Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208975
Status:
TERMINATED
Last Update Posted:
2012-06-28
First Post:
2005-09-13
Brief Title:
Phase II Study of Fludarabine and Mitoxantrone Followed by GM-CSFGranulocyte-macrophage Colony-stimulating Factor and Rituximab
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Phase II Study of Fludarabine and Mitoxantrone Followed by GM-CSFGranulocyte-macrophage Colony-stimulating Factor and Rituximab in Patients With Low Grade Non-Hodgkins Lymphoma An Analysis of Efficacy and Tolerability
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with a low-grade or indolent slow-growing form of non-Hodgkins lymphoma NHL in which the usual survival is between 7-10 years are being asked to take part in this study Although normally-used combinations of chemotherapy will cause NHL to disappear in 30-40 of patients called complete response or complete remission almost all will have their disease return
In this study researchers tested a combination of anti-cancer agents fludarabine rituximab and GM-CSF with mitoxantrone or cyclophosphamide to see if a better and more long-lasting response can be achieved All of the medications are approved by the Food and Drug Administration FDA and are available on the market The agents we will use are
Mitoxantrone and fludarabine and cyclophosphamide and fludarabine are combinations of chemotherapy drugs that have been successfully used to treat NHLCLL Chronic lymphocytic leukemia that has returned after treatment and are comparable options for treatment
Rituximab a monoclonal antibody that kills cancer cells by binding the CD20 antigen found on the surface of B-cells commonly used along with chemotherapy drugs to improve response rates in lymphoma treatment
GM-CSF granulocyte-macrophage colony stimulating factor also called sargramostim GM or Leukine a growth factor which stimulates the development of new stem cells GM-CSF encourages stem cells to divide specialize and become active It is not a normal part of treatment for NHL
Using GM-CSF in NHL treatment is the experimental part of this study The main purpose of this study is to see if giving GM-CSF along with a standard anti-cancer treatment will work better to reduce cancer and to look at side effects of the treatment
In this study researchers tested a combination of anti-cancer agents fludarabine rituximab and GM-CSF with mitoxantrone or cyclophosphamide to see if a better and more long-lasting response can be achieved All of the medications are approved by the Food and Drug Administration FDA and are available on the market The agents we will use are
Mitoxantrone and fludarabine and cyclophosphamide and fludarabine are combinations of chemotherapy drugs that have been successfully used to treat NHLCLL Chronic lymphocytic leukemia that has returned after treatment and are comparable options for treatment
Rituximab a monoclonal antibody that kills cancer cells by binding the CD20 antigen found on the surface of B-cells commonly used along with chemotherapy drugs to improve response rates in lymphoma treatment
GM-CSF granulocyte-macrophage colony stimulating factor also called sargramostim GM or Leukine a growth factor which stimulates the development of new stem cells GM-CSF encourages stem cells to divide specialize and become active It is not a normal part of treatment for NHL
Using GM-CSF in NHL treatment is the experimental part of this study The main purpose of this study is to see if giving GM-CSF along with a standard anti-cancer treatment will work better to reduce cancer and to look at side effects of the treatment
Detailed Description:
Patients with a low-grade or indolent slow-growing form of non-Hodgkins lymphoma NHL in which the usual survival is between 7-10 years are being asked to take part in this study Although normally-used combinations of chemotherapy will cause NHL to disappear in 30-40 of patients called complete response or complete remission almost all will have their disease return
When NHL is diagnosed an abundance of white blood cells called B-lymphocytes or B-cells are found in the body Almost all B-cells have a special protein on the surface called a CD20 antigen Some anti-cancer drugs called monoclonal antibodies target cancer cells by binding or locking up specific antigens found on their surfaces which kills the cancer cells
In this study researchers will test a combination of anti-cancer agents to see if a better and more long-lasting response can be achieved All of the medications are approved by the Food and Drug Administration FDA and are available on the market The agents we will use are
-Mitoxantrone and fludarabine a combination of chemotherapy drugs that has been successfully used to treat NHL that has returned after treatment
OR
Cyclophosphamide and fludarabine a combination of chemotherapy drugs that has been successfully used to treat NHL that has returned after treatment
Rituximab a monoclonal antibody that kills cancer cells by binding the CD20 antigen found on the surface of B-cells commonly used along with chemotherapy drugs to improve response rates in lymphoma treatment
GM-CSF granulocyte-macrophage colony stimulating factor also called sargramostim GM or Leukine a growth factor which stimulates the development of new stem cells GM-CSF encourages stem cells to divide specialize and become active It is not a normal part of treatment for NHL
Using GM-CSF in NHL treatment is the experimental part of this study In studies done in the laboratory GM-CSF caused an increase in the number of antigens such as CD20 on the surface of B-cells If more antigens are present it may be easier to target cells that express CD20 or other antigens Monoclonal antibodies such as rituximab might then be able to more effectively bind the antigens and kill the cancer cells
The main purpose of this study is to see if giving GM-CSF along with a standard anti-cancer treatment will work better to reduce cancer and to look at side effects of the treatment
When NHL is diagnosed an abundance of white blood cells called B-lymphocytes or B-cells are found in the body Almost all B-cells have a special protein on the surface called a CD20 antigen Some anti-cancer drugs called monoclonal antibodies target cancer cells by binding or locking up specific antigens found on their surfaces which kills the cancer cells
In this study researchers will test a combination of anti-cancer agents to see if a better and more long-lasting response can be achieved All of the medications are approved by the Food and Drug Administration FDA and are available on the market The agents we will use are
-Mitoxantrone and fludarabine a combination of chemotherapy drugs that has been successfully used to treat NHL that has returned after treatment
OR
Cyclophosphamide and fludarabine a combination of chemotherapy drugs that has been successfully used to treat NHL that has returned after treatment
Rituximab a monoclonal antibody that kills cancer cells by binding the CD20 antigen found on the surface of B-cells commonly used along with chemotherapy drugs to improve response rates in lymphoma treatment
GM-CSF granulocyte-macrophage colony stimulating factor also called sargramostim GM or Leukine a growth factor which stimulates the development of new stem cells GM-CSF encourages stem cells to divide specialize and become active It is not a normal part of treatment for NHL
Using GM-CSF in NHL treatment is the experimental part of this study In studies done in the laboratory GM-CSF caused an increase in the number of antigens such as CD20 on the surface of B-cells If more antigens are present it may be easier to target cells that express CD20 or other antigens Monoclonal antibodies such as rituximab might then be able to more effectively bind the antigens and kill the cancer cells
The main purpose of this study is to see if giving GM-CSF along with a standard anti-cancer treatment will work better to reduce cancer and to look at side effects of the treatment
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