LymphomaPhase 2NCT00081861
Avastin Plus Rituximab for Patients With B-Cell Non-Hodgkin's Lymphoma
A Phase 2 study testing Avastin and Rituximab in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Phase II Study of Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphoma
- What is being tested?
- Avastin and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Sep 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have bi-dimensionally measurable, recurrent or chemotherapy - or Rituxan-refractory aggressive B-cell NHL (Diffuse large B-cell, transformed B-cell lymphoma, or Mantle cell lymphoma)
- Patient who relapse after autologous (not allogeneic) stem cell transplantation are eligible.
- Patients must have had prior Rituximab therapy, with response duration of at least 6 months to the last Rituximab-based therapy (single agent or in combination)
- No anti-lymphoma therapy within the past 3 weeks, and no radiation therapy within 2 weeks.
- Patients must not be eligible for treatment of a higher priority.
- Must have a good performance status (<3 Zubrod, >/=60 Karnofsky).
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- Must have a good marrow reserve: ANC >/=1,000, Platelets >/=75,000.
- Bilirubin </= 2mg/dl, SGOT or SGPT </= x 5 normal values.
- Age > 18 (There is no information about the toxicity of Bevacizumab especially adverse effects on growth and development in pediatric patients).
- Must sign a consent form.
- Must have a life expectancy of > 12 weeks.
Who cannot join
- HIV positive
- History of serious cardiac disease such as myocardial infarction within 6 months of treatment, brady- or tachyarrhythmia, or clinically uncontrolled hypertension (blood pressure >160/110 mmHg).
- Active infection or history of opportunistic infection.
- Pregnant women or breast-feeding women.
- Women of child-bearing age who are not practicing adequate contraception.
- History of prior DVT or pulmonary embolus.
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- INR > 1.5
- Serum creatinine > 2mg/dl, or clinically significant proteinuria (patients with >1+ proteinuria should have 24 hour urine collection and those with >2gm/day should be excluded).
- Evidence of bleeding diathesis or coagulopathy.
- History of other cancers within 5 years except for basal cell carcinoma of the skin.
- Radiotherapy within 14 days of Day 0.
- Current, recent (within 21 days of Day 0), or planned participation in an experimental drug study.
- Hemoglobin <9gm/dl (may be transfused or receive epoetin alfa [e.g., Epogen]to maintain or exceed this level).
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
- Serious, non-healing wound, ulcer, or bone fracture.
- History of CNS disease (including CNS involvement from primary cancer) or hemorrhagic or thrombotic stroke within the last 6 months.
- History of hemoptysis requiring transfusion and/or hospitalization within the last 5 years.
- Anatomic lesion that increase the risk of serious hemorrhage (e.g., invasion of a major vessel by tumor).
- Current, ongoing treatment with full-dose warfarin or its equivalent.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0.
- Fine needle aspirations, indwelling catheter placement, or core biopsy within 7 days prior to Day 0.
- Anticipation of need for major surgical procedure during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Avastin Plus Rituximab for Patients With Relapsed and Chemotherapy- or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
Phase II Study of Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma.
Read the detailed description
Bevacizumab is a new research drug that may help to stop or slow the growth of blood vessels in your tumor. These blood vessels are needed by the tumor to grow. Rituxan is a commercially available drug that is commonly used to treat relapsed and refractory lymphoma.
Before treatment starts, you will be asked questions about your medical history and about any surgeries you have had. You will have a complete physical exam including blood (around 3 tablespoons) and urine tests. You will have a sample of bone marrow collected to learn if the lymphoma has spread to the bone marrow. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. You will have either a CT scan or a MRI of the neck, chest, abdomen, and pelvis, and you will have a gallium or PET scan. You will be asked about any medications that you are taking, including over-the-counter medications. Women who are able to have children must have a negative blood pregnancy test.
Additional blood samples (2 tablespoons) will be collected from you before starting therapy and every 2 months during this study for tests to help your doctors and researchers to learn more about how Bevacizumab works.
During the study, you will be given a dose of rituximab by vein once a week for 8 weeks in a row, and a dose of Bevacizumab every other week. The drugs will be contained in a bag and will be given to you through a needle in one of your veins. This method of giving the drugs is called an infusion. The infusion of Bevacizumab may take 1 to 2 hours, and the infusion of rituximab may take up to 3 to 6 hours. This method of giving a drug is called an infusion. In the first week, infusions of rituxan and Bevacizumab will be given on the same day.
During the infusion of each drug, you will have your vital signs checked often and you will be watched for any side effects. If you experience side effects, the infusion may be slowed down or stopped until the symptoms have gone away.
Within 2 weeks after your 8th dose of rituximab, (4th dose of Bevacizumab) you will have a follow-up visit scheduled to evaluate the status of the disease. During the follow-up visit, you will have a physical exam and blood (around 4 tablespoons) will be collected for lab tests. You will have a CT scan or a MRI, gallium or PET scan, and bone marrow biopsy (if needed). If the disease gets worse or you experience any intolerable side effects, you will be taken off the study. If you are taken off the study or your doctor decides that you should stop study treatment, you will be asked to return to M. D. Anderson for all of the scheduled follow-up visits to check for long term side effects of the drug and to check on the status of the disease.
If the disease remains stable or shrinks after 8 weeks of therapy, you may continue to receive Bevacizumab treatments every 2 weeks for a maximum of a total of 6 months. Even if the treatment is shown to be of benefit to you, your doctor may not continue to give you additional treatments with Bevacizumab beyond the total of 6 months.
After treatment, you will have follow-up visits scheduled to check on the status of the disease. These visits will be scheduled every 3 months for 1 year, then every 4 months for 1 more year, then every 6 months until the disease gets worse. During these visits, you will have a physical exam, blood tests (around 2 tablespoons), and either a CT scan or a MRI. You will also have a sample of bone marrow collected.
This is an investigational study. Bevacizumab has been authorized by the FDA for use in research only. Rituximab is FDA approved and is commercially available. There will be no cost for Bevacizumab or for any tests and procedures that are not considered part of standard of care. Up to 40 patients will take part in this study. All patients will be enrolled at M. D. Anderson.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvastinDrug
Also called Bevacizumab
10 mg/kg given intravenously every 2 weeks for 4 doses.
RituximabDrug
Also called Rituxan
375 mg/m^2 given intravenously weekly for 8 doses, 30 minutes to 1 hour following Bevacizumab.
| Study group | Role | What they receive |
|---|---|---|
| Avastin + Rituximab | Experimental | Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses. Receives: Drug: Avastin; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Response (Complete Response or Progressive Disease)
Response criteria according to the International Working Group Recommendations for lymphoma where Complete Response (CR) defined as "complete disappearance" of clinically detectable disease and Progressive Disease defined by disease appearance by complete blood count (CBC), clinical and radiologic findings, and/or sizes of lymph nodes, spleen, and liver. Response measured from first documentation of response to first detection of progression.
Measured: After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab),
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2004 (estimated)
- Study startMar 2004
- Primary completionSep 2007
- Study completionSep 2007
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 LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Barbara Pro, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081861
- Sponsor's protocol ID
- 2003-0520
- Status last verified
- Apr 2012
- First submitted
- 23 Apr 2004
- Last updated
- 5 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Avastin Plus Rituximab for Patients With Relapsed and Chemotherapy- or Rituxan-Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00081861
- Acronym / sponsor ID
- 2003-0520
- Conditions
- Lymphoma
- Keywords
- Non-Hodgkin's Lymphoma, B-Cell Lymphoma, Lymphoma, Avastin, Bevacizumab, Rituximab, Rituxan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Mar 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 27 Apr 2004 (estimated)
- Results
- Posted 26 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II Study of Avastin Plus Rituximab for Patients with Relapsed and Chemotherapy - or Rituxan Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma.
Detailed description
Bevacizumab is a new research drug that may help to stop or slow the growth of blood vessels in your tumor. These blood vessels are needed by the tumor to grow. Rituxan is a commercially available drug that is commonly used to treat relapsed and refractory lymphoma.
Before treatment starts, you will be asked questions about your medical history and about any surgeries you have had. You will have a complete physical exam including blood (around 3 tablespoons) and urine tests. You will have a sample of bone marrow collected to learn if the lymphoma has spread to the bone marrow. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. You will have either a CT scan or a MRI of the neck, chest, abdomen, and pelvis, and you will have a gallium or PET scan. You will be asked about any medications that you are taking, including over-the-counter medications. Women who are able to have children must have a negative blood pregnancy test.
Additional blood samples (2 tablespoons) will be collected from you before starting therapy and every 2 months during this study for tests to help your doctors and researchers to learn more about how Bevacizumab works.
During the study, you will be given a dose of rituximab by vein once a week for 8 weeks in a row, and a dose of Bevacizumab every other week. The drugs will be contained in a bag and will be given to you through a needle in one of your veins. This method of giving the drugs is called an infusion. The infusion of Bevacizumab may take 1 to 2 hours, and the infusion of rituximab may take up to 3 to 6 hours. This method of giving a drug is called an infusion. In the first week, infusions of rituxan and Bevacizumab will be given on the same day.
During the infusion of each drug, you will have your vital signs checked often and you will be watched for any side effects. If you experience side effects, the infusion may be slowed down or stopped until the symptoms have gone away.
Within 2 weeks after your 8th dose of rituximab, (4th dose of Bevacizumab) you will have a follow-up visit scheduled to evaluate the status of the disease. During the follow-up visit, you will have a physical exam and blood (around 4 tablespoons) will be collected for lab tests. You will have a CT scan or a MRI, gallium or PET scan, and bone marrow biopsy (if needed). If the disease gets worse or you experience any intolerable side effects, you will be taken off the study. If you are taken off the study or your doctor decides that you should stop study treatment, you will be asked to return to M. D. Anderson for all of the scheduled follow-up visits to check for long term side effects of the drug and to check on the status of the disease.
If the disease remains stable or shrinks after 8 weeks of therapy, you may continue to receive Bevacizumab treatments every 2 weeks for a maximum of a total of 6 months. Even if the treatment is shown to be of benefit to you, your doctor may not continue to give you additional treatments with Bevacizumab beyond the total of 6 months.
After treatment, you will have follow-up visits scheduled to check on the status of the disease. These visits will be scheduled every 3 months for 1 year, then every 4 months for 1 more year, then every 6 months until the disease gets worse. During these visits, you will have a physical exam, blood tests (around 2 tablespoons), and either a CT scan or a MRI. You will also have a sample of bone marrow collected.
This is an investigational study. Bevacizumab has been authorized by the FDA for use in research only. Rituximab is FDA approved and is commercially available. There will be no cost for Bevacizumab or for any tests and procedures that are not considered part of standard of care. Up to 40 patients will take part in this study. All patients will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin + Rituximab | Experimental | Drug: Avastin, Drug: RituximabAvastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Must have bi-dimensionally measurable, recurrent or chemotherapy - or Rituxan-refractory aggressive B-cell NHL (Diffuse large B-cell, transformed B-cell lymphoma, or Mantle cell lymphoma)
- Patient who relapse after autologous (not allogeneic) stem cell transplantation are eligible.
- Patients must have had prior Rituximab therapy, with response duration of at least 6 months to the last Rituximab-based therapy (single agent or in combination)
- No anti-lymphoma therapy within the past 3 weeks, and no radiation therapy within 2 weeks.
- Patients must not be eligible for treatment of a higher priority.
Key exclusion criteria (22 listed)
- HIV positive
- History of serious cardiac disease such as myocardial infarction within 6 months of treatment, brady- or tachyarrhythmia, or clinically uncontrolled hypertension (blood pressure >160/110 mmHg).
- Active infection or history of opportunistic infection.
- Pregnant women or breast-feeding women.
- Women of child-bearing age who are not practicing adequate contraception.
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 |
|---|---|---|
| AvastinAlso: Bevacizumab10 mg/kg given intravenously every 2 weeks for 4 doses. | Drug | Avastin + Rituximab |
| RituximabAlso: Rituxan375 mg/m^2 given intravenously weekly for 8 doses, 30 minutes to 1 hour following Bevacizumab. | Drug | Avastin + Rituximab |
Primary outcome
Number of Participants With Response (Complete Response or Progressive Disease)
Time frame: After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab),
Response criteria according to the International Working Group Recommendations for lymphoma where Complete Response (CR) defined as "complete disappearance" of clinically detectable disease and Progressive Disease defined by disease appearance by complete blood count (CBC), clinical and radiologic findings, and/or sizes of lymph nodes, spleen, and liver. Response measured from first documentation of response to first detection of progression.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Barbara Pro, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avastin and Rituximab in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site 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 11 inclusion and 22 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 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 26 Aug 2009). 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?
Number of Participants With Response (Complete Response or Progressive Disease) (time frame: After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab),). 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 Apr 2012.