Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: rituximab; cyclophosphamide; dexamethasone; lenalidomide
Intervention MeSH terms: Dexamethasone; Cyclophosphamide; Rituximab; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed symptomatic non-Hodgkin lymphoma by biopsy within the past 6
             months

               -  Any of the following subtypes allowed:

                    -  Grade 1 or 2 lymphoma

                    -  Small lymphocytic lymphoma

                    -  Marginal zone lymphoma

                    -  Lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia [WM])

          -  Previously untreated disease that, in the investigator's opinion, requires treatment

          -  Measurable disease by CT or MRI scans with lymph nodes ≥ 2.0 cm in ≥ 1 dimension

               -  WM patients without lymphadenopathy must meet the following criteria:

                    -  More than 10% lymphocytes, lymphoplasmacytic cells, or plasma cells on a
                       bone marrow aspirate/biopsy

                    -  Quantitative Immunoglobulin M ≥ 400 mg/dL NOTE: A new classification scheme
                       for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of
                       "indolent" or "aggressive" lymphoma will replace the former terminology of
                       "low", "intermediate", or "high" grade lymphoma. However, this protocol uses
                       the former terminology.

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  ANC ≥ 1,400/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine ≤ 2.0 mg/dL

          -  Total or direct bilirubin ≤ 1.5 mg/dL

          -  AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases
             are present)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective double-method contraception at least 28 days prior
             to, during, and for 28 days after completion of study therapy

          -  Able to take acetylsalicylic acid (ASA) 325 mg/day as prophylactic anticoagulation
             (patients intolerant to ASA may use warfarin or low molecular weight heparin)

          -  No known hypersensitivity to thalidomide

          -  No development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs

          -  No uncontrolled intercurrent illness including, but not limited to, any of the
             following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure requiring use of ongoing maintenance therapy
                  for life-threatening ventricular arrhythmias

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness or social situations that would limit compliance with study
                  requirements

          -  No myocardial infarction within the past 6 months

          -  No other active malignancy requiring treatment, except for localized nonmelanomatous
             skin cancer or any cancer that, in the judgement of the investigator, has been treated
             with curative intent and will not interfere with the study treatment plan and response
             assessment

          -  No co-morbid systemic illnesses or other severe concurrent disease which, in the
             judgement of the investigator, would make the patient inappropriate for entry into the
             study or would interfere significantly with the proper assessment of safety and
             toxicity of study treatment

          -  No known positivity for HIV or infectious hepatitis A, B, or C

          -  No serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the patient from signing the informed consent

          -  Willing to return to Mayo Clinic enrolling institution for follow up

          -  Registered into the RevAssist® program and willing and able to comply with the
             requirements of RevAssist®

        PRIOR CONCURRENT THERAPY:

          -  No prior lenalidomide

          -  No prior irradiation to ≥ 25% of the bone marrow

          -  More than 28 days since prior experimental drug or therapy

          -  No concurrent radiotherapy, chemotherapy, or immunotherapy

          -  No other concurrent anticancer agents or treatments, including thalidomide or
             investigational agents