Study to Assess the Effect of Treatment With Bendamustine in Combination With Rituximab on QT Interval in Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)

Phase 3 Completed 54 enrolled Cephalon

NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to assess the effect of treatment with bendamustine on cardiac repolarization as reflected by the rate-corrected QT interval by the Fridericia method (QTcF).

Timeline

Start: 2010-02
Primary completion: 2012-06
Completion: 2012-06

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bendamustine	Small molecule	90 mg/m2	Intravenous
Subject	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous

Study to Assess the Effect of Treatment With Bendamustine in Combination With Rituximab on QT Interval in Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)

Summary

Timeline

Drugs

Indications