Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Intervention: epratuzumab; rituximab
Intervention description: Days 1, 8, 15, 22 and weeks 12, 20, 28, & 36: 360mg/sq m IV; Day 3, 8, 15, 22 and weeks 12, 20, 28, & 36: 375mg/sq m IV
Intervention MeSH terms: Rituximab; Epratuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II grade 1 follicular lymphoma; stage II grade 2 follicular lymphoma; stage II grade 3 follicular lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma

Summary:

      RATIONALE: Monoclonal antibodies, such as epratuzumab and 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. Giving
      epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin
      lymphoma.

      PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab
      works in treating patients with previously untreated follicular non-Hodgkin lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically* confirmed follicular non-Hodgkin lymphoma (NHL)

               -  Previously untreated disease

               -  WHO classification grade 1, 2, or 3a (> 15 centroblasts per high power field with
                  centrocytes present) that is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in
                  any unidimensional measurement) stage II disease NOTE: *Bone marrow biopsies as
                  the sole means of diagnosis are not acceptable, but they may be submitted in
                  conjunction with nodal biopsies; fine-needle aspirates are not acceptable for
                  diagnosis

          -  Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry

          -  Measurable disease by physical examination or imaging studies

               -  Any tumor mass > 1 cm is acceptable

               -  No nonmeasurable disease only, including any of the following:

                    -  Bone lesions

                    -  Ascites

                    -  Pleural/pericardial effusion

                    -  Lymphangitis cutis/pulmonis

                    -  Bone marrow (involvement by NHL should be noted)

          -  No known CNS involvement by lymphoma

          -  Required to participate in companion FDG-PET imaging study CALGB 580701

        PATIENT CHARACTERISTICS:

          -  ECOG performance status ≤ 2

          -  Absolute neutrophil count ≥ 1,000/μL

          -  Platelet count ≥ 50,000/μL

          -  Patients with HIV infection are eligible provided they meet the following criteria:

               -  No evidence of coinfection with hepatitis B or C

               -  CD4+ cell count ≥ 400/mm^3

               -  No evidence of resistant strains of HIV

               -  If not on anti-HIV therapy, HIV viral load < 10,000 copies HIV RNA/mL

               -  If on anti-HIV therapy, HIV viral load < 50 copies HIV RNA/mL

               -  No history of AIDS-defining conditions

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study therapy

          -  No known Human Anti-Chimeric Antibody (HACA)-positivity

        PRIOR CONCURRENT THERAPY:

          -  No prior therapy for NHL including chemotherapy, radiotherapy, or immunotherapy (e.g.,
             monoclonal antibody-based therapy)

          -  More than 2 weeks since prior corticosteroids except for maintenance therapy for
             non-malignant disease

          -  No concurrent dexamethasone or other steroids as antiemetics except for the following
             circumstances:

               -  Treatment of acute infusion reactions according to institutional procedures

          -  No concurrent hormonal therapy except steroids for adrenal failure OR hormones for
             non-disease-related conditions (e.g., insulin for diabetes)

          -  No other concurrent chemotherapeutic agents