NCT01289223

A Trial to Investigate the Efficacy of Bendamustine in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Refractory to Rituximab.

A Randomised, Open Label, Multi-centre, Phase III Study to Investigate the Efficacy of Bendamustine Compared to Treatment of Physician's Choice in the Treatment of Subjects With Indolent Non-Hodgkin's Lymphoma (NHL) Refractory to Rituximab

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of bendamustine against treatment of physician's choice on progression-free survival in subjects with indolent B-cell NHL.

Detailed description

To test whether bendamustine will improve progression-free survival in subjects with indolent B-cell NHL that did not respond (stable disease or progressive disease) to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment compared to treatment of physican's choice.

Conditions

• Indolent B-cell NHL

Interventions

Type	Name	Description
DRUG	Bendamustine IV
OTHER	Treatment of Physicians Choice	Defined as any cancer specific therapy or best supportive care. Treatment should be given according to the label and based upon local institutional medical practice and clinical judgement.

Timeline

• Start date: 2011-02-01
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2011-02-03
• Last updated: 2018-09-04

Locations

3 sites across 2 countries: Australia, Slovakia