Recurrent Small Lymphocytic Lymphoma Clinical Trial
Official title:
Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma
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
PRIMARY OBJECTIVES:
I. To evaluate the safety of Pegfilgrastim in combination with rituximab in patients with
untreated or relapsed/refractory follicular, SLL or MZL.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy (including overall response rate and durability of objective
responses) of Pegfilgrastim in combination with rituximab in patients with untreated or
relapsed/refractory follicular, SLL or MZL.
II. To evaluate functional and phenotypic characteristics of host neutrophils undergoing
treatment with Pegfilgrastim and rituximab.
III. To evaluate changes in cluster of differentiation (CD)20 antigen expression and density
of expression in patients receiving Pegfilgrastim and rituximab.
IV. To evaluate changes in serum levels of tumor necrosis factor (TNF), interferon alpha
(INFalpha) and free radical levels in patients undergoing treatment with Pegfilgrastim and
rituximab.
OUTLINE:
Patients receive pegfilgrastim subcutaneously (SC) followed by rituximab intravenously (IV) 3
days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 months for 1 year,
every 6 months for 2 years, and then yearly for 1 year.
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