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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)

NCT01073163 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2014-04-24

Study results available
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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).

Conditions

Interventions

DRUG

Bendamustine

Bendamustine at 90 mg/m\^2 IV on Days 1 and 2 of a 28-day cycle.

DRUG

Rituximab

Rituximab at 375 mg/m\^2 IV on Day 1 of a 28-day cycle.

Sponsors & Collaborators

  • Cephalon

    lead INDUSTRY

Principal Investigators

  • Sponsor's Medical Expert · Cephalon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States
  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01073163 on ClinicalTrials.gov