Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201682
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2005-09-12
Brief Title:
Etanercept and Rituximab in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Sponsor:
John Byrd
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase III Study of Etanercept and Rituximab in Patients With Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-02
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:
This is a phase III study of the combination of etanercept and rituximab in patients with chronic lymphocytic leukemia CLL and small lymphocytic lymphoma SLL This combination is proposed to improve the efficacy and diminish the toxicity of this the
Detailed Description:
Rationale Previous research has demonstrated that rituximab has efficacy against chronic lymphocytic leukemia CLL and small lymphocytic lymphoma SLL Rituximab is a monoclonal antibody used to treat different types of lymphomas Monoclonal antibodies are a type of immunotherapy used against some types of cancer They are produced in a laboratory and designed to target as well as bind with cells that carry specific proteins Rituximab attaches to a protein called CD20 that is found almost exclusively on the surface of B-cells Once rituximab attaches to the protein the immune system activates to kill the malignant B-cells Researchers are investigating what other therapies to combine with rituximab to reduce side effects and improve patient outcomes The current study combines etanercept with rituximab Etanercept is an anti-inflammatory agent being tested as a therapy for cancer Researchers want to assess the theory that etanercept may reduce the toxicity associated with rituximab in patients and increase efficacy while providing its own treatment benefit to patients
Purpose This study is evaluating the safety and efficacy of combination etanercept and rituximab in patients with CLL and SLL The biological response of tumor cells and the immune system to this drug combination will also be measured in patients before during and after therapy administration
Treatment Patients in this study will receive etanercept and rituximab Etanercept is given through injections into the skin and rituximab through intravenous infusions During the first week of the study etanercept alone will be given to patients two times During the second week patients will continue receiving etanercept twice weekly and begin receiving rituximab three times weekly This schedule of etanercept twice weekly and rituximab three times weekly will be repeated four times Several tests and exams will be given throughout the study to closely monitor patients Treatments will be discontinued due to disease growth or unacceptable side effects
Purpose This study is evaluating the safety and efficacy of combination etanercept and rituximab in patients with CLL and SLL The biological response of tumor cells and the immune system to this drug combination will also be measured in patients before during and after therapy administration
Treatment Patients in this study will receive etanercept and rituximab Etanercept is given through injections into the skin and rituximab through intravenous infusions During the first week of the study etanercept alone will be given to patients two times During the second week patients will continue receiving etanercept twice weekly and begin receiving rituximab three times weekly This schedule of etanercept twice weekly and rituximab three times weekly will be repeated four times Several tests and exams will be given throughout the study to closely monitor patients Treatments will be discontinued due to disease growth or unacceptable side effects
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