NCT00117156

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Lymphoma, Non-Hodgkin
• MALT Lymphoma

Interventions

Type	Name	Description
DRUG	Fludarabine
DRUG	Rituximab

Timeline

• Start date: 2003-12-01
• Primary completion: 2008-10-01
• Completion: 2012-01-01
• First posted: 2005-07-04
• Last updated: 2016-08-01
• Results posted: 2014-10-06

Locations

4 sites across 1 country: United States