Rituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Intervention: rituximab; lenalidomide
Intervention description: Given IV; Given orally
Intervention MeSH terms: Rituximab; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma

Summary:

      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. Biological therapies, such as lenalidomide,
      may stimulate the immune system in different ways and stop cancer cells from growing.
      Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the
      cancer. Giving rituximab together with lenalidomide may kill more cancer cells. This
      randomized phase II trial is studying how well rituximab and/or lenalidomide work in treating
      patients with follicular non-Hodgkin's lymphoma that is not refractory to rituximab.
    

Eligibility criteria:

        -  Documentation of Disease

               -  Previously treated, histologically confirmed follicle center cell lymphoma, World
                  Health Organization (WHO) classification, grade 1, 2, or 3a

               -  Institutional flow cytometry or immunohistochemistry must confirm Cluster of
                  Differentiation 20 (CD20) antigen expression.

          -  Prior Treatment

               -  Patient must have been treated with rituximab either alone or in combination with
                  chemotherapy.

               -  Patient must have a time to progression of ≥ 6 months from last rituximab dose.

               -  No corticosteroids within two weeks prior to study, except for maintenance
                  therapy for a non-malignant disease. Maintenance therapy dose may not exceed 20
                  mg/day prednisone or equivalent.

               -  No prior radioimmunotherapy within 12 months of study entry.

          -  Age ≥ 18 years.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

          -  Measurable disease must be present either on physical examination or imaging studies.
             Non-measurable disease alone is not acceptable. Any tumor mass >1 cm is
             acceptable.Lesions that are considered non-measurable include the following:

               -  Bone lesions

               -  Ascites

               -  Pleural/pericardial effusion

               -  Lymphangitis cutis/pulmonis

               -  Bone marrow

          -  No known Central Nervous System (CNS) involvement by lymphoma.

          -  No known Human Immunodeficiency Virus (HIV) infection.

          -  Non-pregnant and non-nursing.

          -  Patients with a "currently active" second malignancy, other than non-melanoma skin
             cancers, are not eligible.

          -  Patients with a recent history (within 3 months of study entry) of Deep Vein
             Thrombosis/Pulmonary Embolism (DVT/PE) are not eligible.

          -  Required Initial Laboratory Values:

               -  Absolute Neutrophil Count (ANC) ≥ 1000/µL

               -  Platelet count ≥ 75,000/µL

               -  Creatinine < 1.5 x Upper Limit of Normal (ULN) unless attributed to lymphoma or
                  calculated clearance > 50 mL/min (patients on dialysis are not eligible)

               -  Total Bilirubin ≤ 2 x ULN unless attributed to lymphoma or Gilbert's disease