Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma
- Evaluate the safety of rituximab and pegfilgrastim in patients with untreated or
relapsed/recurrent follicular lymphoma, small lymphocytic lymphoma, or marginal zone
- Evaluate the efficacy (including overall response rate and durability of objective
responses) of this regimen in these patients.
- Evaluate functional and phenotypic characteristics of host neutrophils.
- Evaluate changes of CD20 antigen expression and density of expression.
- Evaluate changes in serum tumor necrosis factor (TNF), interferon alpha, and free
OUTLINE: Patients receive rituximab IV once a week in weeks 1, 3, 5, 7, 15, 23, 31, and 39
and pegfilgrastim subcutaneously 3 days before receiving rituximab for a total of 8 doses.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study treatment
for correlative studies. Samples are analyzed for phenotype changes in neutrophils,
oxidative burst, and cytokine levels by flow cytometry and in vitro functional assays.
Patients with easily accessible lymphomatous lesions undergo excisional biopsy within 24
hours after completion of first dose of rituximab. Tissues are analyzed for infiltration of
neutrophils into tumor bed, changes in CD20 expression by immunohistochemistry, flow
cytometry, and western blot, and evidence of apoptosis.
After completion of study treatment, patients are followed every 4 months for 1 year, every
6 months for 2 years, and once at year 4.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate at weeks 11, 27, and 43
AT Weeks 11, 27, 43
AT Weeks 11, 27, 43
Francisco J. Hernandez-Ilizaturri, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|