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

Sponsor
Hoffmann-La Roche
Study ID
NCT02316613
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Dec 15, 2014
Start date
Feb 28, 2007
Status verified
Jan 2016
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

Enrollment
260 participants (actual)

Arms

  • Arm: 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.

Primary Outcome Measure

Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase [ Time Frame: Baseline ]

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