Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE)

NCT ID: NCT02316613

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2013-04-30

Brief Summary

This French national, multicenter, prospective, longitudinal, observational study will describe the treatment modalities of a cohort of patients with relapsed or refractory follicular non-Hodgkin's lymphoma, with evaluation of the cohort overall and according to the presence or not of MabThera® (rituximab) maintenance therapy. Actively participating physicians will enroll patients and collect therapeutic management data in a real-life setting up to 5 years.

Conditions

Follicular Lymphoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All Participants

Participants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. All participants received at least one cycle of rituximab (MabThera) during maintenance therapy or observation period.

Rituximab

Intervention Type: DRUG

Interventions

Rituximab

Intervention Type: DRUG

Other Intervention Names

MabThera®

Eligibility Criteria

Inclusion Criteria

• Adult patient (age >/= 18 years)
• Presenting with WHO grade 1-3, CD20-positive follicular non-Hodgkin's lymphoma, histologically confirmed at initial diagnosis
• In relapse (or refractory) after at least one line of treatment, regardless of the nature of previous treatments (chemotherapy and/or immunotherapy and/or radioimmunoconjugate therapy and/or radiation+chemotherapy) and for whom a decision was made to give salvage therapy
• Having received oral and written information about the study and having raised no objections to electronic capture and processing of his/her personal data

Exclusion Criteria

• Patient participating in a clinical trial evaluating a new, non-commercialized cancer treatment at the time of inclusion
• Follicular lymphoma presenting with a transformation to diffuse large cell non-Hodgkin's lymphoma
• First line treatment with radiotherapy alone
• Initial abstention from treatment (decision to not treat the progression at the time of inclusion in the OLYMPE study)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Neuilly-sur-Seine, , France

Countries

France

Other Identifiers

ML20248

Identifier Type: -

Identifier Source: org_study_id