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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United States

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.

  1. First posted15 Dec 2005 (estimated)

Why it stopped: Withdrawn for poor accrual

Resources

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)
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

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.

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