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

Sponsor
Hoffmann-La Roche
Study ID
NCT01684865
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Due to observational nature of the study protocol does not specify any dosing schedule for rituximab.

Study Details

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.

Key Dates

Start date
Oct 22, 2012
Status verified
Dec 2017
Primary completion
Nov 27, 2017
Completion
Nov 27, 2017

Study Design

Enrollment
22 participants (actual)

Arms

  • Arm: Non-Hodgkin's Lymphoma Participants
    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.

Primary Outcome Measure

Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 3 years ]

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