LymphomaPhase 2NCT00265928
Bortezomib and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
A Phase 2 study testing bortezomib, rituximab and antibody therapy in people with Lymphoma, run by University of Virginia at 1 site in United States.
Trial summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- bortezomib, rituximab and antibody therapy
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) including the following subtypes:
- B-cell small lymphocytic lymphoma
- Marginal zone lymphoma (extranodal, nodal, or splenic)
- Grade 1-3 follicular lymphoma
- Mantle cell lymphoma
- Waldenstrom's macroglobulinemia
- Bidimensionally measurable disease by CT scan with ≥ 1 lesion measuring > 1.5 cm in a single dimension
- Relapsed or refractory disease after prior antineoplastic therapy, meeting 1 of the following criteria:
- No response to prior treatment
- Relapsed disease after prior therapy
- Confirmed CD20-positive disease by immunohistochemistry on biopsy specimen
- Prior transformation allowed provided there is no evidence of aggressive histology on recent biopsy
- No chronic lymphocytic lymphoma with absolute lymphocyte count > 5,000/mm³
- No CNS involvement
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1,500/mm^3 (≥ 1,000/mm³ if due to extensive bone marrow involvement with NHL or splenomegaly)
- Absolute lymphocyte count ≤ 5,000/mm³ (except mantle cell lymphoma with a leukemic phase)
- Platelet count ≥ 50,000/mm^3
- Bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (4 times ULN if liver involvement with NHL)
- Creatinine ≤ 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile male and female patients must use effective contraception during study
- No serious nonmalignant disease
- No active infection
- No peripheral neuropathy ≥ grade 2 within past 14 days
- No myocardial infarction within the past 6 months
- No New York Heart Association class III or IV heart failure
- No uncontrolled angina pectoris
- No severe uncontrolled ventricular arrhythmias
- No EKG evidence of acute ischemia or active conduction system abnormalities
- Any EKG abnormality must be documented as not medically relevant
- No hypersensitivity to bortezomib, boron, or mannitol
- No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins or any component of rituximab (including polysorbate 80 and sodium citrate dehydrate)
- No known infection or exposure to HIV
- No serious psychiatric or medical illness that would preclude study participation
- No active hepatitis B infection
- No other primary malignancy requiring active treatment
- More than 4 weeks since prior significant traumatic injury
PRIOR CONCURRENT THERAPY:
- At least 3 weeks since prior and no concurrent radiotherapy
- More than 4 weeks since prior major surgery or open biopsy
- Other diagnostic surgery allowed
- More than 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas)
- At least 3 months since prior unconjugated monoclonal antibody therapy
- At least 10 weeks since prior radioimmunoconjugates or toxin immunoconjugates (e.g., iodine I 131 tositumomab [Bexxar] or ibritumomab tiuxetan [Zevalin])
- More than 2 weeks since prior investigational agent
- No prior bortezomib
- No concurrent systemic corticosteroid at greater than the equivalent dose of 20 mg/day of prednisone, unless for treatment of allergic reactions to CT scan dye
- No concurrent major surgery
- No other immunosuppressive agents, unless for treatment of allergic reactions to CT scan dye
- No other concurrent antilymphoma agents
- No other concurrent investigational agent
- Concurrent participation in another nontreatment study allowed if it does not interfere with participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Cancer Center at UV Health System
Charlottesville, Virginia, 22908
About this study
Official title: VELCADE (Bortezomib) for Injection - Phase II Study of Bortezomib and Rituximab in Relapsed or Refractory Non-Hodgkin's Lymphoma
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma, including Waldenstrom's macroglobulinemia.
Read the detailed description
OBJECTIVES:
Primary
- Assess the safety and tolerability of bortezomib and rituximab in patients with relapsed or refractory, B-cell non-Hodgkin's lymphoma.
- Determine the overall response rate (partial response, complete response unconfirmed, and complete response) in these patients.
Secondary
- Estimate the duration of response in patients treated with this regimen.
- Estimate the time to disease progression in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV over 3-5 seconds once weekly in weeks 1-4 and rituximab IV over 5-6 hours once weekly in weeks 1-5*. Treatment repeats every 5 weeks for 2 courses. Patients achieving stable disease or better receive an additional 4 courses of bortezomib alone.
NOTE: *Patients receive rituximab in weeks 1-3 only during course 2 of treatment.
After completion of study treatment, patients are followed periodically for at least 18 months.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- bortezomib, rituximab, antibody therapy, biological therapy, enzyme inhibitor therapy
- Keywords
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, splenic marginal zone lymphoma, recurrent adult diffuse small cleaved cell lymphoma, nodal marginal zone B-cell lymphoma, Waldenstrom's macroglobulinemia
- Medical subject headings
- Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
rituximabDrug
antibody therapyProcedure or surgery
biological therapyProcedure or surgery
enzyme inhibitor therapyProcedure or surgery
monoclonal antibody therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
Why it stopped: Withdrawn for poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- John Densmore, MD, Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265928
- Sponsor's protocol ID
- CDR0000459747
- Other IDs
- UVACC-HIC-12077, UVACC-PRC-36805, MILLENNIUM-X05181, MILLENNIUM-LYMPHOMA2
- Status last verified
- Jan 2007
- First submitted
- 14 Dec 2005
- Last updated
- 28 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VELCADE (Bortezomib) for Injection - Phase II Study of Bortezomib and Rituximab in Relapsed or Refractory Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00265928
- Acronym / sponsor ID
- CDR0000459747
- Conditions
- Lymphoma
- Keywords
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, splenic marginal zone lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Withdrawn for poor accrual
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 15 Dec 2005 (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.
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib together with rituximab may be an effective treatment for non-Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma, including Waldenstrom's macroglobulinemia.
Detailed description
OBJECTIVES:
Primary
- Assess the safety and tolerability of bortezomib and rituximab in patients with relapsed or refractory, B-cell non-Hodgkin's lymphoma.
- Determine the overall response rate (partial response, complete response unconfirmed, and complete response) in these patients.
Secondary
- Estimate the duration of response in patients treated with this regimen.
- Estimate the time to disease progression in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV over 3-5 seconds once weekly in weeks 1-4 and rituximab IV over 5-6 hours once weekly in weeks 1-5*. Treatment repeats every 5 weeks for 2 courses. Patients achieving stable disease or better receive an additional 4 courses of bortezomib alone.
NOTE: *Patients receive rituximab in weeks 1-3 only during course 2 of treatment.
After completion of study treatment, patients are followed periodically for at least 18 months.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| bortezomib | Drug | – |
| rituximab | Drug | – |
| antibody therapy | Procedure or surgery | – |
| biological therapy | Procedure or surgery | – |
| enzyme inhibitor therapy | Procedure or surgery | – |
| monoclonal antibody therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Withdrawn for poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 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.
John Densmore, MD study chair
University of Virginia
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 bortezomib, rituximab and antibody therapy in people with Lymphoma, run by University of Virginia 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?
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: stopped early, as of the sponsor's last update on 28 Jan 2008. 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?
The study was stopped early (reason given: Withdrawn for poor accrual). Results are not available in the source record.
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 28 Jan 2008.