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

Phase 2
18 Years
Open (Enrolling)
Lymphoma, Follicular

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Outcome 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.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

John D Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

September 2005

Completion Date:

December 2013

Related Keywords:

  • Lymphoma, Follicular
  • Lymphoma
  • Bevacizumab
  • Rituximab
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin



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