Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma
I. To evaluate the safety of Pegfilgrastim in combination with rituximab in patients with
untreated or relapsed/refractory follicular, SLL or MZL.
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
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (ORR)
Two-sided 95% exact confidence intervals around the estimates will be calculated. Overall performance on study (weight loss, change in Karnofsky Scores) will be measured. Radiologic evaluation of the extent of disease following therapy will be used to assess response according to the standard World Health Organization (WHO) response criteria.
Up to 43 weeks
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|