drugset / Trial / NCT02423837

Bendamustine in Combination With Rituximab as a First-line Therapy Followed by Maintenance Therapy With Rituximab in Patients With Follicular Lymphoma

NCT02423837

NaSingle-groupOpen-labelTreatment

Summary

* To evaluate the efficacy of bendamustine in combination with rituximab as first line in patients with follicular lymphoma, 1-3A cytological type. * To evaluate the safety, tolerability and feasibility of bendamustine in combination with rituximab as 1st line in patients with follicular lymphoma, 1-3A cytological type. * To evaluate the impact of the regimen modification (bendamustine dose modification and/or extension of inter-cycle interval) into duration of complete and partial responses. * To evaluate estimated treatment duration, reasons of treatment withdrawal. * To evaluate the possibility of unification and standardization of therapy protocol BR (rituximab 375 mg/m2 on day 1 and bendamustine 90 mg/m2 on days 1-2). * To evaluate factors affecting overall and progression-free survival.

Timeline

Start
2013-12
Primary completion
2016-02
Completion
2021-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 90 mg/m2
Subject Rituximab Monoclonal antibody 375 mg/m2

Indications