Clinical trial NCT02316613: Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE)
Official title: OLYMPE - Prospective Cohort Study on the Management of Patients With Relapsed Follicular Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Follicular Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-12-15
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment of approximately 90 physicians who treat patients with follicular non-Hodgkin's lymphoma to actively participate in this observational study. Patients with relapsed or refractory follicular non-Hodgkin's lymphoma (World Health Organization grade 1-3) and requiring treatment are to be enrolled prospectively. Subgroup of interest: patients receiving MabThera® (rituximab) maintenance therapy.

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.


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)

Primary outcomes:
measure: Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase
timeFrame: Baseline
measure: Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase
timeFrame: Induction Phase: 18.7 months
measure: Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase
timeFrame: Induction Phase: 18.7 months
measure: Percentage of Participants With MabThera as Maintenance Therapy
timeFrame: Maintenance/observation Phase: 67.8 months
measure: Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase
timeFrame: Maintenance/observation Phase: 67.8 months
measure: Duration of MabThera Maintenance Therapy When Associated With Observation
timeFrame: Maintenance/observation Phase: 67.8 months
measure: Percentage of Participants With Prescription of Injection Prophylaxis
timeFrame: Maintenance/observation Phase: 67.8 months
measure: Percentage of Participants With Injection Prophylaxis Treatment
timeFrame: Maintenance/observation Phase: 67.8 months
measure: Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression
timeFrame: Up to 6 years
measure: Number of Participants With Therapeutic Management After the First Study Disease Progression
timeFrame: Up to 6 years
Secondary outcomes:
measure: Percentage of Participants With Last Induction Treatment Response
timeFrame: Induction Phase: 18.7 months
measure: Percentage of Participants With Number of Disease Progressions
timeFrame: Up to 6 years
measure: Percentage of Participants With Disease Characteristics at First Study Disease Progression
timeFrame: Up to 6 years
measure: Progression Free Survival (PFS)
timeFrame: Up to 6 years
measure: Time to Next Treatment
timeFrame: Up to 6 years
measure: Overall Survival (OS)
timeFrame: Up to 6 years
measure: Number of Participants Who Used MabThera
timeFrame: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
measure: MabThera Regimen: Dose of MabThera
timeFrame: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
measure: MabThera Regimen: Infusion Duration
timeFrame: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
measure: MabThera Regimen: Number of Cycles of MabThera
timeFrame: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
measure: MabThera Regimen: Time Between Cycles
timeFrame: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
measure: Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase
timeFrame: Maintenance phase : 67.8 months
measure: Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score
timeFrame: Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years])
measure: Number and Type of Hospitalization Associated With MabThera Perfusion
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Neuilly-sur-seine
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: