A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma
Lymphoma, Follicular
About this trial
This is an interventional treatment trial for Lymphoma, Follicular focused on measuring Lymphoma, Bevacizumab, Rituximab
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.
Sites / Locations
- Northeast Arkansas Clinic
- Florida Cancer Specialists
- Integrated Community Oncology Network
- Watson Clinic for Cancer Research
- Florida Hospital Cancer Institute
- Medical Oncology Associates of Augusta
- Northeast Georgia Medical Center
- Wellstar Cancer Research
- Providence Medical Group
- Graves-Gilbert Clinic
- Baptist Hospital East
- Norton Cancer Institute
- Hematology Oncology Clinic, LLP
- Center for Cancer and Blood Disorders
- National Capital Clinical Research Consortium
- Methodist Cancer Center
- Hematology Oncology Associates of Northern NJ
- Oncology Hematology Care
- Berks Hematology Oncology Associates
- Spartanburg Regional Medical Center
- Chattanooga Oncology Hematology Associates
- Tennessee Oncology, PLLC
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Rituximab
Rituximab/Bevacizumab
All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.
All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.