B-Cell LymphomaPhase 2NCT00085696
VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
A Phase 2 study testing VELCADE and rituximab in people with B-Cell Lymphoma and Follicular Lymphoma, run by Millennium Pharmaceuticals, Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Lymphoma, Follicular Lymphoma, Marginal Lymphoma
- What is being tested?
- VELCADE and rituximab
- How many people
- 66 participants
- Where
- 13 sitesUnited States
- Study dates
- May 2004to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female subject 18 years or older
- Diagnosis of B-cell lymphoma (CD20+) of
- follicular lymphoma (grades 1, 2, and 3) or
- marginal zone lymphoma (extranodal, nodal, and splenic)
- Documented relapse or progression following prior anti-neoplastic treatment.
- At least 1 measurable lymph node mass that is >1.5 cm.
- No active CNS lymphoma
- Voluntary consent
Who cannot join
- Previous treatment with VELCADE
- Any anti-neoplastic or experimental therapy within 3 weeks before the first dose of study drug.
- Any treatment with nitrosoureas within 6 weeks before the first dose of study drug.
- Treatment with Zevalin™ or Bexxar® within 10 weeks before the first dose of study drug.
- Rituximab, Campath® or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug.
- Radiation therapy within 3 weeks before the first dose of study drug.
Show all 16Show fewer
- Major surgery within 2 weeks before the first dose of study drug.
- Peripheral neuropathy or neuropathic pain
- History of allergic reaction attributable to compounds containing boron or mannitol
- Known anaphylaxis or hypersensitivity to any component of rituximab
- Diagnosed or treated for a selected malignancies other than NHL within 5 years.
- Active systemic infection requiring treatment
- Female subjects must not be pregnant, breast-feeding, or become pregnant during the course of the study.
- Male subjects who do not agree to use an acceptable method of contraception for the duration of the study
- Any serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Emory University Cancer Institute, Winship Cancer Institute
Atlanta, Georgia, 30322
Charleston Cancer Center
Charleston, South Carolina, 29406
Rush University Medical Center
Chicago, Illinois, 60612
Mid Ohio Oncology/Hematology Inc.
Columbus, Ohio, 43213
FNVHO - US Oncology
Fairfax, Virginia, 20031
Florida Cancer Specialists
Fort Myers, Florida, 33901
MD Anderson Cancer Center
Houston, Texas, 77030
Oncology/Henmatology Associates of Kansas City
Kansas City, Missouri, 64111
UCLA School of Medicine
Los Angeles, California, 90095
Georgia Cancer Specialists
Marietta, Georgia, 30060
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Midwest Cancer Research Group
Skokie, Illinois, 60077
Cancer Center of Kansas
Wichita, Kansas, 67214
About this study
Official title: A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.
- Conditions
- B-Cell Lymphoma, Follicular Lymphoma, Marginal Lymphoma
- Being tested
- VELCADE and rituximab
- Keywords
- Lymphoma, Non-Hodgkin's, NHL, B-Cell, Indolent
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VELCADE and rituximabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2004 (estimated)
- Study startMay 2004
- Primary completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell LymphomaStudies 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
- 66 participants
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085696
- Sponsor's protocol ID
- M34103-061
- Status last verified
- Feb 2008
- First submitted
- 11 Jun 2004
- Last updated
- 11 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00085696
- Acronym / sponsor ID
- M34103-061
- Conditions
- B-Cell Lymphoma, Follicular Lymphoma, Marginal Lymphoma
- Keywords
- Lymphoma, Non-Hodgkin's, NHL, B-Cell, Indolent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Apr 2006 (actual)
- First posted
- 15 Jun 2004 (estimated)
- Results
- Not posted in the source record
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 evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subject 18 years or older
- Diagnosis of B-cell lymphoma (CD20+) of
- Documented relapse or progression following prior anti-neoplastic treatment.
- At least 1 measurable lymph node mass that is >1.5 cm.
- No active CNS lymphoma
Key exclusion criteria (16 listed)
- Previous treatment with VELCADE
- Any anti-neoplastic or experimental therapy within 3 weeks before the first dose of study drug.
- Any treatment with nitrosoureas within 6 weeks before the first dose of study drug.
- Treatment with Zevalin™ or Bexxar® within 10 weeks before the first dose of study drug.
- Rituximab, Campath® or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug.
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 |
|---|---|---|
| VELCADE and rituximab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 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 VELCADE and rituximab in people with B-Cell Lymphoma and Follicular Lymphoma, run by Millennium Pharmaceuticals, Inc. at 13 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 8 inclusion and 16 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 11 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 11 Feb 2008.