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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193492
First received: August 22, 2005
Last updated: May 2, 2014
Last verified: May 2014
  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 SCRI Development Innovations, LLC:

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 ]

Enrollment: 60
Study Start Date: September 2005
Study Completion Date: March 2013
Primary Completion Date: March 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:
  • Rituxan
  • MabThera
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:
  • Rituxan
  • MabThera

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
SCRI Development Innovations, LLC
Genentech, Inc.
Investigators
Principal Investigator: John D Hainsworth, MD SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193492     History of Changes
Other Study ID Numbers: SCRI LYM 37, U3234s
Study First Received: August 22, 2005
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
Lymphoma
Bevacizumab
Rituximab

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bevacizumab
Rituximab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Antirheumatic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014