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

Lymphoma, Follicular Clinical Trial

Official title:

Rituximab +/- Bevacizumab in the Treatment of Patients With Follicular Non-Hodgkin's Lymphoma: A Randomized, Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193492
• Other study ID #: SCRI LYM 37
• Secondary ID: U3234s
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2005
• Last updated: December 11, 2014
• Start date: September 2005
• Est. completion date: March 2013

Study information

• Verified date: December 2014
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Bevacizumab

• Rituximab

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Progression Free Survival (PFS)	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.	18 months	No