NCT00933335

Study of Safety and Efficacy of a Sequential Regimen Consisting of Three Cycles of Fludarabine Followed by Tositumomab and Iodine I 131 Tositumomab

Fludarabine Monophosphate Followed by Iodine I 131 Tositumomab for Untreated Low-grade and Follicular Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, single institution, phase II study of fludarabine monophosphate followed by Iodine I 131 Tositumomab for patients with previously untreated, advanced-stage (stage III or IV) low-grade, transformed low-grade and follicular non-Hodgkin's lymphoma. The primary objective of the study will be to evaluate the safety of this treatment combination and the secondary endpoint will be to evaluate efficacy.

Conditions

• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
BIOLOGICAL	Tositumomab and Iodine I 131 Tositumomab	Tositumomab and Iodine I 131 Tositumomab

Timeline

• Start date: 1998-08-01
• Primary completion: 2009-12-01
• Completion: 2010-08-01
• First posted: 2009-07-07
• Last updated: 2017-01-18
• Results posted: 2012-03-13