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

December 11, 2014 updated by: SCRI Development Innovations, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Northeast Arkansas Clinic
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
      • Jacksonville, Florida, United States, 32256
        • Integrated Community Oncology Network
      • Lakeland, Florida, United States, 33805
        • Watson Clinic for Cancer Research
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Medical Oncology Associates of Augusta
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Medical Center
      • Marietta, Georgia, United States, 30060
        • Wellstar Cancer Research
    • Indiana
      • Terre Haute, Indiana, United States, 47802
        • Providence Medical Group
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves-Gilbert Clinic
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute
      • Louisville, Kentucky, United States, 40207
        • Baptist Hospital East
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology Oncology Clinic, LLP
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer and Blood Disorders
      • Bethesda, Maryland, United States, 20817
        • National Capital Clinical Research Consortium
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Methodist Cancer Center
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Hematology Oncology Associates of Northern NJ
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19611
        • Berks Hematology Oncology Associates
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Oncology Hematology Associates
      • Nashville, Tennessee, United States, 37023
        • Tennessee Oncology, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Rituximab
Other Names:
  • Rituxan
  • MabThera
Drug: Bevacizumab
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Time Frame: 18 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCRI Development Innovations, LLC

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: John D Hainsworth, MD, SCRI Development Innovations, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 5, 2015

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRI LYM 37
  • U3234s (Other Identifier: Genentech-Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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