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

2016. január 28. frissítette: 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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Megfigyelő

Beiratkozás (Tényleges)

260

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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)

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
Beavatkozás / kezelés
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.
Drog: Rituximab
Más nevek:
  • MabThera®

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase
Időkeret: Baseline
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.
Baseline
Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase
Időkeret: Induction Phase: 18.7 months
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.
Induction Phase: 18.7 months
Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase
Időkeret: Induction Phase: 18.7 months
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.
Induction Phase: 18.7 months
Percentage of Participants With MabThera as Maintenance Therapy
Időkeret: Maintenance/observation Phase: 67.8 months
During the maintenance period participants received four weekly infusion of MabThera.
Maintenance/observation Phase: 67.8 months
Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase
Időkeret: Maintenance/observation Phase: 67.8 months
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.
Maintenance/observation Phase: 67.8 months
Duration of MabThera Maintenance Therapy When Associated With Observation
Időkeret: Maintenance/observation Phase: 67.8 months
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.
Maintenance/observation Phase: 67.8 months
Percentage of Participants With Prescription of Injection Prophylaxis
Időkeret: Maintenance/observation Phase: 67.8 months
Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.
Maintenance/observation Phase: 67.8 months
Percentage of Participants With Injection Prophylaxis Treatment
Időkeret: Maintenance/observation Phase: 67.8 months
Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment.
Maintenance/observation Phase: 67.8 months
Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression
Időkeret: Up to 6 years
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.
Up to 6 years
Number of Participants With Therapeutic Management After the First Study Disease Progression
Időkeret: Up to 6 years
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.
Up to 6 years

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Percentage of Participants With Last Induction Treatment Response
Időkeret: Induction Phase: 18.7 months
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.
Induction Phase: 18.7 months
Percentage of Participants With Number of Disease Progressions
Időkeret: Up to 6 years
Participants with at least one disease progression after the first study induction period were reported.
Up to 6 years
Percentage of Participants With Disease Characteristics at First Study Disease Progression
Időkeret: Up to 6 years
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).
Up to 6 years
Progression Free Survival (PFS)
Időkeret: Up to 6 years
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.
Up to 6 years
Time to Next Treatment
Időkeret: Up to 6 years
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.
Up to 6 years
Overall Survival (OS)
Időkeret: Up to 6 years
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.
Up to 6 years
Number of Participants Who Used MabThera
Időkeret: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
MabThera Regimen: Dose of MabThera
Időkeret: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
All participants who received MabThera treatment before the first disease progression were reported.
Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
MabThera Regimen: Infusion Duration
Időkeret: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
MabThera Regimen: Number of Cycles of MabThera
Időkeret: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
MabThera Regimen: Time Between Cycles
Időkeret: Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)
Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase
Időkeret: Maintenance phase : 67.8 months
Maintenance phase : 67.8 months
Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score
Időkeret: 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])
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.
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])
Number and Type of Hospitalization Associated With MabThera Perfusion
Időkeret: Up to 6 years
Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported.
Up to 6 years

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Hoffmann-La Roche

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2007. február 1.

Elsődleges befejezés (Tényleges)

2013. április 1.

A tanulmány befejezése (Tényleges)

2013. április 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2014. november 28.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2014. december 10.

Első közzététel (Becslés)

2014. december 15.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2016. február 25.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2016. január 28.

Utolsó ellenőrzés

2016. január 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • ML20248

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