Lymphoma, FollicularPhase 2NCT00193492
A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma
A Phase 2 study testing Bevacizumab and Rituximab in people with Lymphoma, Follicular, run by SCRI Development Innovations, LLC at 22 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Follicular
- What is being tested?
- Bevacizumab and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 22 sitesUnited States
- Study dates
- Sep 2005to Mar 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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 locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Medical Oncology Associates of Augusta
Augusta, Georgia, 30901
Hematology Oncology Clinic, LLP
Baton Rouge, Louisiana, 70809
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
National Capital Clinical Research Consortium
Bethesda, Maryland, 20817
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Oncology Hematology Care
Cincinnati, Ohio, 45242
Florida Cancer Specialists
Fort Myers, Florida, 33901
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Integrated Community Oncology Network
Jacksonville, Florida, 32256
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401
Watson Clinic for Cancer Research
Lakeland, Florida, 33805
Baptist Hospital East
Louisville, Kentucky, 40207
Norton Cancer Institute
Louisville, Kentucky, 40207
Wellstar Cancer Research
Marietta, Georgia, 30060
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, 07960
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
Methodist Cancer Center
Omaha, Nebraska, 68114
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Providence Medical Group
Terre Haute, Indiana, 47802
Berks Hematology Oncology Associates
West Reading, Pennsylvania, 19611
About this study
Official title: Rituximab +/- Bevacizumab in the Treatment of Patients With Follicular Non-Hodgkin's Lymphoma: A Randomized, Phase II Trial
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.
Read the 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.
- Conditions
- Lymphoma, Follicular
- Being tested
- Bevacizumab, Rituximab
- Keywords
- Lymphoma, Bevacizumab, Rituximab
- Medical subject headings
- Lymphoma, Follicular, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
RituximabDrug
Also called Rituxan, MabThera
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Active comparator | 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. Receives: Drug: Rituximab |
| Rituximab/Bevacizumab | Experimental | 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. Receives: Drug: Bevacizumab; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphoma, FollicularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- John D Hainsworth, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193492
- Sponsor's protocol ID
- SCRI LYM 37
- Other IDs
- U3234s
- Status last verified
- Dec 2014
- First submitted
- 22 Aug 2005
- Last updated
- 5 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab +/- Bevacizumab in the Treatment of Patients With Follicular Non-Hodgkin's Lymphoma: A Randomized, Phase II Trial
- ClinicalTrials.gov ID
- NCT00193492
- Acronym / sponsor ID
- SCRI LYM 37
- Conditions
- Lymphoma, Follicular
- Keywords
- Lymphoma, Bevacizumab, Rituximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Sep 2005
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 12 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Active comparator | Drug: RituximabAll 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/Bevacizumab | Experimental | Drug: Bevacizumab, Drug: RituximabAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: Avastin | Drug | Rituximab/Bevacizumab |
| RituximabAlso: Rituxan, MabThera | Drug | Rituximab, Rituximab/Bevacizumab |
Primary outcome
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.
1 secondary outcome
Progression Free Survival (PFS)
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Hainsworth, MD principal investigator
SCRI Development Innovations, LLC
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and Rituximab in people with Lymphoma, Follicular, run by SCRI Development Innovations, LLC at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2015.