Lymphoma, Follicular
Conditions
Keywords
Lymphoma, Bevacizumab, Rituximab
Brief summary
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.
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.
Interventions
DRUGBevacizumab
DRUGRituximab
Sponsors
Genentech, Inc.
SCRI Development Innovations, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Rituximab | 31 |
| 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.
Bevacizumab
Rituximab | 29 |
| Total | 60 |
Baseline characteristics
| Characteristic | Rituximab | Rituximab/Bevacizumab | Total |
|---|---|---|---|
| Age, Continuous | 65 years | 68 years | 67 years |
| Region of Enrollment United States | 31 participants | 29 participants | 60 participants |
| Sex: Female, Male Female | 13 Participants | 16 Participants | 29 Participants |
| Sex: Female, Male Male | 18 Participants | 13 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 29 / 31 | 29 / 29 |
| serious Total, serious adverse events | 1 / 31 | 8 / 29 |
Outcome results
Primary
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
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.
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | 42 percentage of participants |
| Rituximab/Bevacizumab | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment | 48 percentage of participants |
Secondary
Progression Free Survival (PFS)
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.
Time frame: 18 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rituximab | Progression Free Survival (PFS) | 10.4 months |
| Rituximab/Bevacizumab | Progression Free Survival (PFS) | 20.7 months |