drugset / Trial / NCT00521638

Study Evaluating TRU-015 in B-Cell Non-Hodgkin's Lymphoma

NCT00521638 ↗

NaSingle-groupOpen-labelTreatment

Summary

This is a study to evaluate the safety and efficacy of TRU-015 in treatment of B-cell Non-Hodgkin's Lymphoma (NHL). TRU-015 is also currently being evaluated in multiple clinical studies for the treatment of autoimmune disorders. Over 300 patients have received TRU-015 in these studies, and the data observed to date support its safety in patients with autoimmune disorders. Safety of an escalating dose of 4 weekly infusions of TRU-015 will be evaluated in subjects with relapsed NHL (see inclusion criteria for subtypes). Once a maximum tolerated dose (MTD) is confirmed or maximum dose to be studied is determined to be safe and well tolerated, an expanded cohort of subjects with relapsed follicular NHL will be evaluated for efficacy.

Timeline

Start
2007-09
Primary completion
2008-04
Completion
2008-04

Drugs

EvaluationDrugModalityDoseRoute
Subject TRU-015 Unknown 400 mg Intravenous
Subject TRU-015 Unknown 700 mg Intravenous
Subject TRU-015 Unknown 1000 mg Intravenous