Rituximab and Dexamethasone in CD20 Positive Low Grade and Follicular Non-Hodgkin's Lymphoma
PRIMARY OBJECTIVES:
I. To estimate clinical response rate (RR) at 3 and 6 months. II. To estimate Grade 2-4
-infusion-related toxicity.
SECONDARY OBJECTIVES:
I. To evaluate laboratory parameters and correlate with clinical response including:
antibody dependent cell mediated cytotoxicity and effector cell phenotype analysis at
baseline, 4 weeks and three months.
II. To evaluate laboratory parameters and correlate with clinical response including:
soluble cluster of differentiation (CD)20 fragments or CD20-containing membrane fragments at
baseline, 4 weeks, and 3 months.
III. To evaluate laboratory parameters and correlate with clinical response including:
phenotype analysis of CD16 and CD32 on natural killer (NK) cells.
IV. To evaluate laboratory parameters and correlate with clinical response including:
rituximab pharmacokinetic studies at baseline, 4 weeks and 3 months.
OUTLINE:
Patients receive dexamethasone intravenously (IV) and rituximab IV once weekly. Treatment
continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 and 6 months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical RR
Response rates will be assessed separately among previously treated or refractory patients and those previously untreated.
Baseline, and at 3 and 6 months after completion of treatment
No
David Maloney
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
PSOC 2002
NCT00244855
May 2004
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |