An Observational Study of First-Line Maintenance Rituximab (MabThera/Rituxan) in Participants With Follicular Non-Hodgkin's Lymphoma

Roche

Status: Completed

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: Rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT01684865

ML27993

Details and patient eligibility

About

This prospective observational study will evaluate the safety and efficacy of first-line rituximab maintenance therapy in participants with follicular non-Hodgkin's lymphoma. Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will be followed for a maximum of 3 years or until disease progression occurs.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological diagnosis of follicular non-Hodgkin's lymphoma
• Complete or partial response to first-line induction therapy with chemotherapy with rituximab
• Participants about to receive first-line rituximab maintenance treatment for follicular non-Hodgkin's lymphoma according to the local label

Exclusion criteria

• Pregnant or lactating women
• Receipt of an investigational drug within 30 days prior to initiation of observational drug
• Any medical or psychological alteration that, to criterion of the investigator, can jeopardize the capacity of the participant to grant informed consent
• Central nervous system involvement
• Hepatitis B or C virus infection or human immunodeficiency virus infection

Trial design

22 participants in 1 patient group

Non-Hodgkin's Lymphoma Participants

Description:

Participants initiated on rituximab maintenance therapy according to the standard of care and in line with the current summary of product characteristics will receive rituximab for maximum two years or until disease progression. Participants will be followed for one year after last dose of rituximab administered as maintenance.

Treatment:

Drug: Rituximab