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

NCT01684865 | Completed

• 1 other identifier: ML27993
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events

  Baseline up to approximately 3 years

Secondary Outcomes (7)

• 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)

Study Arms (1)

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.

Drug: Rituximab

Interventions

Rituximab DRUG

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

Also known as: MabThera®, Rituxan®

Non-Hodgkin's Lymphoma Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with follicular non-Hodgkin's lymphoma receiving first-line rituximab maintenance treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

University Clinic of Hematology Skopje, Hospital Care Department

Skopje, 1000, North Macedonia

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Study Start: October 22, 2012
• Primary Completion: November 27, 2017
• Study Completion: November 27, 2017
• Last Updated: December 29, 2017

Record last verified: 2017-12

Locations

NO (1)