Lenalidomide in Combination With Rituximab in Treating Participants With Stage III/IV Indolent Non-Hodgkin Lymphoma
Condition: Ann Arbor Stage III Grade 1 Follicular Lymphoma; Ann Arbor Stage III Grade 2 Follicular Lymphoma; Ann Arbor Stage III Indolent Adult Non-Hodgkin Lymphoma; Ann Arbor Stage III Marginal Zone Lymphoma; Ann Arbor Stage III Small Lymphocytic Lymphoma; Ann Arbor Stage IV Grade 1 Follicular Lymphoma; Ann Arbor Stage IV Grade 2 Follicular Lymphoma; Ann Arbor Stage IV Indolent Adult Non-Hodgkin Lymphoma; Ann Arbor Stage IV Marginal Zone Lymphoma; Ann Arbor Stage IV Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Lenalidomide; Rituximab
Intervention description: Given PO; Given IV
Intervention MeSH terms: Rituximab; Antineoplastic Agents, Immunological; Lenalidomide; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well lenalidomide works in combination with rituximab in
      treating participants with stage III-IV non-Hodgkin lymphoma that is growing slowly.
      Lenalidomide is designed to change the body's immune system. It may also interfere with the
      development of tiny blood vessels that help support tumor growth, which may prevent the
      growth of cancer cells. Monoclonal antibodies, such as rituximab, may interfere with the
      ability of cancer cells to grow and spread. Giving lenalidomide and rituximab may work better
      in participants with indolent non-Hodgkin lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Understand and voluntarily sign an informed consent form.

          2. Age >/= 18 at the time of signing the informed consent form.

          3. Able to adhere to the study visit schedule and other protocol requirements.

          4. Untreated indolent non-Hodgkin's lymphoma stage III-IV including small lymphocytic
             lymphoma, marginal zone lymphoma, grade 1 or 2 follicular lymphoma. (prior radiation
             for localized disease allowed).

          5. At least one measurable lesion according to the International workshop standardized
             response criteria for non-Hodgkin's lymphomas (IWG) greater than 1.5cm.

          6. ECOG performance status of </= 2 at study entry.

          7. Laboratory test results within these ranges: Absolute neutrophil count >/= 1.5 x
             10^9/L; Platelet count >/=100 x 10^9/L; Serum creatinine </= 2.0 mg/dL; Total
             bilirubin </=1.5 mg/dL; AST (SGOT) and ALT (SGPT) </=2 x ULN or </=5 x ULN if hepatic
             metastases are present.

          8. Disease free of prior malignancies for >/= 5 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix
             or breast, or localized prostate cancer treated with curative intent.

          9. All study participants must be registered into the mandatory RevAssist® program, and
             be willing and able to comply with the requirements of RevAssist®.

         10. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
             test with a sensitivity of at least 50 mIU/mL within 10 -14 days prior to and again
             within 24 hours of prescribing lenalidomide and must either commit to continued
             abstinence from heterosexual intercourse or begin TWO acceptable methods of birth
             control, one highly effective method and one additional effective method AT THE SAME
             TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to
             ongoing pregnancy testing.

         11. Men must agree to use a latex condom during sexual contact with a female of child
             bearing potential even if they have had a successful vasectomy.

         12. For patients with bulky disease (tumors >5cm) must be able to take aspirin (81 mg or
             325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use
             warfarin or low molecular weight heparin.

        Exclusion Criteria:

          1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          2. Pregnant or breast feeding females.

          3. Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          4. Use of any chemotherapy or experimental therapy within 28 days of enrollment.

          5. Known hypersensitivity to thalidomide.

          6. The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          7. Any prior use of lenalidomide.

          8. Concurrent use of other anti-cancer agents or experimental treatments.

          9. Known positive for HIV or infectious hepatitis type B or C. (Hepatitis B core antibody
             can be positive if Hep B surface antigen is negative and no HBV DNA in blood,
             indicating a cleared infection.)