Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Rituximab

Immunomodulating Agents

Immunoconjugates

Antineoplastic Agents, Immunological

Immunologic Factors

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.

Clinical Trials

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.

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

OLYMPE - Prospective Cohort Study on the Management of Patients With Relapsed Follicular Lymphoma

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.

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.

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.

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

After study induction period (three visits) participants entered into either of two periods: 1. period of maintenance with MabThera followed by observation or 2. period of observation/maintenance without MabThera, followed by maintenance with MabThera.

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.

Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.

Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment.

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.

After the first disease progression the participants received chemotherapy, immunotherapy, radio immunotherapy, stem cell transplantation, or radiation therapy for therapeutic management of the refractory/relapsed follicular non-Hodgkin's lymphoma. One participant could receive more than one type of treatment after the first study disease progression.

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.

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

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).

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 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.

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.

All participants who received MabThera treatment before the first disease progression were reported.

The FACT-G with Lymphoma-Specific Additional Concerns Subscale (Lym) total score was calculated by adding the score obtained on the FACT-G (physical well-being, scored 0-28; social well-being, scored 0-28; functional well-being, scored 0-28; emotional well-being, scored 0-24), to the score obtained on the LYM subscale (15 items; responses to each item range from 0, "Not at all" to 4, "Very much"). Total score ranges from 0 to 168. Higher scores indicated a better participant-reported outcome/quality of life over the past week when responding to the items.

Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported.

Hoffmann-La Roche

Safety population (all participants, except duplicate cases and participants without data available) included 255 participants, here data for 243 participants is reported as 12 participants data were not available (participants without available follow-up for adverse effects).

Participants with histologically confirmed, refractory/relapsed 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

Participants with histologically confirmed, refractory/relapsed CD2 0-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.

Age, Continuous

Sex: Female, Male

Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.

Medical Communications

Pluri-disciplinary consultation meeting

Only the physician in charge of the participants

Discussion between physicians

Punctual consultation of an external physician

Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = participants who were evaluable for this outcome measure.

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

Complete response

Complete response not confirmed

Partial response >=50%

Partial response <50%

Stability

Progression

Participants with histologically confirmed, refractory/relapsed 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.

Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed (N)=number of participants evaluable for this outcome measure.

Percentage of Participants With Last Induction Treatment Response

Number of disease progressions: 0

Number of disease progressions: 1

Number of disease progressions: 2

Number of disease progressions: 3

Number of disease progressions: 4

Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.

Without MabThera

Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.

MabThera as Maintenance Therapy

Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those participants who entered in maintenance/observation after the first induction and before the first disease progression over the study.

Percentage of Participants With Number of Disease Progressions

Tumor burden: Data not available (n=32, 38)

Tumor burden: High (n=32, 38)

Tumor burden: Low (n=32, 38)

GELF criteria: at least 3 nodal sites (n=32, 38)

GELF criteria: Any nodal/extra-nodal mass(n=32,38)

GELF criteria: B symptoms (n=32, 38)

GELF criteria: Splenomegaly (n=32, 38)

GELF criteria: Pleural/ascites effusion (n=32, 38)

GELF criteria: Cytopenia (n=32, 38)

GELF criteria: None (n=32, 38)

GELF criteria: Not available (n=32, 38)

Ann-Arbor stage I (n=35, 39)

Ann-Arbor stage II (n=35, 39)

Ann-Arbor stage III (n=35, 39)

Ann-Arbor stage IV (n=35, 39)

Ann-Arbor stage data not available (n=35, 39)

Ann-Arbor stage not assessable (n=35, 39)

Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period. n=number of evaluable participant for each disease characteristics.

Percentage of Participants With Disease Characteristics at First Study Disease Progression

Progression Free Survival (PFS)

Time to Next Treatment

Overall Survival (OS)

At least one cycle of MabThera

All cycles with MabThera (monotherapy/combination)

At least one cycle of MabThera as monotherapy

All cycles with MabThera as monotherapy

At least one cycle of MabThera in combination

All cycles with MabThera in combination

Participants with histologically confirmed, refractory/relapsed 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. Participants who received MabThera treatment over the first study induction period was reported.

Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received MabThera maintenance therapy after the first study induction was reported.

All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.

Number of Participants Who Used MabThera

Chemotherapy plus MabThera

MabThera as monotherapy

Stem Cells Transplantation

Radio-immunotherapy

Chemotherapy alone

Radiation therapy

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

Regimen including fludarabine

Regimen including aracytine - platinum salts

CHOP-like

Regimen including ifosfamide - etoposide

Other chemotherapy

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

Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those who entered in maintenance/observation after the first induction and before the first disease progression over the study.

Percentage of Participants With MabThera as Maintenance Therapy

Maintenance with MabThera followed by observation

Observation followed by maintenance with MabThera

Only maintenance therapy

Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one MabThera infusion over the maintenance therapy period.

Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase

Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one infusion of MabThera and completed maintenance therapy with MabThera when associated with observation period.

Duration of MabThera Maintenance Therapy When Associated With Observation

Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed=all participants having had maintenance/observation period before the first study disease progression.

Percentage of Participants With Prescription of Injection Prophylaxis

Anti-pneumocystosis agent

Antiviral agents

Immunoglobulins

Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number participants analyzed= all participants having had maintenance/observation period before the first study disease progression and received infection prophylaxis treatment.

Percentage of Participants With Injection Prophylaxis Treatment

Only physician in charge of the participant

Punctual consultation with an external physician

Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period.

Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression

Missing

Chemotherapy

Immunotherapy

Radio immunotherapy

Stem cell transplantation

Number of Participants With Therapeutic Management After the First Study Disease Progression

Participants with histologically confirmed, refractory/relapsed 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. Participants who received treatment with MabThera over the first study induction period was reported.

Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.

All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome.

MabThera Regimen: Dose of MabThera

All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data.

MabThera Regimen: Infusion Duration

MabThera Regimen: Number of Cycles of MabThera

MabThera Regimen: Time Between Cycles

Treatment discontinuation: Yes (n=123)

Treatment discontinuation: No (n=123)

At least 1 dose modification: Yes (n=121)

At least 1 dose modification: No (n=121)

At least 1 duration modification: Yes (n=121)

At least 1 duration modification: No (n=121)

Number (No.) of dose modifications: 0 (n=121)

No. of dose modifications: 1 (n=121)

No. of dose modifications: 2 (n=121)

No. of dose modifications: 3 (n=121)

No. of dose modifications: 4 (n=121)

No. of dose modifications: 5 (n=121)

No. of dose modifications: 6 (n=121)

No. of infusion duration modifications: 0 (n=121)

No. of infusion duration modifications: 1 (n=121)

No. of infusion duration modifications: 2 (n=121)

No. of infusion duration modifications: 3 (n=121)

No of infusion duration modifications: 4 (n=121)

No. of infusion duration modifications: 5 (n=121)

No. of infusion duration modifications: 6 (n=121)

No. of infusion duration modifications: 7 (n=121)

No. of infusion duration modifications: 8 (n=121)

No. of infusion duration modifications: 9 (n=121)

All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one MabThera infusion over the maintenance therapy period. n=number of evaluable participants for each category.

Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase

Physical well-being (n=661)

Social well-being (n=660)

Emotional well-being (n=664)

Functional well-being (n=659)

Other worrying participants (n=662)

Global score (n=663)

All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. n=number of evaluable questionnaires for each category.

Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score

A day hospitalization

Short-lasting hospitalization

Short-stay hospitalization

During the induction period participants received either MabThera monotherapy, MabThera combination therapy (chemotherapy and at least one cycle with MabThera), or all cycles performed without MabThera administration.

First Induction

During maintenance therapy the participants received or did not received treatment with the MabThera.

Spots Global Cancer Trial Database for Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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