Lymphoma, Non-Hodgkin Clinical Trial
Official title:
A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma
The purpose of this study is to determine the effectiveness of six cycles of concurrent fludarabine and rituximab in patients with mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphoma (MZL) or CD5-, CD10-, CD20+ low-grade B cell lymphomas.
Objectives:
Primary
- To estimate the objective response rate.
Secondary
- To assess the safety.
- To describe the progression-free survival at one year.
- To examine the association between clonal cytogenetic abnormalities identified by FISH,
and the objective response rate as well as the progression-free survival at one year.
Target enrollment was 30 eligible patients. An 80% objective response rate at 1 month
restaging after 6 cycles was considered as evidence of activity in this patient population
while 60% was not considered activity. If at least 22 patients achieved objective response
the treatment would be considered promising. With 30 eligible patients, the probability of
observing this was 0.87 assuming a true rate of 80% and 0.09 assuming a true rate of 60%.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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