A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Sarah Cannon Research Institute
Collaborator:
Genentech
Information provided by (Responsible Party):
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193492
First received: August 22, 2005
Last updated: April 4, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Follicular |
Drug: Bevacizumab Drug: Rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rituximab +/- Bevacizumab in the Treatment of Patients With Follicular Non-Hodgkin's Lymphoma: A Randomized, Phase II Trial |
Resource links provided by NLM:
Further study details as provided by Sarah Cannon Research Institute:
Primary Outcome Measures:
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]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 Worsening of Their Disease or Death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
Drug: Rituximab
Other Names:
|
|
Experimental: 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.
|
Drug: Bevacizumab
Other Name: Avastin
Drug: Rituximab
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193492
Locations
| United States, Arkansas | |
| Northeast Arkansas Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, Florida | |
| Florida Cancer Specialists | |
| Fort Myers, Florida, United States, 33901 | |
| Integrated Community Oncology Network | |
| Jacksonville, Florida, United States, 32256 | |
| Watson Clinic for Cancer Research | |
| Lakeland, Florida, United States, 33805 | |
| Florida Hospital Cancer Institute | |
| Orlando, Florida, United States, 32804 | |
| United States, Georgia | |
| Medical Oncology Associates of Augusta | |
| Augusta, Georgia, United States, 30901 | |
| Northeast Georgia Medical Center | |
| Gainesville, Georgia, United States, 30501 | |
| Wellstar Cancer Research | |
| Marietta, Georgia, United States, 30060 | |
| United States, Indiana | |
| Providence Medical Group | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Kentucky | |
| Graves-Gilbert Clinic | |
| Bowling Green, Kentucky, United States, 42101 | |
| Baptist Hospital East | |
| Louisville, Kentucky, United States, 40207 | |
| Norton Cancer Institute | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Louisiana | |
| Hematology Oncology Clinic, LLP | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| National Capital Clinical Research Consortium | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Nebraska | |
| Methodist Cancer Center | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New Jersey | |
| Hematology Oncology Associates of Northern NJ | |
| Morristown, New Jersey, United States, 07960 | |
| United States, Ohio | |
| Oncology Hematology Care | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Pennsylvania | |
| Berks Hematology Oncology Associates | |
| West Reading, Pennsylvania, United States, 19611 | |
| United States, South Carolina | |
| Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| Chattanooga Oncology Hematology Associates | |
| Chattanooga, Tennessee, United States, 37404 | |
| Tennessee Oncology, PLLC | |
| Nashville, Tennessee, United States, 37023 | |
Sponsors and Collaborators
Sarah Cannon Research Institute
Genentech
Investigators
| Principal Investigator: | John D Hainsworth, MD | Sarah Cannon Research Institute |
More Information
No publications provided
| Responsible Party: | Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00193492 History of Changes |
| Other Study ID Numbers: | SCRI LYM 37, U3234s |
| Study First Received: | August 22, 2005 |
| Last Updated: | April 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sarah Cannon Research Institute:
|
Lymphoma Bevacizumab Rituximab |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab Bevacizumab |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013