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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684865
• Other study ID #: ML27993
• Status: Completed
• Phase: N/A
• First received: September 11, 2012
• Last updated: December 28, 2017
• Start date: October 22, 2012
• Est. completion date: November 27, 2017

Study information

• Verified date: December 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 27, 2017
• Est. primary completion date: November 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

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

Locations

Country	Name	City	State
Macedonia, The Former Yugoslav Republic of	University Clinic of Hematology Skopje, Hospital Care Department	Skopje

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Macedonia, The Former Yugoslav Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events		Baseline up to approximately 3 years
Secondary	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])
Secondary	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])
Secondary	Time to Next Anti-Lymphoma Treatment (TTNLT)		Baseline up to institution of a new regimen (chemotherapy, radiotherapy or immunotherapy) (up to approximately 3 years)
Secondary	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)
Secondary	Overall Survival		Baseline up to death (up to approximately 3 years)
Secondary	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])
Secondary	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])