Recurrent Grade 1 Follicular Lymphoma Clinical Trial
Official title:
Rituximab and Dexamethasone in CD20 Positive Low Grade and Follicular Non-Hodgkin's Lymphoma
This phase II trial studies the side effects and how well giving rituximab and dexamethasone together works in treating patients with low-grade non-Hodgkin lymphoma (NHL). Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with dexamethasone may kill more cancer cells
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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