A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma, Follicular

In brief

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.

Key facts

Study ID

NCT00193492

Run by

SCRI Development Innovations, LLC

People needed

60

Starts

2005-09-01

Expected to finish

2013-03-01

Last updated by the study team

2015-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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.

Where it is running

• Northeast Arkansas Clinic — Jonesboro, Arkansas, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Integrated Community Oncology Network — Jacksonville, Florida, United States
• Watson Clinic for Cancer Research — Lakeland, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Medical Oncology Associates of Augusta — Augusta, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Wellstar Cancer Research — Marietta, Georgia, United States
• Providence Medical Group — Terre Haute, Indiana, United States
• Graves-Gilbert Clinic — Bowling Green, Kentucky, United States
• Baptist Hospital East — Louisville, 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
• Methodist Cancer Center — Omaha, Nebraska, United States
• Hematology Oncology Associates of Northern NJ — Morristown, New Jersey, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Berks Hematology Oncology Associates — West Reading, Pennsylvania, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• Chattanooga Oncology Hematology Associates — Chattanooga, Tennessee, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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