A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma
Rituximab +/- Bevacizumab in the Treatment of Patients With Follicular Non-Hodgkin's Lymphoma: A Randomized, Phase II Trial
2 other identifiers
interventional
60
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2005
Longer than P75 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2005
CompletedStudy Start
First participant enrolled
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
December 12, 2014
CompletedJanuary 5, 2015
December 1, 2014
7.5 years
August 22, 2005
December 5, 2014
December 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
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.
18 months
Secondary Outcomes (1)
Progression Free Survival (PFS)
18 months
Study Arms (2)
Rituximab
ACTIVE COMPARATORAll 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
EXPERIMENTALAll 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.
Interventions
Eligibility Criteria
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Genentech, Inc.collaborator
Study Sites (22)
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Integrated Community Oncology Network
Jacksonville, Florida, 32256, United States
Watson Clinic for Cancer Research
Lakeland, Florida, 33805, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Medical Oncology Associates of Augusta
Augusta, Georgia, 30901, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Wellstar Cancer Research
Marietta, Georgia, 30060, United States
Providence Medical Group
Terre Haute, Indiana, 47802, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Baptist Hospital East
Louisville, Kentucky, 40207, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Hematology Oncology Clinic, LLP
Baton Rouge, Louisiana, 70809, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
National Capital Clinical Research Consortium
Bethesda, Maryland, 20817, United States
Methodist Cancer Center
Omaha, Nebraska, 68114, United States
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, 07960, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Berks Hematology Oncology Associates
West Reading, Pennsylvania, 19611, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Hainsworth MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
John D Hainsworth, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2005
First Posted
September 19, 2005
Study Start
September 1, 2005
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
January 5, 2015
Results First Posted
December 12, 2014
Record last verified: 2014-12