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

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Lymphoma, Follicular

Treatments: Drug: Bevacizumab; Drug: Rituximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00193492

SCRI LYM 37

U3234s (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Rituximab

Active Comparator group

Description:

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.

Treatment:

Drug: Rituximab

Rituximab/Bevacizumab

Experimental group

Description:

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.

Treatment:

Drug: Rituximab

Drug: Bevacizumab