Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients with Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma

Overview

About this study

RATIONALE: 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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide together with bortezomib and dexamethasone works in treating patients with relapsed or refractory low-grade follicular lymphoma, Waldenstrom macroglobulinemia, or mantle cell lymphoma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

DISEASE CHARACTERISTICS:

  • Histologically confirmed relapsed or refractory follicular lymphoma (grade I or II), mantle cell lymphoma (MCL), or lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia [WM])
    • MCL confirmed by cyclin D1 staining or fluorescent in situ hybridization [t(11;14)]
  • Measurable disease, defined as lymph nodes ≥ 2.0 cm in at least one dimension by CT scan, PET/CT scan, or MRI
    • Patients with WM without lymphadenopathy must have > 10% lymphocytes, lymphoplasmacytic cells, or plasma cells on a bone marrow aspirate/biopsy AND quantitative IgM ≥ 400 mg/dL

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy > 3 months
  • ANC ≥ 1,200/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin ≤ 2.0 mg/dL
  • Alkaline phosphatase ≤ 3 times ULN
  • AST ≤ 3 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would exclude the patient from participating in this study or would interfere significantly with the proper assessment of safety and adverse events of the prescribed study regimen
  • No known HIV positivity
  • No concurrent uncontrolled illness including, but not limited to, any of the following:
    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable or uncontrolled angina pectoris
    • Cardiac arrhythmias, including severe uncontrolled ventricular arrhythmias
    • Psychiatric illness/social situation that would preclude compliance with study requirements
  • No hypersensitivity to bortezomib, boron, or mannitol
  • No myocardial infarction within the past 6 months
  • No NYHA class III-IV heart failure
  • No evidence of acute ischemia by ECG
  • No active conduction system abnormalities
  • No other malignancy within the past 3 years, except for the following:
    • Completely resected basal cell or squamous cell carcinoma of the skin
    • In situ malignancy
    • Curatively treated prostate cancer deemed to be at low risk

PRIOR CONCURRENT THERAPY:

  • More than 14 days since prior investigational drugs
  • At least 4 weeks since prior anticancer therapy, including radiotherapy, hormonal therapy, or surgery
  • No other concurrent investigational agents as treatment for the primary malignancy
  • No concurrent therapy for other malignancies, except hormonal therapy

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Craig Reeder, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Craig Reeder, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20116744

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