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

Completed

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: Rituximab

• Registration Number: NCT01684865
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-13
• Study Start: 2012-10-22
• Primary Completion: 2017-11-27
• Study Completion: 2017-11-27
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-28
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Hodgkin's Lymphoma Participants	Rituximab	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 Measures

Name	Time	Method
Percentage of Participants With Adverse Events	Baseline up to approximately 3 years

Secondary Outcome Measures

Name	Time	Method
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 Anti-Lymphoma Treatment (TTNLT)	Baseline up to institution of a new regimen (chemotherapy, radiotherapy or immunotherapy) (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)
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])

Trial Locations

Locations (1)

University Clinic of Hematology Skopje, Hospital Care Department; 🇲🇰 Skopje, Macedonia, The Former Yugoslav Republic of