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

28. januar 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

260

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Neuilly-sur-seine, Frankrig, 92521

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Medicin: Rituximab
Andre navne:
  • MabThera®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Last Induction Treatment Response
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2007

Primær færdiggørelse (Faktiske)

1. april 2013

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

28. november 2014

Først indsendt, der opfyldte QC-kriterier

10. december 2014

Først opslået (Skøn)

15. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML20248

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