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Bortezomib and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00265928
Recruitment Status : Terminated (Withdrawn for poor accrual)
First Posted : December 15, 2005
Last Update Posted : January 28, 2008
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: bortezomib Drug: rituximab Procedure: antibody therapy Procedure: biological therapy Procedure: enzyme inhibitor therapy Procedure: monoclonal antibody therapy Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VELCADE (Bortezomib) for Injection - Phase II Study of Bortezomib and Rituximab in Relapsed or Refractory Non-Hodgkin's Lymphoma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00265928

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United States, Virginia
University of Virginia Cancer Center at UV Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
National Cancer Institute (NCI)
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Study Chair: John Densmore, MD University of Virginia
Layout table for additonal information Identifier: NCT00265928    
Other Study ID Numbers: CDR0000459747
First Posted: December 15, 2005    Key Record Dates
Last Update Posted: January 28, 2008
Last Verified: January 2007
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antirheumatic Agents
Molecular Mechanisms of Pharmacological Action