Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicular Lymphoma, Small Lymphocytic Lymphoma, or Marginal Zone Lymphoma
Condition: Contiguous Stage II Grade 1 Follicular Lymphoma; Contiguous Stage II Grade 2 Follicular Lymphoma; Contiguous Stage II Grade 3 Follicular Lymphoma; Contiguous Stage II Marginal Zone Lymphoma; Contiguous Stage II Small Lymphocytic Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Grade 3 Follicular Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Splenic Marginal Zone Lymphoma; Stage I Grade 1 Follicular Lymphoma; Stage I Grade 2 Follicular Lymphoma; Stage I Grade 3 Follicular Lymphoma; Stage I Marginal Zone Lymphoma; Stage I Small Lymphocytic Lymphoma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Small Lymphocytic Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell; Recurrence
Intervention: pegfilgrastim; rituximab; flow cytometry; biopsy; immunohistochemistry staining method; western blotting
Intervention description: Given SC; Given IV; Correlative studies; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects and how well giving pegfilgrastim together with
      rituximab works in treating patients with untreated, relapsed, or refractory follicular
      lymphoma, small lymphocytic lymphoma (SLL), or marginal zone lymphoma (MZL).
      Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells
      found in bone marrow or peripheral blood and may help the immune system recover from the side
      effects of therapy. Monoclonal antibodies, such as rituximab, can block cancer growth in
      different ways. Some block the ability of cancer to grow and spread. Others find cancer cells
      and help kill them or tumor cancer-killing substances to them. Giving pegfilgrastim together
      with rituximab may kill more cancer cells
    

Eligibility criteria:

        Inclusion Criteria:

          -  Untreated or relapsed/refractory follicular, SLL or MZL (i.e. no limit to number of
             prior treatments as long as patients meet other study criteria)

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Measurable tumor size (at least one node measuring 4 cm^2 in bidimensional
             measurement)

          -  Expected survival of > 6 months

          -  Prior rituximab or other monoclonal immunotherapy permitted and eligible for rituximab
             monotherapy

          -  Full recovery from any significant toxicity associated with prior surgery, radiation
             therapy, chemotherapy, or immunotherapy

          -  Absolute neutrophil count > 1.0 x 10^9/L

          -  Platelets > 50 x 10^9/L

          -  Patients may receive erythropoietin growth factors to maintain adequate hemoglobin
             levels (>= 8.0 mg/dl)

          -  Creatinine < 1.5 x upper normal levels (UNL)

          -  Total bilirubin < 1.5 mg/dL (> 25.65 umol/L)

          -  Aspartate aminotransferase < 5 x UNL

          -  Alkaline phosphatase < 5 x UNL

          -  Informed consent approved in institutional review board (lRB)

          -  CD20+ B-cell lymphoma

        Exclusion Criteria:

          -  Prior history of human immunodeficiency virus (HIV)-positivity (routine HIV testing is
             required pretreatment)

          -  Serious non-malignant disease (e.g. active uncontrolled bacterial, viral, or fungal
             infections) or other conditions which, in the opinion of the principal investigator
             would compromise other protocol objectives

          -  Presence of central nervous system (CNS) lymphoma

          -  Chemotherapy within 4 weeks of the first scheduled study treatment

          -  Another primary malignancy (other than squamous or basal cell carcinoma of the skin or
             in-situ carcinoma of the cervix) for which the patient has not been disease-free for
             at least five years

          -  Major surgery, other than diagnostic surgery, within four weeks

          -  Patients with non-Hodgkin lymphoma (NHL) other than relapsed/refractory follicular,
             MZL or SLL

          -  Patients must not have a history of cardiac disease, defined as New York Heart
             Association Class II or greater or clinical evidence of congestive heart failure

          -  Concurrent use of other investigational agents

          -  Pregnant or breast feeding

          -  Subjects of reproductive potential who are not using adequate contraceptive
             precautions, in the judgment of the investigator

          -  Known hypersensitivity to any recombinant E coli-derived product, murine proteins, or
             any components of the study medications

          -  Concerns for the subject's compliance with the protocol

          -  Any premalignant myeloid condition or any malignancy with myeloid characteristics
             (e.g. myelodysplastic syndromes, acute or chronic myelogenous leukemia)

          -  Patient is currently enrolled in, or has not yet completed at least 30 days since
             ending another investigational device or drug trial