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

Roche

Status: Completed

Conditions: Follicular Lymphoma

Treatments: Drug: Rituximab

Study type: Observational

Funder types: Industry

Identifiers

NCT02316613

ML20248

Details and patient eligibility

About

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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

260 participants in 1 patient group

All Participants

Description:

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.

Treatment:

Drug: Rituximab