A Study of Rituximab in Combination With Chemotherapy in Relapsed/Refractory Follicular Lymphoma (REFLECT 2)

Roche

Status: Completed

Conditions: Lymphoma, Follicular

Treatments: Drug: Chemotherapy; Drug: Rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT02472756

ML21872

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants diagnosed with FL and had already received one or more treatments

Exclusion criteria

• Participants who are not eligible for rituximab treatment according to summary of product characteristics (SmPC)

Trial design

41 participants in 1 patient group

Follicular Lymphoma Participants

Description:

Previously treated adult participants with relapsed/refractory FL will receive rituximab in combination with chemotherapy regimen. All treatments prescribed during the observation period will be at the treating physician's discretion. Participants will be followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.

Treatment:

Drug: Rituximab

Drug: Chemotherapy