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Completed

NCT Number: NCT00193492

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northeast Arkansas Clinic, Jonesboro, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bevacizumab

Drug

Other names: Avastin

Rituximab

Drug

Other names: Rituxan, MabThera

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Sep 19, 2005
Registry last updated
Jan 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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