Prospective, Non Interventional Study to Evaluate the Safety Profile of First- Line Rituximab Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma

Hoffmann-La Roche1 site in 1 country22 target enrollmentOctober 22, 2012

ConditionsNon-Hodgkin's Lymphoma

InterventionsRituximab

DrugsRituximab

Overview

Phase: Not Applicable
Intervention: Rituximab
Conditions: Non-Hodgkin's Lymphoma
Sponsor: Hoffmann-La Roche
Enrollment: 22
Locations: 1
Primary Endpoint: Percentage of Participants With Adverse Events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 22, 2012

End Date

November 27, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Rituximab

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events

Time Frame: Baseline up to approximately 3 years

Secondary Outcomes

Progression-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma(Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years]))
Time to Progression, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma(Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years]))
Time to Next Chemotherapy Treatment (TTNCT)(Baseline up to institution of a chemotherapy regimen or cytotoxic agent or radio-immunotherapy (up to approximately 3 years))
Time to Next Anti-Lymphoma Treatment (TTNLT)(Baseline up to institution of a new regimen (chemotherapy, radiotherapy or immunotherapy) (up to approximately 3 years))
Overall Survival(Baseline up to death (up to approximately 3 years))
Event-Free Survival, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma(Baseline up to disease progression or death (assessed at baseline and every 8 weeks during 2-year maintenance period and thereafter every 3 months during 1-year follow up period until disease progression or death [up to approximately 3 years]))
Percentage of Participants with Overall Response of Complete (CR/CRu) or Partial Response, as Assessed by Criteria for Evaluation of Response in Non-Hodgkin's Lymphoma(Baseline up to disease progression or death (assessed at baseline and every 8 weeks thereafter until disease progression or death [till the end of rituximab maintenance therapy, up to 2 years]))