Non Hodgkin Lymphoma Clinical Trial
A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin’s Lymphoma
Summary
The purpose of this study is to assess the feasibility, efficacy and safety of adding bevacizumab to rituximab compared to rituximab alone in patients with previously treated follicular non-hodgkin's lymphoma (NHL) whose disease has progressed following at least one previous chemotherapy regimen and not more than 2 previous chemotherapy regimens.
Full Description
Upon determination of eligibility, patients will randomly be assigned to one of two treatment arms:
Rituximab
Rituximab + bevacizumab
For every 2 patients randomized, 1 will receive treatment number 1 (rituximab), and 1 patient will receive treatment number 2 (rituximab + bevacizumab). This is not a blinded study, so both the patient and doctor will know which treatment has been assigned.
Eligibility Criteria
Inclusion Criteria:
To be included in the study, you must meet the following criteria:
Follicular NHL, grades 1 or 2 confirmed by a biopsy sample
18 years of age or older
Evidence of disease progression at time of study entry
Must have had at least one previous chemotherapy regimen and not more than two previous chemotherapy regimens.
Patients who have received previous rituximab are eligible as long as progression occurred more than six months following completion of previous rituximab therapy.
Measurable or evaluable disease
Able to perform activities of daily living without considerable assistance
Adequate bone marrow, kidney, and liver function
Signed informed consent obtained prior to initiation of any study-specific procedures or treatment.
Exclusion Criteria:
You cannot participate in the study if any of the following apply to you:
Treatment with more than two previous chemotherapy regimens
Prior treatment with bevacizumab or other similar agents
Progressive NHL less than 6 months after receiving previous rituximab
More than 1 prior treatment with investigational agents within 4 weeks prior to entering this study
Spread of NHL to brain or nervous system
History of any other uncontrolled or significant disease or medical condition that may put them at high risk for treatment complications with these agents
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
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There are 20 Locations for this study
Jonesboro Arkansas, 72401, United States
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32256, United States
Lakeland Florida, 33805, United States
Orlando Florida, 32804, United States
Augusta Georgia, 30901, United States
Gainesville Georgia, 30501, United States
Marietta Georgia, 30060, United States
Terre Haute Indiana, 47802, United States
Bowling Green Kentucky, 42101, United States
Louisville Kentucky, 40207, United States
Louisville Kentucky, 40207, United States
Baton Rouge Louisiana, 70809, United States
Bethesda Maryland, 20817, United States
Bethesda Maryland, 20817, United States
Omaha Nebraska, 68114, United States
Morristown New Jersey, 07960, United States
Cincinnati Ohio, 45242, United States
West Reading Pennsylvania, 19611, United States
Spartanburg South Carolina, 29303, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37023, United States
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