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

NCT ID: NCT00193492

Last Updated: 2015-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2013-03-31

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.

Conditions

Lymphoma, Follicular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: DRUG

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). 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.

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Rituximab

Intervention Type: DRUG

Interventions

Bevacizumab

Intervention Type: DRUG

Rituximab

Intervention Type: DRUG

Other Intervention Names

Avastin; Rituxan; MabThera

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John D Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

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

Countries

United States

Other Identifiers

U3234s

Identifier Type: OTHER

Identifier Source: secondary_id

SCRI LYM 37

Identifier Type: -

Identifier Source: org_study_id