Overview

This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Treatment rituximab
Sponsor Hoffmann-La Roche
Start date October 2012
End date July 2018
Trial size 22 participants
Trial identifier NCT01684865, ML27993

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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 2 years or until disease progression occurs.
rituximab MabThera, Rituxan
Due to observational nature of the study protocol does not specify any dosing schedule for rituximab.

Primary Outcomes

Measure
Number of Participants With Adverse Events
time frame: approximately up to 3 years

Secondary Outcomes

Measure
Time to Disease Progression (TTP) According to Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
time frame: approximately 3 years
Time to Next Anti-Lymphoma Treatment (TTNLT)
time frame: approximately 3 years
Time to Next Chemotherapy Treatment (TTNCT)
time frame: approximately 3 years
Overall Survival (OS)
time frame: approximately 3 years
Number of Participants With Response According to Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
time frame: approximately 3 years
Number of Participants Without an Event (Progression or Death) According to Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma
time frame: approximately 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 immuno deficiency infection

Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.