Spots Global Cancer Trial Database for Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma

Official Title: A Phase II Study of Fludarabine and Rituximab for the Treatment of Marginal Zone Non-Hodgkin's Lymphoma

Study ID: NCT00117156

Conditions

Lymphoma, Non-Hodgkin

MALT Lymphoma

Interventions

Fludarabine

Rituximab

Study Description

Brief Summary: 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.

Detailed Description: 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%.