NCT02472756

A Study of Rituximab in Combination With Chemotherapy in Relapsed/Refractory Follicular Lymphoma

Relapsed/Refractory Follicular Lymphoma - Rituximab Therapy in Combination With Chemotherapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 4, open, prospective, non-interventional, multicenter trial for previously treated adult participants with relapsed/refractory follicular lymphoma (FL). Eligible participants with FL will receive 6-8 infusions of induction standard regimen of rituximab plus chemotherapy. Participants with complete or partial remission at end of induction will be assigned to maintenance therapy with rituximab once every 3 months for a maximum of 2 years or until relapse. The choice of the treatment regimen will be established on a per center basis, according to the standard in use in the country and in the center, and each center will use the same regimen through the study. Participants will be followed up for safety and efficacy evaluation in accordance with routine practice.

Conditions

• Lymphoma, Follicular

Interventions

Type	Name	Description
DRUG	Chemotherapy	The choice of the chemotherapy regimen will be established on a per center basis, according to the standard in use in the country and in the center. Protocol does not specify any particular chemotherapy regimen.
DRUG	Rituximab	The choice of the rituximab regimen will be established on a per center basis, according to the standard in use in the country and in the center. Protocol does not specify any particular chemotherapy regimen.

Timeline

• Start date: 2008-09-19
• Primary completion: 2014-05-30
• Completion: 2014-05-30
• First posted: 2015-06-16
• Last updated: 2017-08-01
• Results posted: 2016-08-12

Locations

6 sites across 1 country: Serbia