab and GM-CSF are all FDA approved and commercially available However their use in this study and in this combination is considered investigational Up to 60 patients will take part in the study All will be enrolled at MD Anderson
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study You will have a complete physical exam Blood about 2 tablespoons will be drawn for routine tests The routine blood draw will include a test for hepatitis B unless this has been done within the last 6 months This routine blood draw will also include a pregnancy test for women who are able to have children To be eligible to take part in this study the pregnancy test must be negative A bone marrow aspirate and biopsy will be collected To collect a bone marrow aspirate and biopsy an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle
If you are found to be eligible to take part in the study you will receive GM-CSF thorough a needle under your skin on Day 1 Each study cycle is about 4 weeks but may be longer depending on side effects or leukemia response
You will receive rituximab through a needle in your vein on Day 2 The first infusion may take up to 8 hours For every dose of rituximab after that the infusion may take 2-4 hours The length of the infusion time depends on whether you have any reactions to the infusion The dose level of rituximab may be increased for Cycles 2-6 as well The drugs Tylenol acetaminophen and Benadryl diphenhydramine hydrochloride will be given before each dose of rituximab This will be done to decrease the risk of side effects If side effects do occur during rituximab treatment the drug may have to be stopped until the side effects go away and then restarted so your time in the outpatient area may be longer if that occurs
On Days 3-5 of the first treatment cycle fludarabine and cyclophosphamide will be given through a needle in your vein Each infusion will take about 30 minutes After the first treatment cycle fludarabine and cyclophosphamide will be given on Days 2 3 and 4 for every cycle after that
During each cycle the day after you receive fludarabine and cyclophosphamide you will begin to receive GM-CSF You will receive the drug for 1 week or until your white cell count has returned to an acceptable level
Cycle 1 will be given at MD Andersons outpatient clinic In some cases Cycle 1 may be given in the inpatient area The other 5 cycles can be given either at MD Anderson or at another location
With the exception of rituximab the same doses of all other drugs will be used throughout the study unless side effects become severe In that case the dose may be lowered or the treatment may be stopped
During each cycle blood about 1 tablespoon will be drawn once every 1-2 weeks for routine tests
You will have a bone marrow biopsy performed at the end of Cycles 3 and 6 to check the status of the disease
You may remain on study for up to 6 cycles You will be taken off study if the disease gets worse or if intolerable side effects occur
Once you are off study blood about 2 teaspoons will be drawn every 6-12 months for routine tests
This is an investigational study Fludarabine cyclophosphamide rituximab and GM-CSF are all FDA approved and commercially available However their use in this study and in this combination is considered investigational Up to 60 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