- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02316613
Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE)
28 gennaio 2016 aggiornato da: Hoffmann-La Roche
OLYMPE - Prospective Cohort Study on the Management of Patients With Relapsed Follicular Lymphoma
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.
Panoramica dello studio
Tipo di studio
Osservativo
Iscrizione (Effettivo)
260
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Neuilly-sur-seine, Francia, 92521
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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.
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Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase
Lasso di tempo: Baseline
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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.
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Baseline
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Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase
Lasso di tempo: Induction Phase: 18.7 months
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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.
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Induction Phase: 18.7 months
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Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase
Lasso di tempo: Induction Phase: 18.7 months
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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.
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Induction Phase: 18.7 months
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Percentage of Participants With MabThera as Maintenance Therapy
Lasso di tempo: Maintenance/observation Phase: 67.8 months
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During the maintenance period participants received four weekly infusion of MabThera.
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Maintenance/observation Phase: 67.8 months
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Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase
Lasso di tempo: Maintenance/observation Phase: 67.8 months
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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.
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Maintenance/observation Phase: 67.8 months
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Duration of MabThera Maintenance Therapy When Associated With Observation
Lasso di tempo: Maintenance/observation Phase: 67.8 months
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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.
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Maintenance/observation Phase: 67.8 months
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Percentage of Participants With Prescription of Injection Prophylaxis
Lasso di tempo: Maintenance/observation Phase: 67.8 months
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Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.
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Maintenance/observation Phase: 67.8 months
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Percentage of Participants With Injection Prophylaxis Treatment
Lasso di tempo: Maintenance/observation Phase: 67.8 months
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Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis.
One participant could receive more than one infection prophylaxis treatment.
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Maintenance/observation Phase: 67.8 months
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Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression
Lasso di tempo: Up to 6 years
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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.
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Up to 6 years
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Number of Participants With Therapeutic Management After the First Study Disease Progression
Lasso di tempo: Up to 6 years
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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.
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Up to 6 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Participants With Last Induction Treatment Response
Lasso di tempo: Induction Phase: 18.7 months
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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.
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Induction Phase: 18.7 months
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Percentage of Participants With Number of Disease Progressions
Lasso di tempo: Up to 6 years
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Participants with at least one disease progression after the first study induction period were reported.
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Up to 6 years
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Percentage of Participants With Disease Characteristics at First Study Disease Progression
Lasso di tempo: Up to 6 years
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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).
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Up to 6 years
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Progression Free Survival (PFS)
Lasso di tempo: Up to 6 years
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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.
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Up to 6 years
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Time to Next Treatment
Lasso di tempo: Up to 6 years
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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.
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Up to 6 years
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Overall Survival (OS)
Lasso di tempo: Up to 6 years
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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.
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Up to 6 years
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Number of Participants Who Used MabThera
Lasso di tempo: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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MabThera Regimen: Dose of MabThera
Lasso di tempo: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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All participants who received MabThera treatment before the first disease progression were reported.
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Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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MabThera Regimen: Infusion Duration
Lasso di tempo: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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MabThera Regimen: Number of Cycles of MabThera
Lasso di tempo: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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MabThera Regimen: Time Between Cycles
Lasso di tempo: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
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Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase
Lasso di tempo: Maintenance phase : 67.8 months
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Maintenance phase : 67.8 months
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Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score
Lasso di tempo: 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])
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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.
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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])
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Number and Type of Hospitalization Associated With MabThera Perfusion
Lasso di tempo: Up to 6 years
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Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported.
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Up to 6 years
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2007
Completamento primario (Effettivo)
1 aprile 2013
Completamento dello studio (Effettivo)
1 aprile 2013
Date di iscrizione allo studio
Primo inviato
28 novembre 2014
Primo inviato che soddisfa i criteri di controllo qualità
10 dicembre 2014
Primo Inserito (Stima)
15 dicembre 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
25 febbraio 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 gennaio 2016
Ultimo verificato
1 gennaio 2016
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Linfoma non Hodgkin
- Linfoma
- Linfoma, follicolare
- Effetti fisiologici delle droghe
- Agenti antireumatici
- Agenti antineoplastici
- Fattori immunologici
- Agenti antineoplastici, immunologici
- Rituximab
Altri numeri di identificazione dello studio
- ML20248
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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