A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00193492 |
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Recruitment Status :
Completed
First Posted : September 19, 2005
Results First Posted : December 12, 2014
Last Update Posted : January 5, 2015
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Sponsor:
SCRI Development Innovations, LLC
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, Follicular | Drug: Bevacizumab Drug: Rituximab | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Rituximab +/- Bevacizumab in the Treatment of Patients With Follicular Non-Hodgkin's Lymphoma: A Randomized, Phase II Trial |
| Study Start Date : | September 2005 |
| Actual Primary Completion Date : | March 2013 |
| Actual Study Completion Date : | March 2013 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Rituximab
Other Names:
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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.
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Drug: Bevacizumab
Other Name: Avastin Drug: Rituximab Other Names:
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Primary Outcome Measures :
- 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 Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193492
Locations
Show 22 study locations
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Investigators
| Principal Investigator: | John D Hainsworth, MD | SCRI Development Innovations, LLC |
| Responsible Party: | SCRI Development Innovations, LLC |
| ClinicalTrials.gov Identifier: | NCT00193492 |
| Other Study ID Numbers: |
SCRI LYM 37 U3234s ( Other Identifier: Genentech-Roche ) |
| First Posted: | September 19, 2005 Key Record Dates |
| Results First Posted: | December 12, 2014 |
| Last Update Posted: | January 5, 2015 |
| Last Verified: | December 2014 |
Keywords provided by SCRI Development Innovations, LLC:
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Lymphoma Bevacizumab Rituximab |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bevacizumab |
Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Immunologic Factors Antirheumatic Agents |