Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the
      cancer. 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. 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 lenalidomide
      together with rituximab, cyclophosphamide, and dexamethasone may kill more cancer cells.

      PURPOSE: This phase II trial is studying how well giving lenalidomide together with
      rituximab, cyclophosphamide, and dexamethasone works in treating patients with previously
      untreated low-grade non-Hodgkin lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess tumor response to lenalidomide, rituximab, cyclophosphamide, and dexamethasone
           in patients with symptomatic previously untreated low-grade non-Hodgkin lymphoma.

      Secondary

        -  To describe the adverse event profile of this regimen.

        -  To evaluate overall survival, progression-free survival, duration of response, and time
           to treatment failure associated with this regimen.

        -  To estimate tumor response to lenalidomide, rituximab, cyclophosphamide and
           dexamethasone in the subgroup of patients with lymphoplasmacytic lymphoma (Waldenstrom's
           macroglobulinemia).

      OUTLINE: This is a multicenter study.

      Patients receive oral lenalidomide once daily on days 1-21, rituximab IV on day 1, oral
      cyclophosphamide once daily on days 1, 8, and 15, and oral dexamethasone once daily on days
      1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of
      disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed every 3 months for 5 years.
    

Intervention name(s): rituximab; cyclophosphamide; dexamethasone; lenalidomide
Intervention type(s): Biological; Drug; Drug; Drug
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Rituximab; Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I grade 1 follicular lymphoma; contiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 1 follicular lymphoma; stage III grade 1 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage I small lymphocytic lymphoma; contiguous stage II small lymphocytic lymphoma; noncontiguous stage II small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage IV small lymphocytic lymphoma; Waldenstrom macroglobulinemia; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; stage I marginal zone lymphoma; contiguous stage II marginal zone lymphoma; noncontiguous stage II marginal zone lymphoma; stage III marginal zone lymphoma; stage IV marginal zone lymphoma