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

Primary Purpose

Lymphoma, Follicular

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Rituximab
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Follicular focused on measuring Lymphoma, Bevacizumab, Rituximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northeast Arkansas Clinic
  • Florida Cancer Specialists
  • Integrated Community Oncology Network
  • Watson Clinic for Cancer Research
  • Florida Hospital Cancer Institute
  • Medical Oncology Associates of Augusta
  • Northeast Georgia Medical Center
  • Wellstar Cancer Research
  • Providence Medical Group
  • Graves-Gilbert Clinic
  • Baptist Hospital East
  • Norton Cancer Institute
  • Hematology Oncology Clinic, LLP
  • Center for Cancer and Blood Disorders
  • National Capital Clinical Research Consortium
  • Methodist Cancer Center
  • Hematology Oncology Associates of Northern NJ
  • Oncology Hematology Care
  • Berks Hematology Oncology Associates
  • Spartanburg Regional Medical Center
  • Chattanooga Oncology Hematology Associates
  • Tennessee Oncology, PLLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rituximab

Rituximab/Bevacizumab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 22, 2005
Last Updated
December 11, 2014
Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00193492
Brief Title
A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma
Official Title
Rituximab +/- Bevacizumab in the Treatment of Patients With Follicular Non-Hodgkin's Lymphoma: A Randomized, Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Follicular
Keywords
Lymphoma, Bevacizumab, Rituximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Rituximab/Bevacizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Hainsworth, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northeast Arkansas Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Integrated Community Oncology Network
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Watson Clinic for Cancer Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Medical Oncology Associates of Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Wellstar Cancer Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Providence Medical Group
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Graves-Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Baptist Hospital East
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Hematology Oncology Clinic, LLP
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
National Capital Clinical Research Consortium
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Methodist Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Hematology Oncology Associates of Northern NJ
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Berks Hematology Oncology Associates
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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