An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Lymphoma

November 1, 2016 updated by: Hoffmann-La Roche

An Observational Phase IV Non Interventional Study in Patients With Advanced Follicular Lymphoma (III-IV) Evaluating the Safety of Maintenance Therapy With Rituximab After 8 Cycles of Rituximab in Combination With Chemotherapy as Induction Therapy in Previously Untreated Patients in Greece.

This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) in previously untreated patients with follicular lymphoma. Data will be collected for 3 years

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 115 27
      • Athens, Greece, 106 76
      • Patras, Greece, 265 00
      • Thessaloniki, Greece, 570 10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with stage III-IV follicular lymphoma

Description

Inclusion Criteria:

  • Adult patients, >/=18 years
  • Patients with previously untreated follicular lymphoma (stage III-IV) according to the approved summary of product characteristics (SPC)

Exclusion Criteria:

  • Contraindications to MabThera/Rituxan therapy according to the approved SPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years
Progression-free survival
Time Frame: 3 years
3 years
Event-free survival
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 29, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (Estimate)

May 31, 2012

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22236

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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