A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma
- Registration Number
- NCT00193492
- Lead Sponsor
- SCRI Development Innovations, LLC
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rituximab/Bevacizumab Bevacizumab 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. Rituximab Rituximab 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. Rituximab/Bevacizumab Rituximab 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.
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment 18 months Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) 18 months The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death or Disease Progression from NHL. Progression is defined using International Workshop Response Criteria for Non-Hodgkin's Lymphoma as - enlargment of liver/spleen, new sites, new or increased malignancy in lymph nodes, new or increased lymph node masses or reappearance of disease in bone marrow.
Trial Locations
- Locations (22)
Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Chattanooga Oncology Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
Integrated Community Oncology Network
🇺🇸Jacksonville, Florida, United States
Northeast Arkansas Clinic
🇺🇸Jonesboro, Arkansas, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Watson Clinic for Cancer Research
🇺🇸Lakeland, Florida, United States
Medical Oncology Associates of Augusta
🇺🇸Augusta, Georgia, United States
Wellstar Cancer Research
🇺🇸Marietta, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Providence Medical Group
🇺🇸Terre Haute, Indiana, United States
Baptist Hospital East
🇺🇸Louisville, Kentucky, United States
Graves-Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Hematology Oncology Clinic, LLP
🇺🇸Baton Rouge, Louisiana, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
National Capital Clinical Research Consortium
🇺🇸Bethesda, Maryland, United States
Hematology Oncology Associates of Northern NJ
🇺🇸Morristown, New Jersey, United States
Methodist Cancer Center
🇺🇸Omaha, Nebraska, United States
Berks Hematology Oncology Associates
🇺🇸West Reading, Pennsylvania, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States