title: Clinical Investigation of the Quality of Life Benefit of Using a Home Walking Exoskeleton for a Population of Multiple Sclerosis Patients With Gait Disorders.

acronym: EXHOMESEP

summary:
The goal of this clinical investigation is to evaluate the effectiveness of home use of a lightweight robotic lower limb exoskeleton as a walking aid device on quality of life in patients with multiple sclerosis with gait disorders.

Participants will wear an exoskeleton (Keeogo) for 8 weeks at home during the experimental phase. This phase is compared to an 8-week control phase at home with advice on regular physical activity adapted to their abilities.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Supportive Care

lead_sponsor: Pôle Saint Hélier

location_facility: Centre de rééducation Fonctionnelle Propara-Montpellier

location_facility: Hôpital Saint Philibert-Groupement des Hôpitaux de l'Institut Catholique de Lille

location_facility: Hospices Civils de Lyon - Hôpital Henry Gabrielle


title: A Multicenter, Interventional, Open-label Study to Monitor the Evolution of Motor Function in SMA Type II Adults Patients Treated With SPINRAZA®

acronym: SMAII

summary: SPINRAZA® (Nusinersen) is the first intrathecal administered drug which was approved by the FDA to treat SMA children and adults (2016). The aim is to monitor the evolution of the Motor Function Measure-32 for SMA type II adult patients treated with SPINRAZA® (Nusinersen).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Other

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Lyon
CHU de Nice
CHU de Toulouse
APHP
CHRU de Lille
CHU de Montpellier
Hopital de la Timone - APHM

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy With 177Lu-edotreotide Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

acronym: LEVEL

summary: LEVEL trial aims to demonstrate the higher efficacy of 177Lu-edotreotide over everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy. It is hypothesized that 177Lu-edotreotide may significantly increase the progression-free survival (PFS) compared to everolimus in lung and thymic carcinoids.

status: Recruiting

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

ipd_sharing_description:
Analyzed compiled results will be publicly available to support the conclusion from the study.

Individual data will be available upon reasonable request.

lead_sponsor: Grupo Espanol de Tumores Neuroendocrinos

collaborators:
ITM Oncologics GmbH
MFAR

location_country: Italy Spain France

location_facility: Centre Hospitalier Universitaire (CHU) Bordeux

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Digestive Disease Unit, Sant'Andrea University Hospital, ENETS Center of Excellence Rome, Rome, Italy.

location_facility: Hospital Universitario Ramón y Cajal, Madrid

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Complexo Hospitalario Universitario de Santiago de Compostela

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Department of Digestive Oncology - IUCT Rangueil-Larrey, CHU de Toulouse, Toulouse, France

location_facility: Unit of Nuclear Medicine, S. Maria Nuova Hospital-IRCCS of Reggio Emilia, Reggio Emilia, Italy

location_facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Irsì - Meldola

location_facility: Department of Digestive Oncology, CHU Saint Eloi, Montpellier, France/ ICM Cancer Institute at Montpellier

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Istituto Nazionale Tumori IRCCS - Napoli

location_facility: ICO Institut Català d'Oncologia L'Hospitalet

location_facility: Department of Nuclear Medicine, La Timone University Hospital, CERIMED, Aix-Marseille University, France

location_facility: Azienda Ospedaliera Spedali Civili Brescia

intervention_type: Drug

lead_sponsor_type: industriel


intervention_type: Procedure

acronym: STREAM

lead_sponsor: Boehringer Ingelheim

summary:
This study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a PCI facility. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.

The study is exploratory in nature and will examine this medical question. The efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated.

All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. All statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.

ReferenceType: derived

ReferenceCitation: Shavadia J, Welsh R, Gershlick A, Zheng Y, Huber K, Halvorsen S, Steg PG, Van de Werf F, Armstrong PW. Relationship Between Arterial Access and Outcomes in ST-Elevation Myocardial Infarction With a Pharmacoinvasive Versus Primary Percutaneous Coronary Intervention Strategy: Insights From the STrategic Reperfusion Early After Myocardial Infarction (STREAM) Study. J Am Heart Assoc. 2016 Jun 13;5(6):e003559. doi: 10.1161/JAHA.116.003559.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

license_normalized: no license

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (via pmcid lookup)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: LIRIAS (KU Leuven);PubMed Central;dspace.library.uu.nl;pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Bainey KR, Fresco C, Zheng Y, Halvorsen S, Carvalho A, Ostojic M, Goldstein P, Gershlick AH, Westerhout CM, Van de Werf F, Armstrong PW; STREAM Investigators. Implications of ischaemic area at risk and mode of reperfusion in ST-elevation myocardial infarction. Heart. 2016 Apr;102(7):527-33. doi: 10.1136/heartjnl-2015-308075. Epub 2016 Jan 18.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: British Medical Journal

ReferenceCitation: Shavadia J, Zheng Y, Dianati Maleki N, Huber K, Halvorsen S, Goldstein P, Gershlick AH, Wilcox R, Van de Werf F, Armstrong PW. Infarct Size, Shock, and Heart Failure: Does Reperfusion Strategy Matter in Early Presenting Patients With ST-Segment Elevation Myocardial Infarction? J Am Heart Assoc. 2015 Aug 24;4(8):e002049. doi: 10.1161/JAHA.115.002049.

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central;pdfs.semanticscholar.org

ReferenceCitation: Gershlick AH, Westerhout CM, Armstrong PW, Huber K, Halvorsen S, Steg PG, Ostojic M, Goldstein P, Carvalho AC, Van de Werf F, Wilcox RG. Impact of a pharmacoinvasive strategy when delays to primary PCI are prolonged. Heart. 2015 May;101(9):692-8. doi: 10.1136/heartjnl-2014-306686. Epub 2015 Feb 17.

ReferenceCitation: Sinnaeve PR, Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Lambert Y, Danays T, Soulat L, Halvorsen S, Ortiz FR, Vandenberghe K, Regelin A, Bluhmki E, Bogaerts K, Van de Werf F; STREAM investigators. ST-segment-elevation myocardial infarction patients randomized to a pharmaco-invasive strategy or primary percutaneous coronary intervention: Strategic Reperfusion Early After Myocardial Infarction (STREAM) 1-year mortality follow-up. Circulation. 2014 Sep 30;130(14):1139-45. doi: 10.1161/CIRCULATIONAHA.114.009570. Epub 2014 Aug 26.

ReferenceCitation: Dianati Maleki N, Van de Werf F, Goldstein P, Adgey JA, Lambert Y, Sulimov V, Rosell-Ortiz F, Gershlick AH, Zheng Y, Westerhout CM, Armstrong PW. Aborted myocardial infarction in ST-elevation myocardial infarction: insights from the STrategic Reperfusion Early After Myocardial infarction trial. Heart. 2014 Oct;100(19):1543-9. doi: 10.1136/heartjnl-2014-306023. Epub 2014 Jun 10.

ReferenceCitation: Armstrong PW, Gershlick AH, Goldstein P, Wilcox R, Danays T, Lambert Y, Sulimov V, Rosell Ortiz F, Ostojic M, Welsh RC, Carvalho AC, Nanas J, Arntz HR, Halvorsen S, Huber K, Grajek S, Fresco C, Bluhmki E, Regelin A, Vandenberghe K, Bogaerts K, Van de Werf F; STREAM Investigative Team. Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction. N Engl J Med. 2013 Apr 11;368(15):1379-87. doi: 10.1056/NEJMoa1301092. Epub 2013 Mar 10.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Armstrong PW, Gershlick A, Goldstein P, Wilcox R, Danays T, Bluhmki E, Van de Werf F; STREAM Steering Committee. The Strategic Reperfusion Early After Myocardial Infarction (STREAM) study. Am Heart J. 2010 Jul;160(1):30-35.e1. doi: 10.1016/j.ahj.2010.04.007.

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location_facility: 1123.28.3317B Boehringer Ingelheim Investigational Site

location_facility: 1123.28.70008 Boehringer Ingelheim Investigational Site

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location_facility: 1123.28.44620 Boehringer Ingelheim Investigational Site

location_facility: 1123.28.70007 Boehringer Ingelheim Investigational Site

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location_facility: 1123.28.55017 Boehringer Ingelheim Investigational Site

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location_facility: 1123.28.3387A Boehringer Ingelheim Investigational Site

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location_facility: 1123.28.3355B Boehringer Ingelheim Investigational Site

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status: Completed

title: STREAM (Strategic Reperfusion Early After Myocardial Infarction). Comparison of the Efficacy and Safety of a Strategy of Early Fibrinolytic Treatment With Tenecteplase and Additional Antiplatelet and Antithrombin Therapy Followed by Catheterisation Within 6-24 Hours or Rescue Coronary Intervention Versus a Strategy of Standard Primary PCI in Patients With Acute Myocardial Infarction Within 3 Hours of Onset of Symptoms

type: EudraCT Number

source: euctr

study_completion_date_type: Actual

location_country:
Germany
Italy
Poland
Norway
United Kingdom
Brazil
Austria
Belgium
Spain
Greece
Chile
Peru
Canada
Serbia
Russian Federation
France


title: COVID-19 and Rare Skin Diseases. European Observational Study (Data Research) During an Epidemic

summary: This is a European observational cohort study (data research) involving multiple centres to look at the potential impact of COVID infection on patients with rare skin diseases examining factors such as comorbidity, protection factors, and clinical and/or therapeutic factors. The data collected may provide additional information on the situation of patients and, on a wider basis, provide useful data applicable to the general population.

status: Unknown status

study_type: Observational

time_perspective: Other

lead_sponsor: Imagine Institute

location_country: Germany Italy Lithuania Czechia France

location_facility: Städtisches Klinikum Dessau, Dessau Medical Center

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: University Hospital Brno - EB Centrum CR Dermatolog

location_facility: University Hospital of Erlangen - ZSEER - Zentrum für Seltene Erkrankungen Erlangen

location_facility: Hôpital Necker - Enfants malades (AP-HP)

status_simplified: Unknown


title: Assessment of Two Modes of Premedication in Surgery - PREMED Study

acronym: PREMED

summary:
The purpose of this study is to test the level of anxiety in patients, the day before surgery (late afternoon) and immediately prior to surgery in 3 parallel groups of patients.

one receiving placebo before going to sleep (before sleep), the day prior surgery and placebo when awakening (awakening), the day of surgery
one receiving zopiclone (7.5 mg) before sleep and placebo at awakening
one receiving placebo before sleep and alprazolam (0.5 mg)at awakening

double blind, randomized controlled study

ReferenceCitation: Beydon L, Rouxel A, Camut N, Schinkel N, Malinovsky JM, Aveline C, Marret E, Bildea A, Dupoiron D, Liu N, Daniel V, Darsonval A, Chretien JM, Rault L, Bruna J, Alberti C. Sedative premedication before surgery--A multicentre randomized study versus placebo. Anaesth Crit Care Pain Med. 2015 Jun;34(3):165-71. doi: 10.1016/j.accpm.2015.01.005. Epub 2015 May 23.

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Angers

location_facility: Dept of Anesthesia, Hôpital Maison Blanche

status_simplified: Completed


title: A Phase III Randomized Trial Evaluating the Tailored Versus the Systematic Use of Defunctioning Stoma After Total Mesorectal Excision for Rectal Cancer

summary:
GRECCAR 17 will be the first prospective and randomized trial to assess a tailored policy in the use of defunctioning stoma after TME according to the personalized risk of anastomotic leakage. The tailored use of defunctioning stoma after TME for rectal cancer should improve both the quality of life of patients and the anorectal function, without any impact on anastomotic leakage. Moreover, for the healthcare system, this new approach could be a cost-effective strategy, leading to a decrease in healthcare expenses.

The main objective is to compare the impact of tailored defunctioning stoma after TME for rectal cancer versus the systematic use of defunctioning stoma on the evolution of the specific Quality Of Life (QLQC30) during the 12 months after surgery.

lead_sponsor: University Hospital, Bordeaux

location_facility: APHP - Hôpital Beaujon - Service de Chirurgie Digestive

location_facility: Institut du Cancer de Montpellier - Service de Chirurgie Digestive

location_facility: APHP - Hôpital Saint-Louis - Service de Chirurgie Viscérale, Cancérologique et Endocrinienne

location_facility: Groupe Hospitalier Paris St. Joseph - Service de Chirurgie Digestive et Obésité

location_facility: APHM - Hôpital Nord - Service de Chirurgie Digestive

location_facility: GH Diaconesses Croix Saint-Simon - Service de Chirurgie Digestive

location_facility: CHU Grenoble Alpes - Service de Chirurgie Digestive

location_facility: APHP - Hôpital Bicêtre - Service de Chirurgie Générale et Digestive

location_facility: APHP - Hôpital Saint Antoine - Service de Chirurgie Digestive

location_facility: CHRU de Besançon - Service de Chirurgie Générale, Digestive et Cancérologique - Unité de Transplantation Hépatique

location_facility: CHU de Rennes - Service de Chirurgie Hépatobiliaire et Digestive

location_facility: CHRU de Nancy - Service de Chirugie Digestive, Hépatobiliaire, endocrinienne et Cancérologique

location_facility: Institut Gustave Roussy - Service de Chirurgie Viscérale Oncologique

location_facility: CHRU de Tours - Service de Chirurgie Digestive Oncologique et Colorectale

location_facility: APHP - HEGP- Service de Chirurgie Digestive

location_facility: Centre Oscar Lambret - Service de Chirurgie Digestive

location_facility: CHU Amiens-Picardie - Service de Chirurgie Digestive

location_facility: CHU de Clermont-Ferrand - Service de Chirurgie Digestive et Hépato-biliaire

location_facility: Clinique Tivoli Ducos - Service de Chirurgie Digestive

location_facility: CHU de Lille - Service de Chirurgie Générale et Digestive

location_facility: CHU de Toulouse - Service de Chirurgie Digestive

location_facility: Hospices Civils de Lyon - Sevice de Chirurgie Digestive

location_facility: Hôpital Européen de Marseille - Service de Chirurgie Digestive

location_facility: CHU de Bordeaux - Service de Chirurgie Digestive et Endocrinienne - Unité Colorectale

location_facility: CHRU de Strasbourg - Service de Chirurgie Générale et

location_facility: APHM - Hôpital La Timone - Service de Chirurgie Digestive et Générale

location_facility: Institut Paoli Calmette - Service de Chirurgie Digestive

location_facility: CHU de Rouen - Service de Chirugie Digestive

appel_a_projets: PHRCK

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

titre: GRECCAR17-Essai randomisé de phase III évaluant l'utilisation sélective versus systématique de la stomie de dérivation après exérèse totale du mesorectum pour cancer du rectum

discipline_principale: cancer

nom_porteur: DENOST

prenom_porteur: Quentin


title: French, Prospective, Post-marketing Study to Describe the Use, Detection Performance and Safety Profile of Infracyanine® (Indocyanine Green) for Breast Cancer Patients Undergoing a Sentinel Lymph Node (SLN) Biopsy.

acronym: OASIS

summary:
This prospective, observational study will evaluate the patient-based sentinel lymph node detection rate when using the Infracyanine® (indocyanine green) dye technique in patients undergoing surgery for breast cancer.

The study will describe the demographic, clinical, and tumour characteristics of patients with breast cancer undergoing surgery.

The study will describe the characteristics of how the indocyanine green dye technique is used including the dose and volume of dye used, the number and type of injection sites used to give the dye, the equipment used to detect the dye and locate the sentinel lymph node, and whether indocyanine green is used on its own or with other dyes (blue dye and/or 99mTechnetium dye).

The study will evaluate the characteristics of sentinel lymph node biopsy procedures performed using indocyanine green dye including the number of biopsies performed, the time taken to detect the sentinel lymph node and perform the biopsy, and how many sentinel lymph nodes are detected using indocyanine green dye, blue dye, and 99mTechnetium dye.

The study will also assess the safety of using indocyanine green dye for 6 weeks following surgery.

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Vermersch C, Raia-Barjat T, Chapelle C, Lima S, Chauleur C. Randomized comparison between indocyanine green fluorescence plus 99mtechnetium and 99mtechnetium alone methods for sentinel lymph node biopsy in breast cancer. Sci Rep. 2019 May 6;9(1):6943. doi: 10.1038/s41598-019-43473-3.

ReferenceCitation: Guo J, Yang H, Wang S, Cao Y, Liu M, Xie F, Liu P, Zhou B, Tong F, Cheng L, Liu H, Wang S. Comparison of sentinel lymph node biopsy guided by indocyanine green, blue dye, and their combination in breast cancer patients: a prospective cohort study. World J Surg Oncol. 2017 Nov 2;15(1):196. doi: 10.1186/s12957-017-1264-7.

ReferenceCitation: Kitai T, Inomoto T, Miwa M, Shikayama T. Fluorescence navigation with indocyanine green for detecting sentinel lymph nodes in breast cancer. Breast Cancer. 2005;12(3):211-5. doi: 10.2325/jbcs.12.211.

ReferenceCitation: Sugie T, Kinoshita T, Masuda N, Sawada T, Yamauchi A, Kuroi K, Taguchi T, Bando H, Yamashiro H, Lee T, Shinkura N, Kato H, Ikeda T, Yoshimura K, Ueyama H, Toi M. Evaluation of the Clinical Utility of the ICG Fluorescence Method Compared with the Radioisotope Method for Sentinel Lymph Node Biopsy in Breast Cancer. Ann Surg Oncol. 2016 Jan;23(1):44-50. doi: 10.1245/s10434-015-4809-4. Epub 2015 Aug 15.

lead_sponsor: BTG International Inc.

sponsor_collaborators:
BTG International Inc.
Iqvia Pty Ltd

location_facility:
Institut de Cancérologie de Lorraine
Institut Bergonié
CHU de Saint-Etienne
Hôpital Européen Georges-Pompidou Paris
CHU de Lille
CH Annecy-Genevois


title: Interventional, Open-label Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care

summary: To determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in primary care

status: Terminated

design_allocation: Non-Randomized

lead_sponsor: H. Lundbeck A/S

location_country:
Germany
Spain
United Kingdom
France


title: Prospective , Multicentric, Randomized Phase II Study, Evaluating the Role of Cranial Radiotherapy or Intensive Chemotherapy With Hematopoietic Stem Cell Rescue After Conventional Chemotherapy for Primary Central Nervous System in Young Patients (< 60 y)

acronym: PRECIS

summary:
Purpose of the study :

To evaluate the antitumoral effect of two therapeutic procedures and to evaluate their respective toxicity on the CNS.

ReferenceCitation: Houillier C, Dureau S, Taillandier L, Houot R, Chinot O, Molucon-Chabrot C, Schmitt A, Gressin R, Choquet S, Damaj G, Peyrade F, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Al Jijakli A, Morel P, Waultier A, Paillassa J, Chauchet A, Gastinne T, Laadhari M, Plissonnier AS, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients Age 60 Years and Younger: Long-Term Results of the Randomized Phase II PRECIS Study. J Clin Oncol. 2022 Nov 10;40(32):3692-3698. doi: 10.1200/JCO.22.00491. Epub 2022 Jul 14.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Houillier C, Taillandier L, Dureau S, Lamy T, Laadhari M, Chinot O, Molucon-Chabrot C, Soubeyran P, Gressin R, Choquet S, Damaj G, Thyss A, Abraham J, Delwail V, Gyan E, Sanhes L, Cornillon J, Garidi R, Delmer A, Tanguy ML, Al Jijakli A, Morel P, Bourquard P, Moles MP, Chauchet A, Gastinne T, Constans JM, Langer A, Martin A, Moisson P, Lacomblez L, Martin-Duverneuil N, Delgadillo D, Turbiez I, Feuvret L, Cassoux N, Touitou V, Ricard D, Hoang-Xuan K, Soussain C; Intergroupe GOELAMS-ANOCEF and the LOC Network for CNS Lymphoma. Radiotherapy or Autologous Stem-Cell Transplantation for Primary CNS Lymphoma in Patients 60 Years of Age and Younger: Results of the Intergroup ANOCEF-GOELAMS Randomized Phase II PRECIS Study. J Clin Oncol. 2019 Apr 1;37(10):823-833. doi: 10.1200/JCO.18.00306. Epub 2019 Feb 20. Erratum In: J Clin Oncol. 2023 Aug 10;41(23):3961.

ipd_sharing: Undecided

lead_sponsor: Institut Curie

sponsor_collaborators:
Institut Curie
Ministry of Health, France
Hoffmann-La Roche
Amgen
Pierre Fabre Laboratories

location_facility:
Centre René Huguenin
Chu D'Angers
CHU Michalon
CHU Hôpital Bernard
GH Pitié-Salpétrière
CHU de Nimes
Cancérologie Hôpital Sud
Institut de Cancérologie
CHU de la Timone
CHG Saint Jean
Centre Antoine Lacassagne
Hôpital Pontchaillou
CHU de Besancon
Hôtel Dieu Nantes
Institut Bergonié
Centre Hospitalier Lens
Chu Reims
CHU de Limoges
CH de Saint-Quentin
CHU Hôtel Dieu
CHU Nancy - Hôpital Neurologique
Hôpital Bretonneau
CHR Argenteuil


acronym: BENEFIT

lead_sponsor: Centre Leon Berard

summary: The purpose of this study is to evaluate the efficacy and safety of BeEAM (bendamustine, etoposide, cytarabine and melphalan) regimen prior to autologous stem cell transplant for first and second chemosensitive relapses in patients with follicular lymphoma (World Health Organisation (WHO) grade 1, 2, 3a).

ReferenceCitation: A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. The Non-Hodgkin's Lymphoma Classification Project. Blood. 1997 Jun 1;89(11):3909-18.

ReferenceCitation: Armitage JO, Weisenburger DD. New approach to classifying non-Hodgkin's lymphomas: clinical features of the major histologic subtypes. Non-Hodgkin's Lymphoma Classification Project. J Clin Oncol. 1998 Aug;16(8):2780-95. doi: 10.1200/JCO.1998.16.8.2780.

ReferenceCitation: Harris NL, Jaffe ES, Diebold J, Flandrin G, Muller-Hermelink HK, Vardiman J, Lister TA, Bloomfield CD. World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: report of the Clinical Advisory Committee meeting-Airlie House, Virginia, November 1997. J Clin Oncol. 1999 Dec;17(12):3835-49. doi: 10.1200/JCO.1999.17.12.3835.

ReferenceCitation: Sabattini E, Bacci F, Sagramoso C, Pileri SA. WHO classification of tumours of haematopoietic and lymphoid tissues in 2008: an overview. Pathologica. 2010 Jun;102(3):83-7. No abstract available.

ReferenceCitation: Salles GA. Clinical features, prognosis and treatment of follicular lymphoma. Hematology Am Soc Hematol Educ Program. 2007:216-25. doi: 10.1182/asheducation-2007.1.216.

ReferenceCitation: Ott G, Katzenberger T, Lohr A, Kindelberger S, Rudiger T, Wilhelm M, Kalla J, Rosenwald A, Muller JG, Ott MM, Muller-Hermelink HK. Cytomorphologic, immunohistochemical, and cytogenetic profiles of follicular lymphoma: 2 types of follicular lymphoma grade 3. Blood. 2002 May 15;99(10):3806-12. doi: 10.1182/blood.v99.10.3806.

ReferenceCitation: Freedman AS. Biology and management of histologic transformation of indolent lymphoma. Hematology Am Soc Hematol Educ Program. 2005:314-20. doi: 10.1182/asheducation-2005.1.314.

ReferenceCitation: Montoto S, Fitzgibbon J. Transformation of indolent B-cell lymphomas. J Clin Oncol. 2011 May 10;29(14):1827-34. doi: 10.1200/JCO.2010.32.7577. Epub 2011 Apr 11.

ReferenceCitation: Federico M, Bellei M, Marcheselli L, Luminari S, Lopez-Guillermo A, Vitolo U, Pro B, Pileri S, Pulsoni A, Soubeyran P, Cortelazzo S, Martinelli G, Martelli M, Rigacci L, Arcaini L, Di Raimondo F, Merli F, Sabattini E, McLaughlin P, Solal-Celigny P. Follicular lymphoma international prognostic index 2: a new prognostic index for follicular lymphoma developed by the international follicular lymphoma prognostic factor project. J Clin Oncol. 2009 Sep 20;27(27):4555-62. doi: 10.1200/JCO.2008.21.3991. Epub 2009 Aug 3.

ReferenceCitation: Solal-Celigny P, Roy P, Colombat P, White J, Armitage JO, Arranz-Saez R, Au WY, Bellei M, Brice P, Caballero D, Coiffier B, Conde-Garcia E, Doyen C, Federico M, Fisher RI, Garcia-Conde JF, Guglielmi C, Hagenbeek A, Haioun C, LeBlanc M, Lister AT, Lopez-Guillermo A, McLaughlin P, Milpied N, Morel P, Mounier N, Proctor SJ, Rohatiner A, Smith P, Soubeyran P, Tilly H, Vitolo U, Zinzani PL, Zucca E, Montserrat E. Follicular lymphoma international prognostic index. Blood. 2004 Sep 1;104(5):1258-65. doi: 10.1182/blood-2003-12-4434. Epub 2004 May 4.

ReferenceCitation: Carreras J, Lopez-Guillermo A, Fox BC, Colomo L, Martinez A, Roncador G, Montserrat E, Campo E, Banham AH. High numbers of tumor-infiltrating FOXP3-positive regulatory T cells are associated with improved overall survival in follicular lymphoma. Blood. 2006 Nov 1;108(9):2957-64. doi: 10.1182/blood-2006-04-018218. Epub 2006 Jul 6.

ReferenceCitation: Dave SS, Wright G, Tan B, Rosenwald A, Gascoyne RD, Chan WC, Fisher RI, Braziel RM, Rimsza LM, Grogan TM, Miller TP, LeBlanc M, Greiner TC, Weisenburger DD, Lynch JC, Vose J, Armitage JO, Smeland EB, Kvaloy S, Holte H, Delabie J, Connors JM, Lansdorp PM, Ouyang Q, Lister TA, Davies AJ, Norton AJ, Muller-Hermelink HK, Ott G, Campo E, Montserrat E, Wilson WH, Jaffe ES, Simon R, Yang L, Powell J, Zhao H, Goldschmidt N, Chiorazzi M, Staudt LM. Prediction of survival in follicular lymphoma based on molecular features of tumor-infiltrating immune cells. N Engl J Med. 2004 Nov 18;351(21):2159-69. doi: 10.1056/NEJMoa041869.

ReferenceCitation: Glas AM, Kersten MJ, Delahaye LJ, Witteveen AT, Kibbelaar RE, Velds A, Wessels LF, Joosten P, Kerkhoven RM, Bernards R, van Krieken JH, Kluin PM, van't Veer LJ, de Jong D. Gene expression profiling in follicular lymphoma to assess clinical aggressiveness and to guide the choice of treatment. Blood. 2005 Jan 1;105(1):301-7. doi: 10.1182/blood-2004-06-2298. Epub 2004 Sep 2.

ReferenceCitation: Alvaro T, Lejeune M, Salvado MT, Lopez C, Jaen J, Bosch R, Pons LE. Immunohistochemical patterns of reactive microenvironment are associated with clinicobiologic behavior in follicular lymphoma patients. J Clin Oncol. 2006 Dec 1;24(34):5350-7. doi: 10.1200/JCO.2006.06.4766.

ReferenceCitation: Wahlin BE, Sander B, Christensson B, Kimby E. CD8+ T-cell content in diagnostic lymph nodes measured by flow cytometry is a predictor of survival in follicular lymphoma. Clin Cancer Res. 2007 Jan 15;13(2 Pt 1):388-97. doi: 10.1158/1078-0432.CCR-06-1734.

ReferenceCitation: Dreyling M, Ghielmini M, Marcus R, Salles G, Vitolo U; ESMO Guidelines Working Group. Newly diagnosed and relapsed follicular lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2011 Sep;22 Suppl 6:vi59-63. doi: 10.1093/annonc/mdr388. No abstract available.

ReferenceCitation: Sebban C, Mounier N, Brousse N, Belanger C, Brice P, Haioun C, Tilly H, Feugier P, Bouabdallah R, Doyen C, Salles G, Coiffier B. Standard chemotherapy with interferon compared with CHOP followed by high-dose therapy with autologous stem cell transplantation in untreated patients with advanced follicular lymphoma: the GELF-94 randomized study from the Groupe d'Etude des Lymphomes de l'Adulte (GELA). Blood. 2006 Oct 15;108(8):2540-4. doi: 10.1182/blood-2006-03-013193. Epub 2006 Jul 11.

ReferenceCitation: Fisher RI, LeBlanc M, Press OW, Maloney DG, Unger JM, Miller TP. New treatment options have changed the survival of patients with follicular lymphoma. J Clin Oncol. 2005 Nov 20;23(33):8447-52. doi: 10.1200/JCO.2005.03.1674. Epub 2005 Oct 17.

ReferenceCitation: Herold M, Haas A, Srock S, Neser S, Al-Ali KH, Neubauer A, Dolken G, Naumann R, Knauf W, Freund M, Rohrberg R, Hoffken K, Franke A, Ittel T, Kettner E, Haak U, Mey U, Klinkenstein C, Assmann M, von Grunhagen U; East German Study Group Hematology and Oncology Study. Rituximab added to first-line mitoxantrone, chlorambucil, and prednisolone chemotherapy followed by interferon maintenance prolongs survival in patients with advanced follicular lymphoma: an East German Study Group Hematology and Oncology Study. J Clin Oncol. 2007 May 20;25(15):1986-92. doi: 10.1200/JCO.2006.06.4618. Epub 2007 Apr 9.

ReferenceCitation: Hiddemann W, Kneba M, Dreyling M, Schmitz N, Lengfelder E, Schmits R, Reiser M, Metzner B, Harder H, Hegewisch-Becker S, Fischer T, Kropff M, Reis HE, Freund M, Wormann B, Fuchs R, Planker M, Schimke J, Eimermacher H, Trumper L, Aldaoud A, Parwaresch R, Unterhalt M. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2005 Dec 1;106(12):3725-32. doi: 10.1182/blood-2005-01-0016. Epub 2005 Aug 25.

ReferenceCitation: Marcus R, Imrie K, Belch A, Cunningham D, Flores E, Catalano J, Solal-Celigny P, Offner F, Walewski J, Raposo J, Jack A, Smith P. CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood. 2005 Feb 15;105(4):1417-23. doi: 10.1182/blood-2004-08-3175. Epub 2004 Oct 19.

ReferenceCitation: Marcus R, Imrie K, Solal-Celigny P, Catalano JV, Dmoszynska A, Raposo JC, Offner FC, Gomez-Codina J, Belch A, Cunningham D, Wassner-Fritsch E, Stein G. Phase III study of R-CVP compared with cyclophosphamide, vincristine, and prednisone alone in patients with previously untreated advanced follicular lymphoma. J Clin Oncol. 2008 Oct 1;26(28):4579-86. doi: 10.1200/JCO.2007.13.5376. Epub 2008 Jul 28.

ReferenceCitation: Salles G, Mounier N, de Guibert S, Morschhauser F, Doyen C, Rossi JF, Haioun C, Brice P, Mahe B, Bouabdallah R, Audhuy B, Ferme C, Dartigeas C, Feugier P, Sebban C, Xerri L, Foussard C. Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study. Blood. 2008 Dec 15;112(13):4824-31. doi: 10.1182/blood-2008-04-153189. Epub 2008 Sep 17.

ReferenceCitation: Salles G, Seymour JF, Offner F, Lopez-Guillermo A, Belada D, Xerri L, Feugier P, Bouabdallah R, Catalano JV, Brice P, Caballero D, Haioun C, Pedersen LM, Delmer A, Simpson D, Leppa S, Soubeyran P, Hagenbeek A, Casasnovas O, Intragumtornchai T, Ferme C, da Silva MG, Sebban C, Lister A, Estell JA, Milone G, Sonet A, Mendila M, Coiffier B, Tilly H. Rituximab maintenance for 2 years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet. 2011 Jan 1;377(9759):42-51. doi: 10.1016/S0140-6736(10)62175-7. Epub 2010 Dec 20. Erratum In: Lancet. 2011 Apr 2;377(9772):1154.

ReferenceCitation: Deconinck E, Foussard C, Milpied N, Bertrand P, Michenet P, Cornillet-LeFebvre P, Escoffre-Barbe M, Maisonneuve H, Delwail V, Gressin R, Legouffe E, Vilque JP, Desablens B, Jaubert J, Ramee JF, Jenabian A, Thyss A, Le Pourhiet-Le Mevel A, Travade P, Delepine R, Colombat P; GOELAMS. High-dose therapy followed by autologous purged stem-cell transplantation and doxorubicin-based chemotherapy in patients with advanced follicular lymphoma: a randomized multicenter study by GOELAMS. Blood. 2005 May 15;105(10):3817-23. doi: 10.1182/blood-2004-10-3920. Epub 2005 Feb 1.

ReferenceCitation: Gyan E, Foussard C, Bertrand P, Michenet P, Le Gouill S, Berthou C, Maisonneuve H, Delwail V, Gressin R, Quittet P, Vilque JP, Desablens B, Jaubert J, Ramee JF, Arakelyan N, Thyss A, Molucon-Chabrot C, Delepine R, Milpied N, Colombat P, Deconinck E; Groupe Ouest-Est des Leucemies et des Autres Maladies du Sang (GOELAMS). High-dose therapy followed by autologous purged stem cell transplantation and doxorubicin-based chemotherapy in patients with advanced follicular lymphoma: a randomized multicenter study by the GOELAMS with final results after a median follow-up of 9 years. Blood. 2009 Jan 29;113(5):995-1001. doi: 10.1182/blood-2008-05-160200. Epub 2008 Oct 27.

ReferenceCitation: Ladetto M, De Marco F, Benedetti F, Vitolo U, Patti C, Rambaldi A, Pulsoni A, Musso M, Liberati AM, Olivieri A, Gallamini A, Pogliani E, Rota Scalabrini D, Callea V, Di Raimondo F, Pavone V, Tucci A, Cortelazzo S, Levis A, Boccadoro M, Majolino I, Pileri A, Gianni AM, Passera R, Corradini P, Tarella C; Gruppo Italiano Trapianto di Midollo Osseo (GITMO); Intergruppo Italiano Linfomi (IIL). Prospective, multicenter randomized GITMO/IIL trial comparing intensive (R-HDS) versus conventional (CHOP-R) chemoimmunotherapy in high-risk follicular lymphoma at diagnosis: the superior disease control of R-HDS does not translate into an overall survival advantage. Blood. 2008 Apr 15;111(8):4004-13. doi: 10.1182/blood-2007-10-116749. Epub 2008 Jan 31.

ReferenceCitation: Lenz G, Dreyling M, Schiegnitz E, Forstpointner R, Wandt H, Freund M, Hess G, Truemper L, Diehl V, Kropff M, Kneba M, Schmitz N, Metzner B, Pfirrmann M, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. Myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission prolongs progression-free survival in follicular lymphoma: results of a prospective, randomized trial of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 1;104(9):2667-74. doi: 10.1182/blood-2004-03-0982. Epub 2004 Jul 6.

ReferenceCitation: Morschhauser F, Radford J, Van Hoof A, Vitolo U, Soubeyran P, Tilly H, Huijgens PC, Kolstad A, d'Amore F, Gonzalez Diaz M, Petrini M, Sebban C, Zinzani PL, van Oers MH, van Putten W, Bischof-Delaloye A, Rohatiner A, Salles G, Kuhlmann J, Hagenbeek A. Phase III trial of consolidation therapy with yttrium-90-ibritumomab tiuxetan compared with no additional therapy after first remission in advanced follicular lymphoma. J Clin Oncol. 2008 Nov 10;26(32):5156-64. doi: 10.1200/JCO.2008.17.2015. Epub 2008 Oct 14.

ReferenceCitation: van Oers MH, Van Glabbeke M, Giurgea L, Klasa R, Marcus RE, Wolf M, Kimby E, van t Veer M, Vranovsky A, Holte H, Hagenbeek A. Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study. J Clin Oncol. 2010 Jun 10;28(17):2853-8. doi: 10.1200/JCO.2009.26.5827. Epub 2010 May 3.

ReferenceCitation: Freedman AS, Neuberg D, Mauch P, Soiffer RJ, Anderson KC, Fisher DC, Schlossman R, Alyea EP, Takvorian T, Jallow H, Kuhlman C, Ritz J, Nadler LM, Gribben JG. Long-term follow-up of autologous bone marrow transplantation in patients with relapsed follicular lymphoma. Blood. 1999 Nov 15;94(10):3325-33.

ReferenceCitation: Kornacker M, Stumm J, Pott C, Dietrich S, Sussmilch S, Hensel M, Nickelsen M, Witzens-Harig M, Kneba M, Schmitz N, Ho AD, Dreger P. Characteristics of relapse after autologous stem-cell transplantation for follicular lymphoma: a long-term follow-up. Ann Oncol. 2009 Apr;20(4):722-8. doi: 10.1093/annonc/mdn691. Epub 2009 Jan 29.

ReferenceCitation: Montoto S, Canals C, Rohatiner AZ, Taghipour G, Sureda A, Schmitz N, Gisselbrecht C, Fouillard L, Milpied N, Haioun C, Slavin S, Conde E, Fruchart C, Ferrant A, Leblond V, Tilly H, Lister TA, Goldstone AH; EBMT Lymphoma Working Party. Long-term follow-up of high-dose treatment with autologous haematopoietic progenitor cell support in 693 patients with follicular lymphoma: an EBMT registry study. Leukemia. 2007 Nov;21(11):2324-31. doi: 10.1038/sj.leu.2404850. Epub 2007 Jul 19.

ReferenceCitation: Rohatiner AZ, Nadler L, Davies AJ, Apostolidis J, Neuberg D, Matthews J, Gribben JG, Mauch PM, Lister TA, Freedman AS. Myeloablative therapy with autologous bone marrow transplantation for follicular lymphoma at the time of second or subsequent remission: long-term follow-up. J Clin Oncol. 2007 Jun 20;25(18):2554-9. doi: 10.1200/JCO.2006.09.8327. Epub 2007 May 21.

ReferenceCitation: Vose JM, Bierman PJ, Loberiza FR, Lynch JC, Bociek GR, Weisenburger DD, Armitage JO. Long-term outcomes of autologous stem cell transplantation for follicular non-Hodgkin lymphoma: effect of histological grade and Follicular International Prognostic Index. Biol Blood Marrow Transplant. 2008 Jan;14(1):36-42. doi: 10.1016/j.bbmt.2007.06.016. Epub 2007 Dec 3.

ReferenceCitation: Schouten HC, Qian W, Kvaloy S, Porcellini A, Hagberg H, Johnsen HE, Doorduijn JK, Sydes MR, Kvalheim G. High-dose therapy improves progression-free survival and survival in relapsed follicular non-Hodgkin's lymphoma: results from the randomized European CUP trial. J Clin Oncol. 2003 Nov 1;21(21):3918-27. doi: 10.1200/JCO.2003.10.023. Epub 2003 Sep 29.

ReferenceCitation: Witzens-Harig M, Dreger P. Autologous transplant of follicular lymphoma in the era of rituximab. Leuk Lymphoma. 2010 Jun;51(6):967-74. doi: 10.3109/10428191003793341.

ReferenceCitation: Sebban C, Brice P, Delarue R, Haioun C, Souleau B, Mounier N, Brousse N, Feugier P, Tilly H, Solal-Celigny P, Coiffier B. Impact of rituximab and/or high-dose therapy with autotransplant at time of relapse in patients with follicular lymphoma: a GELA study. J Clin Oncol. 2008 Jul 20;26(21):3614-20. doi: 10.1200/JCO.2007.15.5358. Epub 2008 Jun 16.

ReferenceCitation: Le Gouill S, De Guibert S, Planche L, Brice P, Dupuis J, Cartron G, Van Hoof A, Casasnovas O, Gyan E, Tilly H, Fruchart C, Deconinck E, Fitoussi O, Gastaud L, Delwail V, Gabarre J, Gressin R, Blanc M, Foussard C, Salles G; GELA and GOELAMS. Impact of the use of autologous stem cell transplantation at first relapse both in naive and previously rituximab exposed follicular lymphoma patients treated in the GELA/GOELAMS FL2000 study. Haematologica. 2011 Aug;96(8):1128-35. doi: 10.3324/haematol.2010.030320. Epub 2011 Apr 12.

ReferenceCitation: Decaudin D, Mounier N, Tilly H, Ribrag V, Ghesquieres H, Bouabdallah K, Morschhauser F, Coiffier B, Le Gouill S, Bologna S, Delarue R, Huynh A, Bosly A, Briere J, Gisselbrecht C. (90)Y ibritumomab tiuxetan (Zevalin) combined with BEAM (Z -BEAM) conditioning regimen plus autologous stem cell transplantation in relapsed or refractory low-grade CD20-positive B-cell lymphoma. A GELA phase II prospective study. Clin Lymphoma Myeloma Leuk. 2011 Apr;11(2):212-8. doi: 10.1016/j.clml.2011.03.007. Epub 2011 Apr 9.

ReferenceCitation: Weigert O, Uysal A, Metzner B., et al.: Impact of autologous stem cell transplantation and/or rituximab on outcome of patients with relapsed follicular lymphoma - Retrospective analysis of 2 randomized trials of the German Low Grade Lymphoma Study Group (GLSG). ASH Annual Meeting Abstracts 112:2189, 2008 (abstr)

ReferenceCitation: Chow KU, Boehrer S, Napieralski S, Nowak D, Knau A, Hoelzer D, Mitrou PS, Weidmann E. In AML cell lines Ara-C combined with purine analogues is able to exert synergistic as well as antagonistic effects on proliferation, apoptosis and disruption of mitochondrial membrane potential. Leuk Lymphoma. 2003 Jan;44(1):165-73. doi: 10.1080/1042819021000054670.

ReferenceCitation: Leoni LM, Bailey B, Reifert J, Bendall HH, Zeller RW, Corbeil J, Elliott G, Niemeyer CC. Bendamustine (Treanda) displays a distinct pattern of cytotoxicity and unique mechanistic features compared with other alkylating agents. Clin Cancer Res. 2008 Jan 1;14(1):309-17. doi: 10.1158/1078-0432.CCR-07-1061.

ReferenceCitation: Fischer K, Stilgenbauer S, Schweighofer CD, et al.: Bendamustine in combination with rituximab (BR) for patients with relapsed chronic lymphocitic leukemia (CLL): a multicenter phase II trial of the German CLL study group. Blood 112, 2008 (abstr)

ReferenceCitation: Robinson KS, Williams ME, van der Jagt RH, Cohen P, Herst JA, Tulpule A, Schwartzberg LS, Lemieux B, Cheson BD. Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma. J Clin Oncol. 2008 Sep 20;26(27):4473-9. doi: 10.1200/JCO.2008.17.0001. Epub 2008 Jul 14.

ReferenceCitation: Rummel M, iederle N, aschmeyer G, et al.: Bendamustine plus rituximab is superior in respect of progression-free survival and CR rate when compared to CHOP plus rituximab as first-line treatment of patients with advanced follicular, indolent, and mantle cell lymphomas: Final results of a randomized phase III study of the StiL (Study Group Indolent Lymphomas, Germany). Lancet. 2013 Feb 19 (In press)

ReferenceCitation: Rummel MJ, Al-Batran SE, Kim SZ, Welslau M, Hecker R, Kofahl-Krause D, Josten KM, Durk H, Rost A, Neise M, von Grunhagen U, Chow KU, Hansmann ML, Hoelzer D, Mitrou PS. Bendamustine plus rituximab is effective and has a favorable toxicity profile in the treatment of mantle cell and low-grade non-Hodgkin's lymphoma. J Clin Oncol. 2005 May 20;23(15):3383-9. doi: 10.1200/JCO.2005.08.100.

ReferenceCitation: Friedberg JW, Cohen P, Chen L, Robinson KS, Forero-Torres A, La Casce AS, Fayad LE, Bessudo A, Camacho ES, Williams ME, van der Jagt RH, Oliver JW, Cheson BD. Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: results from a phase II multicenter, single-agent study. J Clin Oncol. 2008 Jan 10;26(2):204-10. doi: 10.1200/JCO.2007.12.5070. Erratum In: J Clin Oncol. 2008 Apr 10;26(11) 1911.

ReferenceCitation: Herold M, Schulze A, Niederwieser D, Franke A, Fricke HJ, Richter P, Freund M, Ismer B, Dachselt K, Boewer C, Schirmer V, Weniger J, Pasold R, Winkelmann C, Klinkenstein C, Schulze M, Arzberger H, Bremer K, Hahnfeld S, Schwarzer A, Muller C, Muller C; East German Study Group Hematology and Oncology (OSHO). Bendamustine, vincristine and prednisone (BOP) versus cyclophosphamide, vincristine and prednisone (COP) in advanced indolent non-Hodgkin's lymphoma and mantle cell lymphoma: results of a randomised phase III trial (OSHO# 19). J Cancer Res Clin Oncol. 2006 Feb;132(2):105-12. doi: 10.1007/s00432-005-0023-2. Epub 2005 Aug 9.

ReferenceCitation: Rasschaert M, Schrijvers D, Van den Brande J, Dyck J, Bosmans J, Merkle K, Vermorken JB. A phase I study of bendamustine hydrochloride administered once every 3 weeks in patients with solid tumors. Anticancer Drugs. 2007 Jun;18(5):587-95. doi: 10.1097/CAD.0b013e3280149eb1.

ReferenceCitation: Rasschaert M, Schrijvers D, Van den Brande J, Dyck J, Bosmans J, Merkle K, Vermorken JB. A phase I study of bendamustine hydrochloride administered day 1+2 every 3 weeks in patients with solid tumours. Br J Cancer. 2007 Jun 4;96(11):1692-8. doi: 10.1038/sj.bjc.6603776. Epub 2007 May 8.

ReferenceCitation: Visani G, Malerba L, Stefani PM, Capria S, Galieni P, Gaudio F, Specchia G, Meloni G, Gherlinzoni F, Giardini C, Falcioni S, Cuberli F, Gobbi M, Sarina B, Santoro A, Ferrara F, Rocchi M, Ocio EM, Caballero MD, Isidori A. BeEAM (bendamustine, etoposide, cytarabine, melphalan) before autologous stem cell transplantation is safe and effective for resistant/relapsed lymphoma patients. Blood. 2011 Sep 22;118(12):3419-25. doi: 10.1182/blood-2011-04-351924. Epub 2011 Aug 3.

ReferenceCitation: Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

ReferenceCitation: Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, Lister TA, Vose J, Grillo-Lopez A, Hagenbeek A, Cabanillas F, Klippensten D, Hiddemann W, Castellino R, Harris NL, Armitage JO, Carter W, Hoppe R, Canellos GP. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999 Apr;17(4):1244. doi: 10.1200/JCO.1999.17.4.1244. Erratum In: J Clin Oncol 2000 Jun;18(11):2351.

ReferenceCitation: Boellaard R, O'Doherty MJ, Weber WA, Mottaghy FM, Lonsdale MN, Stroobants SG, Oyen WJ, Kotzerke J, Hoekstra OS, Pruim J, Marsden PK, Tatsch K, Hoekstra CJ, Visser EP, Arends B, Verzijlbergen FJ, Zijlstra JM, Comans EF, Lammertsma AA, Paans AM, Willemsen AT, Beyer T, Bockisch A, Schaefer-Prokop C, Delbeke D, Baum RP, Chiti A, Krause BJ. FDG PET and PET/CT: EANM procedure guidelines for tumour PET imaging: version 1.0. Eur J Nucl Med Mol Imaging. 2010 Jan;37(1):181-200. doi: 10.1007/s00259-009-1297-4.

location_facility:
CHU de Rennes - Hôpital Pontchaillou
CHU de Nancy
Centre Léon Bérard
CHU Lyon Sud
CHU de Nantes Hôtel Dieu
CHU de Dijon - Hôpital Le Bocage
CHU Grenoble - Hôpital Michallon
CHU Henri Mondor
AP-HP Hôpital Saint-Louis
APHP Hôpital Necker
CHRU de Montpellier, Hôpital Saint-Eloi
CHRU de Lille Hôpital Claude Huriez
Centre Henri Becquerel

title: A Multicenter Phase II Study Evaluating BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) Prior to Autologous Stem Cell Transplant for First and Second Chemosensitive Relapses in Patients With Follicular Lymphoma


title: Study ¨PRECOCE Feasibility Study of Photovaporisation of Prostate With a Limitated Length of Catheterization of 3 Hours

acronym: PRECOCE

summary:
Benign hypertrophy of the prostate (BPH) is the most frequent pathology in the urinary tract of middle-aged men. In recent years, to enable BPH treatment with larger volumes and to reduce the risk of hemorrhage known to be associated to the transurethral resection of prostate treatment, transurethral photovaporisation of the prostate (PVP ) with the GreenLight (GL) XPS 180 W was developed. Therefore, the question arises to maximally reduce the length of catheterization to facilitate outpatient surgical management of prostate adenoma.

In the investigators study, the investigators propose to evaluate the failure rate of an early removal of the catheter 3 hours post-operative after a PVP procedure with GL 180 W/XPS in selected patients on general anesthesia or spinal anesthesia. To this end, the investigators realize a national multicenter prospective study including 300 patients. The effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours.

primary_purpose: Prevention

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: CHU Limoges -Urologie - Hôpital Dupuytren


title: Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey

acronym: MindCOVID

summary: The article presents a protocol of a cross-sectional study of mental health of pregnant women in relation to the COVID 19 pandemic. The primary aim is to compare differences in anxiety and depression scores of pregnant women between countries affected by the COVID-19 pandemic. The secondary aim is to assess demographic, economic, and social aspects affecting maternal anxiety and depression scores among pregnant women worldwide in the time of the COVID-19 pandemic. Finally, investigators will be able to compare differences in perception of the different aspects of the COVID-19 pandemic (social distancing, restrictions related to delivery) between countries and according to the epidemic status (number of infected patients, number of reported deaths). The comparisons will also be done according to COVID-19 status of the participants.

lead_sponsor: Żelazna Medical Centre, LLC

collaborators: Royal Prince Alfred Hospital, Sydney, Australia

collaborators: American University of Beirut Medical Center

collaborators: Centre of Postgraduate Medical Education

collaborators: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

collaborators: Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna", Madrid

location_country:
Germany
Italy
Poland
Albania
Israel
Hong Kong
Norway
Australia
Sweden
Lebanon
United States
Spain
Taiwan
Czechia
France

location_facility: Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz

location_facility: 11. Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna"


title: UVA Protection Factors of SPF 50 and 50+ Face Sunscreens

summary:
The goal of this observational study is to use the International Organization for Standardization (ISO) 24442:2011 in vivo method for assessment of the Ultraviolet A Protection Factor (UVAPF) of topical sunscreen products in healthy adults. The main question it aims to answer is to determine the degree of UVA-protection against UVA radiation.

An area of each subject's skin is exposed to UVA light without any protection and another (different) area is exposed after application of the sunscreen product under test. One further area is exposed after application of a reference UVA sunscreen formulation (S2), which is used to validate the procedure.

lead_sponsor: Cosmetique Active International

location_country: Romania Poland Brazil France

location_facility:
CIDP
Eurofins Dermscan Poland
Intertek
Eurofins Dermscan France
Allergisa
EVIC


title: Tolerance of Long Term Administration of Forlax® 10g in Elderly Ambulatory or Institutionalized Patients Suffering From Chronic Constipation. Single Blind Randomised Lactulose-controlled Study With Individual Expected Benefit.

summary: The main purpose of this study is to evaluate the tolerance of long term repeated doses of Forlax® 10g versus lactulose in elderly ambulatory or institutionalized patients, paying special attention to digestive and nutritional status.

lead_sponsor: Ipsen

location_facility: Hôpital Charles Nicolle - Service de Biochimie Médicale

location_facility: Hôpital Charles Nicolle - Service de Gastroentérologie et Nutrition

location_facility: Centre Hospitalier Sud Hôpital Xavier Arnozan


title: Validation d'Une Stratégie de Programme Transfusionnel Par Erythraphérèse basée Sur un Algorithme d'Aide à la Prescription Transfusionnelle Chez Les Patients Adultes Drépanocytaires

acronym: ALGODREP

summary:
The main objective of this study is to prove the superiority of a procedure which calculates the volume of RBCs to transfuse and the time between apheresis based on this algorithm, compared to the current procedure. The primary endpoint would be the number of patients with individually achieved objectives in terms of % HbS before each apheresis (which reflects the effectiveness of the previous apheresis) over a period of 12 months. The secondary objectives would be to compare the volume differences of transfused RBCs in both groups over a period of 12 months, the occurrence of clinical events and the satisfaction of patients and physicians.

The investigators hope that this study would improve the efficiency and the performance of apheresis in sickle cell patients. The investigators also hope to facilitate the organization of procedures with the flexibility that would allow the use of this algorithm.

ReferenceCitation: Quinn CT, Ahmad N. Clinical correlates of steady-state oxyhaemoglobin desaturation in children who have sickle cell disease. Br J Haematol. 2005 Oct;131(1):129-34. doi: 10.1111/j.1365-2141.2005.05738.x.

ReferenceCitation: Quinn CT, Sargent JW. Daytime steady-state haemoglobin desaturation is a risk factor for overt stroke in children with sickle cell anaemia. Br J Haematol. 2008 Feb;140(3):336-9. doi: 10.1111/j.1365-2141.2007.06927.x. Epub 2007 Nov 27.

ReferenceCitation: Setty BN, Stuart MJ, Dampier C, Brodecki D, Allen JL. Hypoxaemia in sickle cell disease: biomarker modulation and relevance to pathophysiology. Lancet. 2003 Nov 1;362(9394):1450-5. doi: 10.1016/S0140-6736(03)14689-2.

ReferenceCitation: Nahavandi M, Nichols JP, Hassan M, Gandjbakhche A, Kato GJ. Near-infrared spectra absorbance of blood from sickle cell patients and normal individuals. Hematology. 2009 Feb;14(1):46-8. doi: 10.1179/102453309X385133.

ReferenceCitation: Nahavandi M, Tavakkoli F, Hasan SP, Wyche MQ, Castro O. Cerebral oximetry in patients with sickle cell disease. Eur J Clin Invest. 2004 Feb;34(2):143-8. doi: 10.1111/j.1365-2362.2004.01307.x.

ReferenceCitation: Waltz X, Pichon A, Lemonne N, Mougenel D, Lalanne-Mistrih ML, Lamarre Y, Tarer V, Tressieres B, Etienne-Julan M, Hardy-Dessources MD, Hue O, Connes P. Normal muscle oxygen consumption and fatigability in sickle cell patients despite reduced microvascular oxygenation and hemorheological abnormalities. PLoS One. 2012;7(12):e52471. doi: 10.1371/journal.pone.0052471. Epub 2012 Dec 20.

ReferenceCitation: Waltz X, Pichon A, Mougenel D, Lemonne N, Lalanne-Mistrih ML, Sinnapah S, Tarer V, Tressieres B, Lamarre Y, Etienne-Julan M, Hue O, Hardy-Dessources MD, Connes P. Hemorheological alterations, decreased cerebral microvascular oxygenation and cerebral vasomotion compensation in sickle cell patients. Am J Hematol. 2012 Dec;87(12):1070-3. doi: 10.1002/ajh.23318. Epub 2012 Aug 22.

ReferenceCitation: Belcher JD, Chen C, Nguyen J, Milbauer L, Abdulla F, Alayash AI, Smith A, Nath KA, Hebbel RP, Vercellotti GM. Heme triggers TLR4 signaling leading to endothelial cell activation and vaso-occlusion in murine sickle cell disease. Blood. 2014 Jan 16;123(3):377-90. doi: 10.1182/blood-2013-04-495887. Epub 2013 Nov 25.

ReferenceCitation: Eltzschig HK, Carmeliet P. Hypoxia and inflammation. N Engl J Med. 2011 Feb 17;364(7):656-65. doi: 10.1056/NEJMra0910283. No abstract available.

ReferenceCitation: Eltzschig HK, Eckle T. Ischemia and reperfusion--from mechanism to translation. Nat Med. 2011 Nov 7;17(11):1391-401. doi: 10.1038/nm.2507.

ReferenceCitation: Lionnet F, Arlet JB, Bartolucci P, Habibi A, Ribeil JA, Stankovic K; groupe de recommandations et d'etude de la drepanocytose de l'adulte (GREDA). [Guidelines for management of adult sickle cell disease]. Rev Med Interne. 2009 Sep;30 Suppl 3:S162-223. doi: 10.1016/j.revmed.2009.07.001. Epub 2009 Aug 26. French.

ReferenceCitation: Adams RJ, McKie VC, Hsu L, Files B, Vichinsky E, Pegelow C, Abboud M, Gallagher D, Kutlar A, Nichols FT, Bonds DR, Brambilla D. Prevention of a first stroke by transfusions in children with sickle cell anemia and abnormal results on transcranial Doppler ultrasonography. N Engl J Med. 1998 Jul 2;339(1):5-11. doi: 10.1056/NEJM199807023390102.

ReferenceCitation: Adams RJ, Brambilla D; Optimizing Primary Stroke Prevention in Sickle Cell Anemia (STOP 2) Trial Investigators. Discontinuing prophylactic transfusions used to prevent stroke in sickle cell disease. N Engl J Med. 2005 Dec 29;353(26):2769-78. doi: 10.1056/NEJMoa050460.

ReferenceCitation: Abboud MR, Yim E, Musallam KM, Adams RJ; STOP II Study Investigators. Discontinuing prophylactic transfusions increases the risk of silent brain infarction in children with sickle cell disease: data from STOP II. Blood. 2011 Jul 28;118(4):894-8. doi: 10.1182/blood-2010-12-326298. Epub 2011 Jun 1.

ReferenceCitation: Gueguen A, Mahevas M, Nzouakou R, Hosseini H, Habibi A, Bachir D, Brugiere P, Lionnet F, Ribei JA, Godeau B, Girot R, Ibrahima V, Calvet D, Galacteros F, Bartolucci P. Sickle-cell disease stroke throughout life: a retrospective study in an adult referral center. Am J Hematol. 2014 Mar;89(3):267-72. doi: 10.1002/ajh.23625.

lead_sponsor: Etablissement Français du Sang

sponsor_collaborators:
Etablissement Français du Sang
Assistance Publique - Hôpitaux de Paris
Université Paris Est Créteil

location_country: Martinique France

location_facility:
EFS Rhône-Alpes-Auvergne
Hôpital Henri Mondor
CHU Kremlin Bicêtre
CHU de Martinique
Centre de Santé EFS

intervention_type: Device


title: A Randomized Phase II Study to Evaluate the Efficacy and Safety of Cetuximab in Metastatic Penile Carcinoma

acronym: PENILANE

summary: The purpose of this study is to evaluate the efficacy and safety of Cetuximab in metastatic penile carcinoma

status: Withdrawn

ReferenceCitation: Bleeker MC, Heideman DA, Snijders PJ, Horenblas S, Dillner J, Meijer CJ. Penile cancer: epidemiology, pathogenesis and prevention. World J Urol. 2009 Apr;27(2):141-50. doi: 10.1007/s00345-008-0302-z. Epub 2008 Jul 8.

ReferenceCitation: Barnholtz-Sloan JS, Maldonado JL, Pow-sang J, Giuliano AR. Incidence trends in primary malignant penile cancer. Urol Oncol. 2007 Sep-Oct;25(5):361-7. doi: 10.1016/j.urolonc.2006.08.029. Erratum In: Urol Oncol. 2008 Jan-Feb;26(1):112. Guiliano, Anna R [corrected to Giuliano, Anna R].

ReferenceCitation: Curado M.P., Edwards B., Shin H.R. et al. Cancer Incidence in Five continents. Sci Publ. 2007. 160:570-573.

ReferenceCitation: Calmon MF, Tasso Mota M, Vassallo J, Rahal P. Penile carcinoma: risk factors and molecular alterations. ScientificWorldJournal. 2011 Feb 3;11:269-82. doi: 10.1100/tsw.2011.24.

ReferenceCitation: Rigaud J., Avancès C., Camparo P. et al. Recommendations en onco-urologie 2010: Tumeurs malignes du penis. Progrès en oncologie. 2010. Suppl.4:279-289.

ReferenceCitation: Philippou P, Shabbir M, Malone P, Nigam R, Muneer A, Ralph DJ, Minhas S. Conservative surgery for squamous cell carcinoma of the penis: resection margins and long-term oncological control. J Urol. 2012 Sep;188(3):803-8. doi: 10.1016/j.juro.2012.05.012. Epub 2012 Jul 19.

ReferenceCitation: Smith Y, Hadway P, Biedrzycki O, Perry MJ, Corbishley C, Watkin NA. Reconstructive surgery for invasive squamous carcinoma of the glans penis. Eur Urol. 2007 Oct;52(4):1179-85. doi: 10.1016/j.eururo.2007.02.038. Epub 2007 Feb 20.

ReferenceCitation: Di Lorenzo G, Buonerba C, Federico P, Perdona S, Aieta M, Rescigno P, D'Aniello C, Puglia L, Petremolo A, Ferro M, Marinelli A, Palmieri G, Sonpavde G, Mirone V, De Placido S. Cisplatin and 5-fluorouracil in inoperable, stage IV squamous cell carcinoma of the penis. BJU Int. 2012 Dec;110(11 Pt B):E661-6. doi: 10.1111/j.1464-410X.2012.11453.x. Epub 2012 Sep 10.

ReferenceCitation: Haas GP, Blumenstein BA, Gagliano RG, Russell CA, Rivkin SE, Culkin DJ, Wolf M, Crawford ED. Cisplatin, methotrexate and bleomycin for the treatment of carcinoma of the penis: a Southwest Oncology Group study. J Urol. 1999 Jun;161(6):1823-5.

ReferenceCitation: Pagliaro LC, Williams DL, Daliani D, Williams MB, Osai W, Kincaid M, Wen S, Thall PF, Pettaway CA. Neoadjuvant paclitaxel, ifosfamide, and cisplatin chemotherapy for metastatic penile cancer: a phase II study. J Clin Oncol. 2010 Aug 20;28(24):3851-7. doi: 10.1200/JCO.2010.29.5477. Epub 2010 Jul 12.

ReferenceCitation: Lavens N, Gupta R, Wood LA. EGFR overexpression in squamous cell carcinoma of the penis. Curr Oncol. 2010 Feb;17(1):4-6. doi: 10.3747/co.v17i1.471. No abstract available.

ReferenceCitation: Andersson P, Kolaric A, Windahl T, Kirrander P, Soderkvist P, Karlsson MG. PIK3CA, HRAS and KRAS gene mutations in human penile cancer. J Urol. 2008 May;179(5):2030-4. doi: 10.1016/j.juro.2007.12.040. Epub 2008 Mar 19.

ReferenceCitation: Dorff T. EGFR, TS and ERCC1 expression in penile squamous cancer. ASCO GU 2011. Not yet published.

ReferenceCitation: Valverde C.M. BRAF and KRAS mutations in penile cancer and their correlation with clinical features. ASCO GU 2011. Not yet published.

ReferenceCitation: Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. doi: 10.1056/NEJMoa053422.

ReferenceCitation: Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, Chau I, Van Cutsem E. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med. 2004 Jul 22;351(4):337-45. doi: 10.1056/NEJMoa033025.

ReferenceCitation: Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajetta E, O'Byrne K, de Marinis F, Eberhardt W, Goddemeier T, Emig M, Gatzemeier U; FLEX Study Team. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525-31. doi: 10.1016/S0140-6736(09)60569-9.

ReferenceCitation: Baselga J, Pfister D, Cooper MR, Cohen R, Burtness B, Bos M, D'Andrea G, Seidman A, Norton L, Gunnett K, Falcey J, Anderson V, Waksal H, Mendelsohn J. Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. J Clin Oncol. 2000 Feb;18(4):904-14. doi: 10.1200/JCO.2000.18.4.904.

ReferenceCitation: Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. doi: 10.1016/S1470-2045(09)70311-0. Epub 2009 Nov 10. Erratum In: Lancet Oncol. 2010 Jan;11(1):14.

ReferenceCitation: Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.

ReferenceCitation: Vermorken JB, Trigo J, Hitt R, Koralewski P, Diaz-Rubio E, Rolland F, Knecht R, Amellal N, Schueler A, Baselga J. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol. 2007 Jun 1;25(16):2171-7. doi: 10.1200/JCO.2006.06.7447.

ReferenceCitation: Rescigno P, Matano E, Raimondo L, Mainolfi C, Federico P, Buonerba C, Di Trolio R, D'Aniello C, Damiano V, Palmieri G, De Placido S, Di Lorenzo G. Combination of docetaxel and cetuximab for penile cancer: a case report and literature review. Anticancer Drugs. 2012 Jun;23(5):573-7. doi: 10.1097/CAD.0b013e328350ead7.

ReferenceCitation: Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, D'Haens G, Pinter T, Lim R, Bodoky G, Roh JK, Folprecht G, Ruff P, Stroh C, Tejpar S, Schlichting M, Nippgen J, Rougier P. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009 Apr 2;360(14):1408-17. doi: 10.1056/NEJMoa0805019.

location_facility:
Institut Bergonié
Centre Léon Bérard
Institut Claudius Regaud
APHP Hôpital Saint Louis
CHRU Strasbourg
Institut Paoli Calmettes
Institut Curie


title: A 12 Month Open-label, Randomized, Multicenter, Sequential Cohort-group, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients.

summary: This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

ReferenceType: result

ReferenceCitation: Tedesco-Silva H, Kho MM, Hartmann A, Vitko S, Russ G, Rostaing L, Budde K, Campistol JM, Eris J, Krishnan I, Gopalakrishnan U, Klupp J. Sotrastaurin in calcineurin inhibitor-free regimen using everolimus in de novo kidney transplant recipients. Am J Transplant. 2013 Jul;13(7):1757-68. doi: 10.1111/ajt.12255. Epub 2013 May 9.

lead_sponsor: Novartis Pharmaceuticals

location_country:
France
Germany
Italy
Colombia
Slovakia
Norway
Argentina
Singapore
Australia
Brazil
Netherlands
Austria
Belgium
Switzerland
Spain
Taiwan
Czech Republic

location_facility:
France
Italy
Norway
Argentina
Novartis Investigative Site
Australia
Brazil
Austria
Belgium
Netherlands
Spain
Czech Republic


title: Health Behavior Change During COVID-19 Pandemic: the Focus on Handwashing

summary: This study aims at investigating handwashing behavior during COVID-19 pandemic. It was hypothesized that social-cognitive and emotional predictors as well as COVID-19 morbidity and mortality rates within the country would be associated with handwashing behavior in the general population of adults in 14 countries.

ReferenceCitation: World Health Organization. Coronavirus disease (COVID-19) advice for the public. 2020. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/advice-for-public

ReferenceCitation: Centers for Disease Control and Prevention. When and how to wash your hands. 2020. https://www.cdc.gov/handwashing/when-how-handwashing.html

ReferenceCitation: Reyes Fernandez B, Knoll N, Hamilton K, Schwarzer R. Social-cognitive antecedents of hand washing: Action control bridges the planning-behaviour gap. Psychol Health. 2016 Aug;31(8):993-1004. doi: 10.1080/08870446.2016.1174236. Epub 2016 Apr 26.

ReferenceCitation: Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.

ReferenceCitation: Ruiter RAC, Abraham C, Kok G. Scary warnings and rational precautions: A review of the psychology of fear appeals. Psychol Health. 2011;11(1): 613-630. doi: 10.1080/08870440108405863

ReferenceCitation: Luszczynska A, Szczuka Z, Abraham C, Baban A, Brooks S, Cipolletta S, Danso E, Dombrowski SU, Gan Y, Gaspar T, de Matos MG, Griva K, Jongenelis MI, Keller J, Knoll N, Ma J, Miah MAA, Morgan K, Peraud W, Quintard B, Shah V, Schenkel K, Scholz U, Schwarzer R, Siwa M, Taut D, Tomaino SCM, Vilchinsky N, Wolf H. The Interplay Between Strictness of Policies and Individuals' Self-Regulatory Efforts: Associations with Handwashing During the COVID-19 Pandemic. Ann Behav Med. 2022 Apr 2;56(4):368-380. doi: 10.1093/abm/kaab102.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repository_institution: Nanyang Technological University - DR-NTU

repository_institution: DEAKIN - Own your potential

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repository_institution: University of Lisbon - Repositório da Universidade de Lisboa

repository_institution: University of Zurich - Zurich Open Repository and Archive

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories_concat: HAL;PubMed Central;University of Melbourne - Minerva Access;dr.ntu.edu.sg;dro.deakin.edu.au;oskar-bordeaux.fr;refubium.fu-berlin.de;repositorio.ul.pt;researchonline.lshtm.ac.uk;www.zora.uzh.ch

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

ReferenceCitation: Szczuka Z, Abraham C, Baban A, Brooks S, Cipolletta S, Danso E, Dombrowski SU, Gan Y, Gaspar T, de Matos MG, Griva K, Jongenelis M, Keller J, Knoll N, Ma J, Miah MAA, Morgan K, Peraud W, Quintard B, Shah V, Schenkel K, Scholz U, Schwarzer R, Siwa M, Szymanski K, Taut D, Tomaino SCM, Vilchinsky N, Wolf H, Luszczynska A. The trajectory of COVID-19 pandemic and handwashing adherence: findings from 14 countries. BMC Public Health. 2021 Oct 5;21(1):1791. doi: 10.1186/s12889-021-11822-5.

repository_institution: Deakin University - Deakin Research Online

repository_institution: University of Padova - Padua Research Archive

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

repositories_concat: HAL;PubMed Central;University of Melbourne - Minerva Access;dr.ntu.edu.sg;dro.deakin.edu.au;oskar-bordeaux.fr;refubium.fu-berlin.de;repositorio.ul.pt;researchonline.lshtm.ac.uk;www.research.unipd.it;www.zora.uzh.ch

ipd_sharing_description:
The lead researchers in 14 countries will have full access to data collected across the countries.

In line with the Consortium Agreement (v2, 16th Jul 2020) data will be openly available under following conditions:

De-identified individual participant data that underline the results reported in publications; individual-level aggregated data (e.g., sum scores for scales) used for main analyses in respective publications; available following the publication, no end date of availability; available for analyses that are conducted to achieve aims in the approved proposal.

Due to local regulations, there are exceptions in terms of data sharing rules (stated above):

AUSTRALIA: Data from Australia will be available for 5 years after collection.
GERMANY, SWITZERLAND: Instead of individual-level sum scores, variance-covariance matrices will be shared.
MALAYSIA: Data will not be shared.

lead_sponsor: University of Social Sciences and Humanities, Warsaw

location_country: Germany Italy Poland Portugal Israel Singapore Romania Australia Gambia Switzerland China Malaysia Canada France

location_facility: SWPS University of Social Sciences and Humanities

location_facility: London School of Hygiene and Tropical Medicine (in collaboration with MRC Unit The Gambia at LSHTM)


title: A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Camostat Mesylate for the Treatment of SARS-CoV-2 Infection - COVID-19 in Ambulatory Adult Patients (CAMOVID)

acronym: CAMOVID

summary:
The overall objective of the study is to determine the therapeutic effect and tolerance of Camostat mesylate, compared to placebo in adult patients with ambulatory COVID-19 disease, presenting with risk factors of severe COVID-19. Camostat mesylate is a serine protease TMPRSS2 (Transmembrane Serine Protease 2) inhibitor which has been successfully and safely used to treat pancreatitis-associated pain and post-operative reflux oesophagitis in Japan. More recently, it has been shown to inhibit SARS-CoV-2 viral entry and reduce infection of human primary pneumocytes and lung cell lines.

Camostat mesylate or placebo will be administered to consenting adult patients with virologically confirmed COVID-19, not requiring initial hospitalization. All patients will receive standard of care along with randomized treatments. Outcomes of included patients will be compared between the 2 groups.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier Sud Ile de France - Melun


title: Venetoclax in Chronic Lymphocytic Leukemia Effectiveness and Real-life Treatment Management

acronym: VERONE

summary: This study will evaluate real-life effectiveness and use in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).

lead_sponsor: AbbVie

location_facility: CH Cannes - les Broussailles /ID# 201108

location_facility: Centre Hospitalier de Versailles André Mignot /ID# 169950

location_facility: Hopital Saint Vincent de Paul /ID# 169956

location_facility: CHR Metz-Thionville - Hopital Bel-Air /ID# 170722

location_facility: CHU Strasbourg - Hopital Civil /ID# 200195

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 170855

location_facility: CH de Saint-Malo - Hôpital Broussais /ID# 169935

location_facility: Institut de Cancérologie du Gard /ID# 169975

location_facility: CHI POISSY - Saint-Germain-en-Laye /ID# 169966

location_facility: Centre Hospitalier de Perpignan /ID# 170743

location_facility: CH de Bourg-en Bresse - Hopital Fleyriat /ID# 170017

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 200192

location_facility: CH Pontoise - Hopital René Dubos /ID# 170720

location_facility: Hopital d'Instruction des Armées PERCY /ID# 170740

location_facility: CH Annecy Genevois - Site Annecy /ID# 200826

location_facility: CH Cornouailles - Site Quimper-Laennec /ID# 169937

location_facility: CHR Orleans - Hopital de la Source /ID# 169453

location_facility: CH CARCASSONNE - Antoine Gayraud /ID# 202530

location_facility: Institut de Cancérologie du Gard /ID# 171207

location_facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 169941

location_facility: AP-HM - Hopital de la Conception /ID# 201981

location_facility: CHU Reims - Hôpital Robert Debre /ID# 170917

location_facility: Centre Hospitalier de CHOLET /ID# 171215

location_facility: CH Roubaix - Hopital Victor Provo /ID# 170909

location_facility: Clinique Pole santé République /ID# 204658

location_facility: CHU de La Réunion sites Sud - Saint-Pierre /ID# 204093

location_facility: CH Libourne - Hopital Robert Boulin /ID# 170739

location_facility: CHRU de Brest - Hopital Morvan /ID# 169457

location_facility: CHU Amiens-Picardie Site Sud /ID# 170724

location_facility: Centre Hospitalier de la Cote Basque /ID# 170735

location_facility: CHU Grenoble - Hopital Michallon /ID# 170741

location_facility: CH Pontoise - Hopital René Dubos /ID# 201329

location_facility: CH de la Haute-Saône - Vesoul /ID# 205150

location_facility: CHRU Tours - Hopital Bretonneau /ID# 169469

location_facility: CHU de Besancon - Jean Minjoz /ID# 170721


title: Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions

acronym: SOTHIS

summary: This study assesses the long?term effectiveness of adalimumab in subjects starting a treatment for ulcerative colitis in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach.

location_facility: Duplicate_Hopital Robert Ballanger /ID# 151382

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 151181

location_facility: GH Mutualiste Les Portes Du Sud /ID# 159231

location_facility: Centre Hosp Intercommunal de Creteil /ID# 152361

location_facility: GH Mutualiste Les Portes Du Sud /ID# 152374

location_facility: Hopital de la Cavale Blanche /ID# 153608

location_facility: CHU Toulouse - Hopital Purpan /ID# 167179

location_facility: CHU La Réunion - site St Denis - Félix-Guyon /ID# 151556

location_facility: CHU Toulouse - Hopital Rangueil /ID# 157890

location_facility: Centre des consultations spécialisées de la sauvegarde /ID# 151515

location_facility: Centre Hospitalier de la Cote /ID# 163714

location_facility: Centre Medical Alexandre Dumas /Id# 165857

location_facility: Centre Hépato-Biliaire - Hopital Paul-Brousse /ID# 151152

location_facility: CH Des Deux Vallees Longumeau /ID# 150977

location_facility: CHU NIMES - Hopital Caremeau /ID# 169178

location_facility: Hopital Louis Mourier,Colombes /ID# 152650

location_facility: Centre Medical du Clos de Pacy /ID# 151129

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 151132

location_facility: Hopital de la Cavale Blanche /ID# 152618

location_facility: CH La Rochelle - Hopital Saint Louis /ID# 151182

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 151147

location_facility: CHU Grenoble - Hopital Michallon /ID# 151508

location_facility: Cabinet Medical, Dr. Constant, /ID# 151119

location_facility: CHRU Tours - Hopital Trousseau /ID# 163503

location_facility: Maison de Santé Protestante Bordeaux Bagatelle /ID# 151497

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 151514

location_facility: HCL - Hopital Edouard Herriot /ID# 151513

location_facility: CH Annecy Genevois Site Annecy /ID# 151131

location_facility: AP-HP - Hopital Bichat - Claude-Bernard /ID# 151176

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 166807


title: Multicentric Randomized Trial of the Impact of Hemodialysis With Polymethylmetacrylate Membrane on the Improvement of Humoral Immune Response in the Hemodialyzed Patients: Application to Hepatitis B Vaccination and Correlation to sCD40 Clearing

acronym: HEPADIAL

summary: The aim of this study is to improve the humoral immune response efficiency of hemodialyzed patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model of anti-HBV vaccination

ReferenceCitation: de Precigout V, Germain C, Benard A, Lacraz A, Chauveau P, Deprele C, Seigneuric B, Pommereau A, Courivaud C, Douillet M, Taton B, Combe C, Contin-Bordes C. No Improvement of Hepatitis B Vaccination Response in Patients Dialysed with a Polymethylmethacrylate Membrane Compared to High-Flux Polysulfone: Results of the HEPADIAL Study. Blood Purif. 2020;49(3):265-271. doi: 10.1159/000504035. Epub 2019 Nov 13.

publisher_dissemination: S. Karger AG

location_facility:
Larrey Hospital, Dialyze Unit
CH de la côte Basque
Saint-Augustin Clinic, Dialyze Unit
Pellegrin Hospital, Nephrology Unit
CHU de Besançon
CH Annonay


title: Sequential and Early Used of Noninvasive Ventilation After Extubation in Hypercapnic Patients or in Patients With Chronic Respiratory Disorders

acronym: VHYPER

summary: The purpose of this study is to assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in patients with either chronic respiratory disorders or hypercapnic respiratory failure during spontaneous breathing.

ReferenceCitation: Vargas F, Clavel M, Sanchez-Verlan P, Garnier S, Boyer A, Bui HN, Clouzeau B, Sazio C, Kerchache A, Guisset O, Benard A, Asselineau J, Gauche B, Gruson D, Silva S, Vignon P, Hilbert G. Intermittent noninvasive ventilation after extubation in patients with chronic respiratory disorders: a multicenter randomized controlled trial (VHYPER). Intensive Care Med. 2017 Nov;43(11):1626-1636. doi: 10.1007/s00134-017-4785-1. Epub 2017 Apr 9.

publisher_dissemination: Springer-Nature

location_facility:
Saint-André Hospital
Hospital
Pellegrin Hospital, Recovery Unit
University Hospital


title: A Clinical Study to Investigate Interferon Gamma (IFNɣ) Signature in Patients Post HSCT and in Patients With Impaired HSC Proliferation Pre-transplant

summary: Clinical study designed to collect blood for research purposes in patients after hematopoietic stem cell transplantation (HSCT) or in patients with a medical condition where the blood cells production is impaired. The blood samples will be used to study the role of Interferon gamma (IFNɣ) in graft failure or impairment of hematopoietic stem cell proliferation. The IFNɣ signature will be assessed by measuring primarily IFNɣ and C-X-C Motif Chemokine Ligand 9 (CXCL9).

lead_sponsor: Swedish Orphan Biovitrum

sponsor_collaborators:
Swedish Orphan Biovitrum
PRA Health Sciences
Cytel Inc.
BioMérieux

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
France

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: Imperial College Healthcare NHS Trust NHS Trust

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Algemeen Ziekenhuis Delta - Campus Rumbeke

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Ospedale Pediatrico Bambino Gesù - Roma - Gianicolo

location_facility: Cardiff and Vale University Health Board

location_facility: Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz