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

Hoffmann-La Roche260 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

260

Conditions

Follicular Lymphoma

Interventions

RituximabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Unnamed facility

Neuilly-sur-Seine, France

Outcomes

Primary Outcomes

Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase

At study inclusion, the therapeutic management of participants was decided by either "pluri-disciplinary consultation meeting," "Only the physician in charge of the participant," "Discussion between physicians," or "Punctual consultation of an external physician." Percentage of participants with each of these modalities of therapeutic decision was reported.

Time frame: Baseline

Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase

Over the first treatment induction period, participants received following therapies for the treatment of refractory/relapsed follicular non-Hodgkin's lymphoma: chemotherapy combined with MabThera, chemotherapy alone, MabThera monotherapy, and stem cell transplantation, radio-immunotherapy, or radiation therapy combined with any other treatment. Study induction treatment phase consists total of three visits (one before the first cycle, one halfway through therapy and one after the last cycle to evaluate response). Induction treatment duration ranged between \<3 months to \>6 months. Each participants may received more than one therapy.

Time frame: Induction Phase: 18.7 months

Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase

Over the first study induction phase, participants received the following chemotherapy: regimen including fludarabine; regimen including aracytine - platinum salts; cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone (CHOP-like); cyclophosphamide/vincristine/prednisone (CVP); regimen including ifosfamide - etoposide; and other chemotherapy. One participant could receive more than one type of chemotherapy over the first treatment induction period.

Time frame: Induction Phase: 18.7 months

Percentage of Participants With MabThera as Maintenance Therapy

During the maintenance period participants received four weekly infusion of MabThera.

Time frame: Maintenance/observation Phase: 67.8 months

Data from ClinicalTrials.gov

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Duration of MabThera Maintenance Therapy When Associated With Observation

Duration of MabThera maintenance therapy was calculated from the end of induction period to the day before the first disease progression over the study (or to the date of last participant information if no disease progression until the end of the participant follow-up). Disease progression was based on the followings: Eastern Cooperative Oncology Group performance status; presence of B symptoms (fever 38°C in absence of infection for more than 8 days, night sweats, weight loss exceeding 10% in 6 months); evaluation of tumor mass (Groupe d'Etudes des Lymphomes Folliculaires criteria); number of nodal sites; number and location of extranodal sites; Ann-Arbor stage (I to IV); any histological documentation: type of biopsy (nodal, extranodal, bone marrow); histological type (progression of follicular non-Hodgkin's lymphomas or transformation); latest available hemoglobin, neutrophils, normal or leukemic lymphocytes, platelets, lactate dehydrogenase, and total gamma globulins level.

Time frame: Maintenance/observation Phase: 67.8 months

Secondary Outcomes

Percentage of Participants With Last Induction Treatment Response

Last Induction treatment response: the last response assessment over the first study induction treatment (complete response \[CR\]: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CR unconfirmed: CR along with regression in lymph node mass by more than \[\>\]75% in the sum of the products of greatest diameters \[SPD\]; Partial Response \[PR\]: greater than or equal to \[\>=\] 50% decrease in SPD of 6 largest dominant nodes or nodal masses; Progression was 1 of the following: 1) lymphadenopathy; 2) a \>=50% increase in previously noted or new appearance of hepato/splenomegaly; 3) \>=50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to Richter's syndrome; or 5) occurrence of cytopenia; Stable disease \[SD\]: absence of necessary criteria to achieve CR or PR, but no advancement to progression) was described at the end of first study induction.

Time frame: Induction Phase: 18.7 months

Percentage of Participants With Number of Disease Progressions

Participants with at least one disease progression after the first study induction period were reported.

Time frame: Up to 6 years

Percentage of Participants With Disease Characteristics at First Study Disease Progression

Disease characteristics included (tumor burden, measured from whole body computed tomography (CT) scan. Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria defined as parameters to initiate treatment in participants with untreated follicular lymphoma, grade 1,2,or 3A; having just one of the criteria justified treatment: 1. involvement of \>=3 nodal sites, each with diameter of \>=3 centimeter(cm); 2. any nodal/extranodal tumor mass with diameter of \>=7cm; 3. B symptoms (temperature \>=38 degrees celsius or night sweats or weight loss \>10% over past 6 months); 4. splenomegaly; 5. pleural effusion/peritoneal ascites; 6. cytopenia (leukocytes \<1×10\^9 and/or platelets \<100×10\^9/L. One participant could present with more than 1 GELF criterion. Ann Arbor staging was used as staging system for lymphomas (Stage I to IV); stage depended upon the place where malignant tissue was located (through biopsy, CT scan, or positron emission tomography) and on systemic symptoms due to lymphoma).

Time frame: Up to 6 years

Progression Free Survival (PFS)

The PFS was defined as the time from the date of first induction treatment over the study (first treatment administration of first cycle) to the date of first disease progression or participants death or date of lymphoma transformation diagnosis.

Time frame: Up to 6 years

Time to Next Treatment

Time to next treatment was calculated from the date of the end of first induction treatment administration over the study to the date of the start of next treatment after disease progression.

Time frame: Up to 6 years

Overall Survival (OS)

The overall survival was defined as the time from the date of first induction treatment administration over the study to the date of participants' death or early study withdrawal. OS was calculated using Kaplan-Meier method.

Time frame: Up to 6 years

Number of Participants Who Used MabThera