Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants

Roche

Status: Completed

Conditions: Follicular Lymphoma

Treatments: Drug: Rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT02536664

ML22283

Details and patient eligibility

About

It is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of Rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (CD20)-positive follicular lymphoma (FL) in clinical practice.

Enrollment: 505 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years
• Previously untreated, relapsed or refractory CD 20-positive FL
• Responding to rituximab containing induction therapy (complete response [CR] or partial response [PR])
• To receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study)
• No ineligibility for rituximab

Exclusion criteria

Not Applicable (NA)

Trial design

505 participants in 2 patient groups

First-line Stratum

Description:

Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition.

Treatment:

Drug: Rituximab

Relapsed/Refractory Stratum

Description:

Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition.

Treatment:

Drug: Rituximab