Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: rituximab
Intervention description: Given IV
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 545.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage III small lymphocytic lymphoma; stage III marginal zone lymphoma; stage IV small lymphocytic lymphoma; stage IV marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma

Summary:

      RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill
      them or deliver cancer-killing substances to them without harming normal cells. It is not yet
      known which rituximab regimen is more effective in treating indolent non-Hodgkin's lymphoma.

      PURPOSE: This randomized phase III trial is studying two different schedules of rituximab and
      comparing them to see how well they work in treating patients with low tumor burden indolent
      stage III non-Hodgkin's lymphoma or stage IV non-Hodgkin's lymphoma.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Histologically confirmed non-Hodgkin's lymphoma, including 1 of the following:

               -  Follicular grade 1 or 2

               -  Small lymphocytic

               -  Marginal zone (nodal)

               -  Marginal zone (splenic)

               -  Mucosa-associated lymphoid tissue (MALT)

          -  Stage III or IV disease

          -  Must meet the following criteria for low tumor burden:

               -  No nodal or extranodal mass at least 7 cm

               -  Less than 3 nodal masses greater than 3 cm in diameter

               -  No systemic symptoms or B symptoms

               -  No splenomegaly greater than 16 cm by a computed tomography (CT) scan

               -  No evidence of risk of compression of a vital organ (i.e., ureteral or epidural)

               -  No leukemic phase with greater than 5,000/mm^3 circulating lymphocytes

               -  No cytopenias, defined as any of the following:

                    -  Platelet count less than 100,000/mm^3

                    -  Hemoglobin less than 10 g/dL

                    -  Absolute neutrophil count less than 1,500/mm^3

          -  At least 1 objective measurable disease parameter

               -  Abnormal positron emission tomography (PET) scans will not constitute evaluable
                  disease unless verified by CT scan or other appropriate imaging

          -  Age: 18 and over

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Must meet the following criteria for labs:

               -  Hematopoietic

                    -  Absolute neutrophil count at least 1,500/mm^3*

                    -  Hemoglobin at least 10 g/dL*

                    -  Platelet count at least 100,000/mm^3*

                    -  NOTE: *Without growth factor and/or transfusion support

               -  Hepatic

                    -  Bilirubin no greater than 2 times upper limit of normal (ULN) OR direct
                       bilirubin normal for patients with Gilbert's Syndrome

                    -  The aspartate transaminase (AST) and alanine transaminase (ALT) ratio
                       (AST/ALT) no greater than 5 times ULN

                    -  Hepatitis B surface antigen negative

               -  Renal

                    -  Creatinine no greater than 2 times ULN

        EXCLUSION CRITERIA:

          -  Evidence of transformation to a large cell histology

          -  Pregnant or nursing. Fertile patients must use effective contraception

          -  HIV positive

          -  Uncontrolled active infection

          -  Other malignancy within the past 2 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

          -  Prior immunotherapy for lymphoma

          -  Prior chemotherapy for lymphoma

          -  Concurrent chemotherapy

          -  Prior radiotherapy for lymphoma

          -  Concurrent radiotherapy

          -  Concurrent radioimmunotherapy