intervention_type: Biological

lead_sponsor: Nektar Therapeutics

summary: The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.

ReferenceCitation: Eggermont AM, Ascierto PA, Khushalani NI, Schadendorf D, Boland G, Weber J, Lewis KD, Johnson D, Rivalland G, Khattak A, Majem M, Gogas H, Long GV, Currie SL, Chien D, Tagliaferri MA, Carlino MS, Diab A. PIVOT-12: a phase III study of adjuvant bempegaldesleukin plus nivolumab in resected stage III/IV melanoma at high risk for recurrence. Future Oncol. 2022 Mar;18(8):903-913. doi: 10.2217/fon-2021-1286. Epub 2022 Jan 25.

oa_colors: green hybrid

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

version: submittedVersion

sponsor_collaborators:
Nektar Therapeutics
Bristol-Myers Squibb

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: Theageneio Anticancer Oncology Hospital of Thessaloniki

location_facility: Lehigh Valley Physician Group (LVPG) - Hematology Oncology

location_facility: Department of Pharmacy Investigational Drug Services

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: University of Texas Southwestern Medical Center

location_facility: ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

location_facility: Metropolitan Hospital - Fourth Oncology Clinic

location_facility: University Hospitals Cleveland Medical Center

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska

location_facility: California Cancer Associates for Research and Excellence

location_facility: Utah Cancer Specialists (Salt Lake City)

location_facility: FSBI National Medical Research Center of Oncology n.a. N.N.Petrov of MHRF

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku

location_facility: University of North Carolina at Chapel Hill

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Frontier Cancer Center and Blood Institute

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: University of Colorado - Cancer Center - PPDS

location_facility: Columbia University Medical Center - PIN

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Washington University School of Medicine

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: Hematology Oncology Medical Group of Orange County, Inc.

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Kaiser Foundation Hospital, Inpatient Pharmacy

location_facility: Metropolitan Hospital - First Oncology Clinic

location_facility: Southern California Permanente Medical Group

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Providence Cancer Institute, Franz Clinic

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego w Poznaniu

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Rocky Mountain Cancer Centers (Littleton) - USOR

title: A Phase 3, Randomized, Open-label Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)

location_country:
Germany
Italy
Poland
Portugal
New Zealand
Israel
United Kingdom
Romania
Australia
Netherlands
Austria
United States
Spain
Greece
Czechia
Russian Federation
France

ipd_sharing: Undecided


title: A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

summary:
Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone.

Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Ward JP, Berrien-Elliott MM, Gomez F, Luo J, Becker-Hapak M, Cashen AF, Wagner-Johnston ND, Maddocks K, Mosior M, Foster M, Krysiak K, Schmidt A, Skidmore ZL, Desai S, Watkins MP, Fischer A, Griffith M, Griffith OL, Fehniger TA, Bartlett NL. Phase 1/dose expansion trial of brentuximab vedotin and lenalidomide in relapsed or refractory diffuse large B-cell lymphoma. Blood. 2022 Mar 31;139(13):1999-2010. doi: 10.1182/blood.2021011894.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

lead_sponsor: Seagen Inc.

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Australia
Netherlands
Switzerland
Belgium
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Carbone Cancer Center / University of Wisconsin

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Lakeridge Health - The R.S. McLaughlin Durham Regional Cancer Centre (MDRCC)

location_facility: CIUSS NIM/Hopital du Sacre-Coeur de Montreal

location_facility: Warmian-Masurian Cancer Center of The Ministry of The Interior and Administraton's Hospital

location_facility: University of Ottawa / Ottawa General Hospital

location_facility: Florida Cancer Specialists - East West Palm Beach, FL (SCRI)

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Saint Francis Hospital / Bon Secours - South Carolina

location_facility: Soon Chun Hyang University Hospital Seoul

location_facility: H. Bliss Murphy Cancer Centre / Eastern Regional Health Authority

location_facility: Florida Cancer Specialists - North Region

location_facility: Azienda Ospedaliera Cardinale Giovanni Panico

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont

location_facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

location_facility: The Oncology Institute of Hope & Innovation - California

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Centre Hospitalier Regional Metz-Thionville, Hopital Mercy

location_facility: Centre de Lutte contre le Cancer (CLCC) - Centre Antoine Lacassagne

location_facility: Centre Hospitalier Universitaire (CHU) Dijon Bourgogne

location_facility: Centre Hospitalier Metropole Savoie - Chambery

location_facility: Keimyung University Dongsan Medical Center

location_facility: Ziekenhuis Netwerk Antwerpen Campus Stuivenberg

location_facility: University of Cincinnati Cancer Institute

location_facility: Center Hospitalier Universitaire d' Angers

location_facility: AOOR Villa Sofia Cervello - Presidio V. Cervello

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: MD Anderson Cancer Center at Cooper Health

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Florida Cancer Specialists - South Region

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

location_facility: Central Coast Local Health District (Gosford and Wyong Hospitals)

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Medical University of South Carolina/Hollings Cancer Center

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Brest - Hopital Morvan

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliera Universitaria (AOU) Federico II

location_facility: Universita degli Studi di Perugia Azienda Ospedaliera di Perugia (Ospedale Santa Maria della Misericordia)

location_facility: Zealand University Hospital (Roskilde Sygehus)

location_facility: Cancer and Hematology Centers of Western Michigan / Lemmen-Holton Cancer Pavilion

location_facility: Institut de Cancerologie Hematologie Universitaire de Saint Etienne (I.CHU.SE)

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: CHD Vendee, Site de La Roche-sur-Yon, Les Oudairies

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: St. Vincent's Hospital, The Catholic University of Korea

location_facility: Centre Hospitalier Universitaire Nantes-Hotel Dieu

location_facility: Medizinische Klinik & Poliklinik III (Bonn)nUniversitätsklinikum Bonn

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


acronym: TIRHOL

lead_sponsor: BeiGene

summary: The primary objective of the study is to evaluate the efficacy of tislelizumab in participants with relapsed/refractory classical Hodgkin lymphoma, as measured by the overall response rate per the Lugano Classification, and as determined by the investigator.

sponsor_collaborators:
BeiGene
Lymphoma Study Association

location_facility: Institut d'Hematologie de Basse-Normandie

location_facility: Huntsman Cancer Center, University of Utah

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Institut Gustave Roussy- Cancer Campus Grand Paris

title: A Phase 2, Multicenter, Open-Label Study of Tislelizumab (BGB-A317) in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

type: EudraCT Number

source: euctr

design_allocation: Non-Randomized

location_country:
Australia
Belgium
United States
Puerto Rico
France

ipd_sharing: Yes


title: ALLTogether1 - A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL)

summary: ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design.

status: Recruiting

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Toft N, Birgens H, Abrahamsson J, Griskevicius L, Hallbook H, Heyman M, Klausen TW, Jonsson OG, Palk K, Pruunsild K, Quist-Paulsen P, Vaitkeviciene G, Vettenranta K, Asberg A, Frandsen TL, Marquart HV, Madsen HO, Noren-Nystrom U, Schmiegelow K. Results of NOPHO ALL2008 treatment for patients aged 1-45 years with acute lymphoblastic leukemia. Leukemia. 2018 Mar;32(3):606-615. doi: 10.1038/leu.2017.265. Epub 2017 Aug 18.

ReferenceCitation: Schramm F, Zimmermann M, Jorch N, Pekrun A, Borkhardt A, Imschweiler T, Christiansen H, Faber J, Feuchtinger T, Schmid I, Beron G, Horstmann MA, Escherich G. Daunorubicin during delayed intensification decreases the incidence of infectious complications - a randomized comparison in trial CoALL 08-09. Leuk Lymphoma. 2019 Jan;60(1):60-68. doi: 10.1080/10428194.2018.1473575. Epub 2018 Jul 3.

ReferenceCitation: Mondelaers V, Suciu S, De Moerloose B, Ferster A, Mazingue F, Plat G, Yakouben K, Uyttebroeck A, Lutz P, Costa V, Sirvent N, Plouvier E, Munzer M, Poiree M, Minckes O, Millot F, Plantaz D, Maes P, Hoyoux C, Cave H, Rohrlich P, Bertrand Y, Benoit Y; Children-s Leukemia Group (CLG) of the European Organization for Research and Treatment of Cancer (EORTC). Prolonged versus standard native E. coli asparaginase therapy in childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma: final results of the EORTC-CLG randomized phase III trial 58951. Haematologica. 2017 Oct;102(10):1727-1738. doi: 10.3324/haematol.2017.165845. Epub 2017 Jul 27.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: PubMed Central - Europe PMC

license: cc-by

license_normalized: cc-by

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_normalized: HAL

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

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
archive.ugent.be
irua

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central;archive.ugent.be;irua

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Vora A, Goulden N, Wade R, Mitchell C, Hancock J, Hough R, Rowntree C, Richards S. Treatment reduction for children and young adults with low-risk acute lymphoblastic leukaemia defined by minimal residual disease (UKALL 2003): a randomised controlled trial. Lancet Oncol. 2013 Mar;14(3):199-209. doi: 10.1016/S1470-2045(12)70600-9. Epub 2013 Feb 7.

ReferenceCitation: Pieters R, de Groot-Kruseman H, Van der Velden V, Fiocco M, van den Berg H, de Bont E, Egeler RM, Hoogerbrugge P, Kaspers G, Van der Schoot E, De Haas V, Van Dongen J. Successful Therapy Reduction and Intensification for Childhood Acute Lymphoblastic Leukemia Based on Minimal Residual Disease Monitoring: Study ALL10 From the Dutch Childhood Oncology Group. J Clin Oncol. 2016 Aug 1;34(22):2591-601. doi: 10.1200/JCO.2015.64.6364. Epub 2016 Jun 6.

ReferenceCitation: Toksvang LN, Als-Nielsen B, Bacon C, Bertasiute R, Duarte X, Escherich G, Helgadottir EA, Johannsdottir IR, Jonsson OG, Kozlowski P, Langenskjold C, Lepik K, Niinimaki R, Overgaard UM, Punab M, Raty R, Segers H, van der Sluis I, Smith OP, Strullu M, Vaitkeviciene G, Wik HS, Heyman M, Schmiegelow K. Thiopurine Enhanced ALL Maintenance (TEAM): study protocol for a randomized study to evaluate the improvement in disease-free survival by adding very low dose 6-thioguanine to 6-mercaptopurine/methotrexate-based maintenance therapy in pediatric and adult patients (0-45 years) with newly diagnosed B-cell precursor or T-cell acute lymphoblastic leukemia treated according to the intermediate risk-high group of the ALLTogether1 protocol. BMC Cancer. 2022 May 2;22(1):483. doi: 10.1186/s12885-022-09522-3.

repository_institution: University of Helsinki - Helda

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of Oulu - University of Oulu Repository - Jultika

repositories_concat: HELDA - Digital Repository of the University of Helsinki;LIRIAS (KU Leuven);PubMed Central;opinvisindi.is;oulu.fi

ipd_sharing_description:
ALLTogether Data Sharing Policy FINAL VERSION 1.0 DATED 12APRIL2022 applies (full details available from Trial Central Office):

Policy

The ALLTogether Consortium aims to maximise the availability of research data to the academic community for academic non-commercial research purposes with as few restrictions as possible.
All research papers should be open access whenever possible.
Clinical data: The ALLTogether Consortium will consider requests for individual participant data (IPD) that underlie published results after deidentification. Requests for access for unpublished data will also be considered on a case-by-case basis.
ALLTogether scientific data underpinning basic science/translational research papers should be made available to other researchers in the ALLTogether consortium and requests from academic researchers outside the consortium for access to scientific datasets should be addressed to the lead investigator of the ALLTogether study.

collaborators: German Society for Pediatric Oncology and Hematology GPOH gGmbH

collaborators: Clinical Trial Center North (CTC North GmbH & Co. KG)

collaborators: Acreditar - Associação de Pais e Amigos das Crianças com Cancro

collaborators: Grupo Português De Leucemias Pediátricas

sponsor_collaborators: Grupo Português De Leucemias Pediátricas

location_country:
Finland
Germany
Ireland
Lithuania
Portugal
Norway
United Kingdom
Denmark
Sweden
Netherlands
Belgium
Iceland
Estonia
France

location_facility: University Hospital of North Norway, Dept of Paediatrics

location_facility: Oslo University Hospital, Dept of Haematology

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

location_facility: CHU Bordeaux - Groupe Hospitalier Pellegrin

location_facility: Helsinki University Hospital, Dept of Paediatrics

location_facility: Oulu University Hospital, Dept of Haematology, Dept of Medicine

location_facility: Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos

location_facility: Odense University Hospital, Dept of Paediatrics

location_facility: Oslo University Hospital, Dept of paediatric haemato- and oncology

location_facility: Alder Hey Children's Hospital, Liverpool

location_facility: University Hospital North Norway, Dept of Haematology

location_facility: CHU de Nancy - Hôpital de Brabois Enfant

location_facility: Stavanger University Hospital, Dept of Haematology

location_facility: Southampton General Hospital, Southampton

location_facility: Oulu University Hospital, Dept of Paediatrics

location_facility: Bristol Royal Hospital for Children / Bristol Haematology and Oncology Centre

location_facility: Helsinki University Hospital, Dept of Haematology

location_facility: University Hospital Leuven, Dept of Paediatrics

location_facility: Aalborg University Hospital, Dept of Paediatrics

location_facility: CHC MontLégia, Boulevard Patience et Beaujonc 2

location_facility: Linköping University Hospital, Dept of Haematology

location_facility: CHU de Grenoble site Nord - Hôpital Albert Michallon

location_facility: Haukeland University Hospital, Dept of Haematology

location_facility: Tallinn Children´s Hospital, Dept of Paediatrics

location_facility: Sahlgrenska University Hospital, Section for Haematology and coagulation

location_facility: Tampere University Hospital, Dept of Paediatrics

location_facility: Turku University Hospital, Dept of Paediatrics

location_facility: Linköping University Hospital, Dept of Paediatrics

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: North Estonia Medical Centre, Dept of Haematology

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE - Hospital Pediátrico de Coimbra

location_facility: Cliniques Universitaires Saint-Luc (UCL)

location_facility: Norrland University Hospital, Dept of Haematology

location_facility: University Medical Center Utrecht, Dept of Hematology

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: Great Ormond Street Hospital for Children, London

location_facility: St. Olavs University Hospital, Dept of Paediatrics

location_facility: CHU De La Réunion - Site Nord (Hôpital Félix GUYON)

location_facility: Aarhus University Hospital, Child and Adolescent Health

location_facility: Uppsala University Hospital, Dept of Haematology

location_facility: Haukeland University Hospital, Dept of Paediatrics

location_facility: St. Olavs University Hospital, Dept of Haematology

location_facility: University College London Hospital, London

location_facility: Birmingham Children's Hospital, Birmingham

location_facility: Princess Máxima Center for Pediatric Oncology

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Royal Aberdeen Children's Hospital, Aberdeen

location_facility: Skåne University Hospital, Dept of Paediatrics

location_facility: Kuopio University Hospital, Dept of Haematology

location_facility: Beatson West of Scotland Cancer Centre, Glasgow

location_facility: Norrland University Hospital, Dept of Paediatrics

location_facility: Noah's Ark Children's Hospital for Wales, Cardiff

location_facility: Tampere University Hospital, Dept of Haematology

location_facility: Landspitali University Hospital, Children's Hospital

location_facility: CHU de Lyon HCL - GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP

location_facility: Sheffield Children's Hospital, Sheffield

location_facility: CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: L'hôpital Universitaire des enfants Reine Fabiola (Huderf)

location_facility: Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit

location_facility: Karolinska University Hospital, Patient area Haematology

location_facility: Royal Hospital for Children and Young People, Edinburgh

location_facility: Kuopio University Hospital, Dept of Paediatrics

location_facility: Sahlgrenska University Hospital, Dept of Paediatric Haematology and Oncology

location_facility: Uppsala University Hospital, Dept of Paediatric Haematology and Oncology

location_facility: Skåne University Hospital, Dept of Haematology

location_facility: Royal Manchester Children's Hospital, Manchester

location_facility: Örebro University Hospital, Section for Haematology

location_facility: Karolinska University Hospital, Dept of Paediatric Oncology and Haematology

location_facility: The Queen Elizabeth Hospital, Birmingham

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Royal Belfast Hospital for Sick Children, Belfast


lead_sponsor: Amgen

summary: A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

ReferenceCitation: de Langen AJ, Johnson ML, Mazieres J, Dingemans AC, Mountzios G, Pless M, Wolf J, Schuler M, Lena H, Skoulidis F, Yoneshima Y, Kim SW, Linardou H, Novello S, van der Wekken AJ, Chen Y, Peters S, Felip E, Solomon BJ, Ramalingam SS, Dooms C, Lindsay CR, Ferreira CG, Blais N, Obiozor CC, Wang Y, Mehta B, Varrieur T, Ngarmchamnanrith G, Stollenwerk B, Waterhouse D, Paz-Ares L; CodeBreaK 200 Investigators. Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trial. Lancet. 2023 Mar 4;401(10378):733-746. doi: 10.1016/S0140-6736(23)00221-0. Epub 2023 Feb 7.

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Fundacao Antonio Prudente - Hospital A C Camargo

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu

location_facility: Omsk Regional Clinical Oncology Dispensary

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico

location_facility: Hospital of the University of Occupational and Environmental Health

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Medical Oncology Hematology Consultants Helen F Graham Cancer Center

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center

location_facility: Harbor University of California Los Angeles Medical Center

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula

location_facility: Severance Hospital Yonsei University Health System

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: The Center for Cancer and Blood Disorders

location_facility: Algemeen Ziekenhuis Nikolaas Campus Sint Niklaas

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

location_facility: Saint Petersburg scientifical practical center of specialized kinds of medical care oncological

location_facility: University of California San Francisco Mission Hall

location_facility: Kobe City Medical Center General Hospital

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Centre Hospitalier Universitaire RÃ©gional de Lille - HÃ´pital Albert Calmette

location_facility: Centre Hospitalier de L'Universite de Montreal Hopital Notre-Dame

location_facility: Instituto Catalan de Oncologia Hospital Duran i Reynals

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Centre Hospitalier de Nantes - HÃ´pital Nord LaÃ"nnec

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente

location_facility: Centro de Tratamento de Tumores Botafogo

location_facility: Studiengesellschaft HÃ¤mato Onkologie Hamburg Prof Laack und Partner

location_facility: Charite UniversitÃ¤tsmedizin Berlin, CharitÃ© Campus Virchow-Klinikum

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Azienda UnitÃ Sanitaria Locale della Romagna Presidio ospedaliero di Ravenna

location_facility: General Oncology Hospital of Kifissia Agioi Anargyroi

location_facility: Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati

location_facility: Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Hospital Regional Universitario de Malaga

location_facility: Complexo Hospitalario Universitario A CoruÃ±a Hospital Teresa Herrera

location_facility: National Hospital Organization Iwakuni Clinical Center

location_facility: Florida Cancer Specialists Research Panhandle

location_facility: US Oncology Research Investigational Products Center

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: St Marianna University School of Medicine Hospital

location_facility: Dolnoslaskie Centrum Onkologii we Wroclawiu

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: Asklepios - Fachkliniken MÃ¼nchen-Gauting

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Azienda Socio Sanitaria Territoriale di Monza Ospedale San Gerardo

location_facility: Montefiore Einstein Center for Cancer Care

location_facility: University of California at Davis Medical Center

location_facility: Azienda Ospedaliera di Rilievo Nazionale Specialistica dei Colli Monaldi

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: Instytut Genetyki i Immunologii GENIM Spzoo

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Chugoku Central Hospital of Japan Mutual Aid Association of Public School Teachers

location_facility: Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

location_facility: Shiga University of Medical Science Hospital

location_facility: Centro Hospitalar Universitario de Sao Joao EPE - Hospital Sao Joao

location_facility: Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio

location_facility: Cha Bundang Medical Center, Cha University

location_facility: Washington Cancer Institute at MedStar Washington Hospital

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: FSBI Scientific and Research Oncology Institute named after N N Petrov

location_facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: Centre Hospitalier Regional Universitaire - Hopital Morvan

location_facility: Centrum Onkologii Instytut im Marii Sklodowskiej-Curie

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Florida Cancer Specialists Research North

location_facility: Centre Hospitalier Intercommunal de CrÃ©teil

location_facility: Clinical hospital 2, Group of companies medsi

location_facility: United States Oncology Regulatory Affairs Corporate Office

title: A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Finland
Germany
Poland
Australia
Brazil
Japan
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden


title: Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events in Europe - a MultInatioNal ObservatIonal Study (SANTORINI)

acronym: SANTORINI

summary: High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Other

ipd_sharing: No

lead_sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

location_country:
Finland
Germany
Ireland
Italy
Portugal
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
France

location_facility: Kliniken an der Paar - Krankenhaus Aichach

location_facility: B. Braun Ambulantes Herzzentrum MVZ GmbH

location_facility: Kardiologische Gemeinschaftspraxis Dres. Wetzel/Willgeroth

location_facility: Ospedale di Santo Stefano di Prato - Azienda Usl Toscana centro (UO di Cardiologia)

location_facility: Ospedale Civile Santa Maria Incoronata dell'Olmo

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Studienzentrum der Inneren Medizin I & II am Klinikum Konstanz

location_facility: Ropcke Zweers hospital, Jan Weitkamplaan 4-a

location_facility: Ijsselland Ziekenhuis, Prins Constanijnweg 2

location_facility: Ordination Dr. med. univ. Evelyn Fließer-Görzer

location_facility: Zentrum für Klinische Studien Dr. Hanusch GmbH

location_facility: Kobenhavns Universitet - Holbaek Sygehus

location_facility: Ospedale Santo Stefano di Prato - Azienda Usl Toscana Centro

location_facility: Gemeinschaftspraxis Dres. J. Hintze und M. Grundner

location_facility: Hospital Universitario de la Princesa Site 11075

location_facility: Centro Hospitalar Lisboa Norte - Site 10005

location_facility: A.O.U. Consorziale - Policlinico Bari (Dipartimento di Medicina Interna)

location_facility: Kardiologische Praxis Papenburg (Site 6097)

location_facility: Konventhospital der Barmherzigen Brüder Linz

location_facility: Presidio ospedaliero Cardinal Massaia - A.S.L. AT (SOC Diabetologia e Malattie Metaboliche)

location_facility: Ospedale Civile SS Annunziata (Dipartimento di Medicina Clinica e Sperimentale)

location_facility: Ordination Dr. Thomas Maca / Evangelisches KH Wien

location_facility: Ospedale SS Cosma e Damiano di Pescia - Azienda Usl Toscana centro

location_facility: Ordination Dr. Thomas Maca / Evangelische KH Wien

location_facility: Zentrum für Prävention und Rehabilitation

location_facility: Karolinska University Hospital, Huddinge

location_facility: A.O.U. "San Giovanni di Dio e Ruggi d'Aragona"

location_facility: Sastamalan seudun sosiaali- ja terveyspalvelut

location_facility: A.O.U. Policlinico "G. Martino" (U.O. Cardiologia)

location_facility: A.O.U. Careggi (S.O.D. Malattie Aterotrombotiche) - Site 8020

location_facility: Herzquartier Mühlheim, Kardiologische Gemeinschaftspraxis Dres. med. A. Krapivsky & P. Kekes

location_facility: Azienda Ospedaliera Universitaria Mater Domini - Site 8053

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Centro Hospitalar Lisboa Norte - Site 10006

location_facility: A.O.U. FEDERICO II (U.O.C. Diabetologia)

location_facility: Centro Hospitalar Universitario do Algarve

location_facility: Kardiologie Oberschwaben - Bodensee Herz- und Gefäßpraxis

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: MVZ Dres. Ramdohr - Praxis für Cardiovascular und Ultraschalldiagnostik

location_facility: Centre Hopsitalier Alpes Leman, 552 Route de Findrol

location_facility: Azienda Ospedaliera San Giovanni Addolorata

location_facility: Östra Sahlgrenska Universitetssjukhuset - Ostra Sjukhuse

location_facility: Hospital de Alta Resolución de Sierra Norte

location_facility: Azienda Ospedaliero-Universitaria Senese Dipartimento Delle Scienze Mediche U.O.C. Medicina Interna e della Complessità

location_facility: Complejo Hospitalario Universitario de Ourense (CHOU) Site 11003

location_facility: Ente Ecclesiastico Ospedale Generale Regionale "F.Miulli"

location_facility: Zentrum für klinische Prüfungen in der Facharztzentrum Dresden-Neustadt GbR

location_facility: Kardiologische Facharztpraxis Dr. Anne Winkelmann

location_facility: Krankenhaus Hietzing mit neurologischem Zentrum Rosenhügel

location_facility: Internistische Facharztpraxis Frau Dr. Carmen Gelsinger

location_facility: Zentrum für Diabetes und Gefäßerkrankungen Münster

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Complejo Hospitalario Universitario de Ourense (CHOU) Site 11052

location_facility: Praxis für Herzkreislauferkrankungen Greiz

location_facility: Azienda Ospedaliera-Universitaria S. Anna di Ferrara (Dipartimento medico)

location_facility: Hausärztlich-Kardiologisches MVZ "Am Felsenkeller" GmbH

location_facility: Centro Hospitalar Universitário São João (CHUSJ)

location_facility: Presidio Ospedaliero "Santa Maria della Misericordia" di Udine

location_facility: Praxis für Innere Medizin / Kardiologie - Dr. med. E. Persicke / Dr. med. O. Scheuermann

location_facility: Ospedale S. Andrea - Usl Toscana Sud Est

location_facility: Arcispedale Sant'Anna Ferrara (U.O. Cardiologia)

location_facility: Ospedale di Bolzano (U.O. Cardiologia e Prove Funzionali)

location_facility: Praxis Dipl. - Med. Petra Herrmann - Fachärztin für Innere Medizin

location_facility: ASL Roma 6 - Ospedali Riuniti Anzio - Nettuno

location_facility: Centre de Cardiologie et d'exploration de la Côte Basque

location_facility: Ospedale Civile di Baggiovara- AOU di Modena

location_facility: Ospedali Riuniti "Umberto I - Lancisi - Salesi

location_facility: Centro Cardiologico Monzino - IRCCS (Unità Prevenzione dell'Aterosclerosi)

location_facility: Ordination Universitätsdozent Dr. Alexander Kober

location_facility: Centre Hospitalier de Lisieux, 4 Rue Roger Aini

location_facility: Fondazione Poliambulanza Istituto Ospedaliero - Brescia

location_facility: Presidio Ospedaliero di Mirano - ULSS 3 Serenissima

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Praxis für Innere Medizin und Angiologie

location_facility: Institut Cœur Poumons, Boulevard du Pr Leclercq

location_facility: Azienda Ospedaliera Universitaria Mater Domini - Site 8042

location_facility: A.O. San Giuseppe Moscati (U.O.C. Cardiologia/UTIC)

location_facility: Praxis für Gefäßerkrankungen und Gerinnungsstörungen Leipzig

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Kardiologische Praxis Papenburg (Site 6098)

location_facility: Centro Hospitalar de Entre Douro e Vouga

location_facility: A.O.U di Bologna-Policlinico S.Orsola-Malpighi (U.O. Medicina Interna)

location_facility: Hospital Universitario de la Princesa Site 11054

location_facility: Azienda Ospedaliera Universitaria Mater Domini - Site 8059

location_facility: Gemeinschaftspraxis Drs. Haggenmiller/Jeserich Kardiologie-Angiologie-Innere Medizin

location_facility: Gemeinschaftspraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte

location_facility: Krankenhaus der Barmherzigen Brüder Trier

location_facility: Policlinico Sant'Orsola-Malpighi (U.O. Cardiologia)

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Rigshospitalet (Copenhagen University Hospital) - Glostrup (Glostrup Hospital)

location_facility: Ospedale Civile SS. Annunziata (MEDICINA INTERNA- DIPARTIMENTO DI MEDICINA E SCIENZE DELL'INVECCHIAMENTO)

location_facility: MVZ Prof. Detlef Mathey, Prof. Schofer GmbH

location_facility: Hospital de Sant Joan Despí Moisès Broggi

location_facility: Associação Protetora de Diabéticos de Portugal

location_facility: Ospedale Cisanello - A.U.O.P. Azienda Ospedaliera Universitaria Pisana

location_facility: Gemeinschaftspraxis Dr. Jens Biesenbaum und Dr. Uwe Gerbaulet

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Hospital Universitario de la Princesa Site 11062

location_facility: Kardiologie im Friedrichspalast Bruchsal

location_facility: Gemeinschaftspraxis Dr. Täschner/Dr. Bonigut

location_facility: Azienda Ospedaliera di Rilievo Nazionale(A.O.R.N.) "Sant'Anna e San Sebastiano" di Caserta

location_facility: Liverpool Heart & Chest Hospital NHS Trust

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (U.O Medicina Generale 2)

location_facility: Grande Ospedale Metropolitano di Niguarda

location_facility: Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Arcispedale Santa Maria Nuova - Azienda USL/IRCCS Reggio Emilia

intervention_type: Other

status_simplified: Completed


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this extension study is to evaluate maintenance of HiSCR response at Week 104 in either continuous or interrupted therapy (using a randomized withdrawal period) of two dose regimens and to assess long-term efficacy, safety and tolerability of secukinumab in subjects with moderate to severe hidradenitis suppurativa completing either of the 2 Phase III studies. This is an expanded access trial for the core trials AIN457M2301 (NCT03713619) and AIN457M2302 (NCT03713619).

location_facility:
Novartis Investigative Site
Tufts Medical Center .

title: A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab to Demonstrate Long-term Efficacy, Safety and Tolerability in Subjects With Moderate to Severe Hidradenitis Suppurativa

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Poland
Argentina
Australia
Japan
Vietnam
Turkey
Croatia
Czechia
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Switzerland
United States
India
Lebanon
Belgium
Malaysia
Philippines
Italy
Guatemala
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: Observational Study on Inappropriate Therapies After Replacement of ICDs

acronym: OSIRIS

summary: The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)

time_perspective: Prospective

ipd_sharing_description: A clinical study report will be completed at the end of the study and publication of study results may be performed

lead_sponsor: MicroPort CRM

location_country:
Germany
Italy
Portugal
United Kingdom
Netherlands
Austria
Belgium
Switzerland
United States
Spain
France

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Grande Ospedale Metropolitano Niguarda Ca Granda

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

location_facility: The University of Chicago Medicine Hospital

location_facility: Universitätsklinik Innsbruck - Kardiologie und Angiologie

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Di Trieste

intervention_type: Device


acronym: CheckMate 7DX

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.

location_facility: Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology of the

location_facility: Russian Scientific Centre of Radiology and Surgical Technologies n.a. acad. M.A.

location_facility: Budgetary Healthcare Institution of Omsk Region &quot,Clinical Oncological Dispensary&quot,

location_facility: SAHI Republican Clinical Oncology Dispensary of MoH of RT

location_facility: The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center

location_facility: FSBI National Medical Research Radiology Center NMRRC - A. Tsyb Medical Radiological Research Centre

location_facility: P.A. Herzen Moscow Oncology Research Institute

location_facility: SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary

title: A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Hong Kong
United States
Romania
Belgium
China
Puerto Rico
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


acronym: ASTONISH

lead_sponsor: Inotrem

summary: This is a randomized, double-blind, placebo-controlled dose-selection study in which two doses of nangibotide are tested versus placebo.

ReferenceCitation: Francois B, Lambden S, Gibot S, Derive M, Olivier A, Cuvier V, Witte S, Grouin JM, Garaud JJ, Salcedo-Magguilli M, Levy M, Laterre PF. Rationale and protocol for the efficacy, safety and tolerability of nangibotide in patients with septic shock (ASTONISH) phase IIb randomised controlled trial. BMJ Open. 2021 Jul 7;11(7):e042921. doi: 10.1136/bmjopen-2020-042921.

publisher_dissemination: British Medical Journal

location_facility: Hôpital d'instruction des Armées Robert Picqué

location_facility: Hospital universitario DR. Peset Aleixandre

location_facility: Helsinki University Hospital Adult ICU PPDS

location_facility: Hospital Universitario Dentral de Asturias

location_facility: Hospital Universitario y Politecnico la Fe

title: Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock. A Randomized, Double-blind, Placebo Controlled Dose Selection Study

location_country: Finland Ireland Denmark Belgium Spain France


title: LBL 2018 - International Cooperative Treatment Protocol for Children and Adolescents With Lymphoblastic Lymphoma

summary:
Primary objectives:

Randomization R1, all patients eligible: To examine, whether the cumulative incidence of relapses with involvement of the CNS (CNS relapse, pCICR) can be decreased by a modified induction therapy including dexamethasone (experimental arm) instead of prednisone (standard arm)
Randomization R2, only patients with high risk LBL eligible: to examine, whether the probability of event-free survival (pEFS) in these patients can be improved by receiving an intensified treatment arm versus a standard treatment arm (as used in the EURO-LB 02)

ReferenceCitation: Khanam T, Sandmann S, Seggewiss J, Ruether C, Zimmermann M, Norvil AB, Bartenhagen C, Randau G, Mueller S, Herbrueggen H, Hoffmann P, Herms S, Wei L, Woeste M, Wuensch C, Gowher H, Oschlies I, Klapper W, Woessmann W, Dugas M, Burkhardt B. Integrative genomic analysis of pediatric T-cell lymphoblastic lymphoma reveals candidates of clinical significance. Blood. 2021 Apr 29;137(17):2347-2359. doi: 10.1182/blood.2020005381.

lead_sponsor: University Hospital Muenster

collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)

sponsor_collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)

location_country:
Finland
Germany
Ireland
Poland
Czechia
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
Belgium
China
Italy
Norway
Sweden
Netherlands
Austria
Spain
Russian Federation
Israel

location_facility: Service d'oncolologie, Hématologie pédiatrique. CHU Amiens, Avenue René Laënnec - SALOUEL

location_facility: Centro Hospitalar e Universitário de Coimbra

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Department of Pediatrics, Children Hematology nad Oncology, Pomeranian Medical University

location_facility: Oncologia Pediatrica,- Ospedale "R. Silvestrini"

location_facility: Kuopio University Hospital, Department of Pediatric Hematology and Oncology

location_facility: Oncoematologia Pediatrica- Ospedale dei Bambini G. di Cristina

location_facility: U.O. di Pediatria e Oncoematologia Pediatrica. Az. Osp. di Parma

location_facility: Department of Pediatric Hematology, Oncology and Transplantology, Medical University of Lublin

location_facility: Hospital Clínico Universitario de Santiago

location_facility: Aarhus University Hospital, Department of Pediatrics

location_facility: Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin

location_facility: Klinikum Dortmund gGmbH, Klinik für Kinder- und Jugendmedizin, Station K1, Abt. Päd. Onkologie / Hämatologie

location_facility: Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV: Päd. Hämatologie und Onkologie

location_facility: Johannes Wesling Klinikum Minden, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie, Station E 22

location_facility: Department of pediatric oncology and hematology, Children´s Faculty Hospital

location_facility: Département de Pédiatrie et Génétique Médicale CHRU Morvan

location_facility: Universitätsklinikum Greifswald KdöR, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Onkologie und Hämatologie

location_facility: Department of Pediatric Hematology and Oncology, Silesian Medical University in Katowice

location_facility: Oncological center of regional Children's Hospital

location_facility: Universitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Hämatologie / Onkologie

location_facility: Pôle pédiatrie Hémato-cancérologie pédiatrique- CHU RENNES - Hôpital sud

location_facility: Städtisches Klinikum Karlsruhe gGmbH, Kinderklinik, Station S 24

location_facility: Ruth Rappaport Children's Hospital, Rambam Medical Center

location_facility: Klinikum Mannheim gGmbH, Universitäts-Kinderklinik, Päd. Onkologie /Hämatologie

location_facility: Universitätsklinikum Regensburg, Klinik für Kinder- und Jugendmedizin, Abt. Päd. Hämatologie, Onkologie, SZT

location_facility: U.O. Pediatria Ospedale Infermi- Azienda USL Rimini

location_facility: U.O. Emato-Oncologia Pediatrica- Università degli studi di Trieste-Ospedale Infantile Burlo Garofolo

location_facility: Service onco hématologie pédiatrique CHU de Grenoble site Nord - Hôpital Couple enfant

location_facility: U. O. di Pediatria- Azienda Ospedaliera Annunziata

location_facility: Tampere University Hospital, Paediatric Haematology and Oncology

location_facility: Dipartimento di Medicina Clinica e Sperimentale Sezione di Pediatria - Università di Ferrara

location_facility: Hôpital Universitaire des Enfants Reine Fabiola (ULB), Pédiatrie hémato-oncologie

location_facility: HELIOS Klinikum Erfurt GmbH, Klinik für Kinder- und Jugendmedizin, Päd. Onkologie / Hämatologie

location_facility: Edmond and Lily Safra Children's Hospital, Sheba Medical Center

location_facility: Carl-Thiem-Klinikum, Kinderklinik, Station 5e

location_facility: Dipartimento di Ematologia -Ospedale Civile

location_facility: Department of Pediatrics, Hematology, Oncology and Endocrinology, Medical University of Gdansk

location_facility: Dipartimento di Ematologia e Oncologia Pediatrica Istituto " G. Gaslini"

location_facility: Klinikum der LMU, Dr. von Haunersches Kinderspital, Pädiatrische Hämatologie / Onkologie

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Clinica Pediatrica Ospedale S. Gerardo Via Donizetti

location_facility: Unità Autonoma di Oncoematologia Pediatrica, Dipartimento Pediatria - Azienda "A.Meyer"

location_facility: Instituto Português de Oncologia - Francisco Gentil - Libosa

location_facility: Department of Pediatrics, Hematology and Oncology, Medical University of Warsaw

location_facility: Service Pédiatrie - Hématologie Immunologie Oncologie - CHU Toulouse

location_facility: CHR Citadelle Hémato - oncologie pédiatrique

location_facility: Universitätsklinikum Schleswig Holstein Campus Lübeck, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie

location_facility: Department of pediatric hematology and oncology, National Institute of Children's Diseases

location_facility: Barncancercentrum, Drottning Silvias Barn och Ungdomssjukhus, Sahlgrenska Universitetssjukhuset

location_facility: Dipartimento di Scienze Pediatriche Mediche Chirurgiche Ospedale Sant'Orsola Malpighi

location_facility: Asklepios Klinik St. Augustin GmbH, Kinder- und Jugendmedizin, Kinder-Hämatologie und Onkologie

location_facility: Universitätsklinikum Leipzig, Klinik für Kinder und Jugendliche, Abt. Päd. Hämatologie / Onkologie

location_facility: service d'oncologie pédiatrique, institut Curie

location_facility: Universitätsklinik Carl Gustav Carus der TU Dresden, Klinik für Kinder- und Jugendmedizin

location_facility: Service Oncologie-Hématologie pédiatrique CHU de Poitiers

location_facility: Turku University Hospital, Paediatric and Adolescent Haematology and Oncology

location_facility: Barnavdelningen för blod- och tumörsjukdomar 95A, Akademiska sjukhuset

location_facility: University Hospital Brussels, Pediatrische oncologie

location_facility: Universitätsklinikum Rostock, Kinder- und Jugendklinik, Päd. Hämatologie und Onkologie

location_facility: HELIOS Klinikum Berlin-Buch, Kinderklinik, Pädiatrische Hämatologie und Onkologie

location_facility: Klinikum Stuttgart, Olgahospital Zentrum für Kinder- und Jugendmedizin Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)

location_facility: Department of Paediatric Oncology and Haematology, University of Rzeszów, Department of Pediatrics

location_facility: Unité d'hématologie pédiatrique CHRU de Lille - Hôpital Jeanne de Flandre

location_facility: Service d'hémato-oncologie pédiatrique- CHU de Nancy - Hôpital de Brabois Enfant

location_facility: Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie

location_facility: Universitäts-Kinderspital beider Basel (UKBB)

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Princess Maxima Centre for Pediatric Oncology

location_facility: Dana Children's Hospital, Tel-Aviv Sourasky Medical Center

location_facility: Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie

location_facility: Georg-August-Universität Universitäts-Kinderklinik, Pädiatrie I

location_facility: Divisione Ematologia - Oncologia Pediatrica, Clinica Pediatrica

location_facility: Service Immuno-Hématologie Oncologie Pédiatrique

location_facility: Barnonkologiska enheten, Barn och Ungdomsmedicinska kliniken, Universitetssjukhuset i Linköping

location_facility: Department of Pediatric Oncology, Children's Memorial Health Institute

location_facility: Luzerner Kantonspital - Kinderspital Luzern

location_facility: Service d'immuno-hématologie pédiatrique et de transplantation de moelle osseuse, CHU de Lyon HCL - GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP

location_facility: Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Children's Hospital at Soroka Medical Center

location_facility: Vestische Kinderklinik, Universität Witten / Herdecke

location_facility: University Hospitals Leuven, Kinderhemato-oncologie

location_facility: Service d'hématologie et oncologie pédiatriques, Hôpital enfant-adolescent, CHU NANTES

location_facility: Univ.Klinik für Kinder- und Jugendheilkunde Graz, Klin. Abteilung für pädiatrische Hämato-Onkologie

location_facility: Divisione di Oncologia Pediatrica Ist. Nazionale Studio e Cura Tumori

location_facility: Dept. of Pediatric Oncology, University Hospital Brno and Faculty of Medicine, Masaryk University Cernopolni

location_facility: Klinikum Augsburg ,Schwäbisches Kinderkrebszentrum. I. Klinik für Kinder und Jugendliche Hämatologie / Onkologie

location_facility: LKH Salzburg, Universitätsklinik für Kinder- und Jugendheilkunde, Kinderonkologie

location_facility: Service d'hémato-oncologie pédiatrique CHU NICE - Hôpital l'Archet 2

location_facility: Evangelisches Krankenhaus Bielefeld GmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie und Onkologie

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie

location_facility: Medizinische Hochschule Hannover, Kinderheilkunde, Päd. Hämatologie / Onkologie

location_facility: Universitätsklinikum Hamburg Eppendorf, Zentrum für Kinder- und Jugendmedizin, Abt. Pädiatrische Hämatologie und Onkologie

location_facility: National Center for Pediatric Hematology, Oncology and Immunology Moscow

location_facility: Klinikum Oldenburg AöR, Zentrum für Kinder- und Jugendmedizin, Abt. Hämatologie / Onkologie

location_facility: Service d'Hémato-Oncologie Pédiatrique- American Hospital

location_facility: Service d'Onco-Hematologie Pediatrique CHU STRASBOURG -Hôpital de Hautepierre

location_facility: Department of Pediatrics, Oncology, Hematology and Diabetology, Institute of Pediatrics, Medical University of Lodz

location_facility: Cliniques Universitaires Saint-Luc (UCL), Hématologie et oncologie pédiatrique

location_facility: Service de Pédiatrie et hématologie pédiatrique, CHU de Marseille - Hôpital de la Timone

location_facility: Hospital General Universitario de Alicante

location_facility: Universitätsklinikum Halle (Saale), Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie / Onkologie

location_facility: Divisione di Ematologia Pediatrica- Ospedale "Bambino Gesù". Istituto di Ricerca Scientifica

location_facility: Department of Pediatric Oncology and Hematology, Medical University of Bialystok

location_facility: Service d' hémato-immunologie CHU Paris - Hôpital Robert Debré

location_facility: Diakonie Neuendettelsau, Kliniken Hallerwiese / Cnopf'sche Kinderklinik, Pädiatrische Hämatologie /Onkologie

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Regional Universitario de Málaga

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: Barncanceravdelningen Astrid Lindgrens Barnsjukhus, Nya Karolinska Universitetssjukhuset

location_facility: University Hospital Aalborg, Nord, Department of Pediatrics

location_facility: S.C. Ematologia Oncologica- Ospedale "Pausilipon"

location_facility: Universitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin, Klinik für Päd. Hämatologie und Onkologie

location_facility: Klinikum Bremen-Mitte gGmbH, Prof.-Hess-Kinderklinik,Pädiatrische Onkologie und Hämatologie

location_facility: HELIOS Kliniken Schwerin GmbH, Klinik für Kinder- und Jugendmedizin, Station A1

location_facility: Hôpital de Enfants, Unité Onco-Hématologie Pédiatrique, Groupe Hospitalier Pellegrin

location_facility: Hospital Universitario Central de Asturias

location_facility: Charité Campus Virchow-Klinikum, Zentrum für Kinder- und Jugendmedizin- Abt. Hämatologie / Onkologie

location_facility: Universitätsklinikum Erlangen, Klinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie / Hämatologie

location_facility: Universitätsklinikum Aachen .Klinik für Kinder - und Jugendmedizin Hämatologie / Onkologie

location_facility: Sezione Ematologia- Dipart. Biotecnico Cellulare ed Ematologia- Università "La Sapienza"

location_facility: Børneonkologisk afsnit 5054, BørneUngeKlinikken, Juliane Marie Centret, Rigshospitalet

location_facility: HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin, Päd. Hämatologie/Onkologie

location_facility: Gemeinschaftsklinikum Mittelrhein Kemperhof, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie

location_facility: Service Hémato-immuno- oncologie- CHU PARIS Armand Trousseau

location_facility: Department of Bone Marrow Transplantation, Children Oncology and Hematology, Wroclaw Medical University

location_facility: Clinica di Oncoematologia Pediatrica- Azienda Ospedaliera-Università di Padova

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: University Hospital of Oulu, Paediatric Haematology and Oncology

location_facility: Klinikum Mutterhaus der Borromäerinnen gGmbH, Pädiatrische Abteilung

location_facility: Dipartimento Pediatrico degli OO.RR. di Bergamo

location_facility: Klinikum Kassel Gesundheit Nordhessen Holding AG, Klinik für pädiatrische Hämatologie und Onkologie

location_facility: Unité d'hémato-immuno-oncologie pédiatrique. Centre Hospitalier Universitaire niveau 1 - bâtiment FEH

location_facility: Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck, Universitätsklinik für Pädiatrie I

location_facility: Divisione di Pediatria- Ospedale "Casa Sollievo della Sofferenza"

location_facility: service d'oncologie pédiatrique, hopital Félix Guyon

location_facility: Dip. Scienze Pediatriche e dell'Adolescenza Ospedale Infantile Regina Margherita

location_facility: Instituto Português de Oncologia - Francisco Gentil - Porto

location_facility: Dipartimento Biomedicina Età Evolutiva- U.O. Pediatrica I Policlinico

location_facility: Barnonkologiska avdelningen, Barn 3, Norrlands Universitetssjukhus

location_facility: CHUV - Centre Hospitalier Universitaire Vaudois

location_facility: UAM Hématologie et Oncologie Pédiatrique, CHU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: Istituto di Clinica Pediatrica- Ospedale Regionale Microcitemie

location_facility: U.O. di Ematologia, Oncologia e Trapianto-Azienda Policlinico di Modena

location_facility: University Hospital Gent Pediatrische hemato-oncologie

location_facility: Oncoematologia Pediatrica IRCCS, Policlinico San Matteo Piazzale Golgi

location_facility: Universitätsklinik Tübingen, Klinik für Kinderheilkunde und Jugendmedizin, Päd. Hämatologie / Onkologie

location_facility: Department of Pediatric Hematology and Oncology, Nicolaus Copernicus University

location_facility: Universitätskliniken für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie, Geb. 9

location_facility: Department of Pediatric Oncology and Hematology, Provincial Specialist Children's Hospital

location_facility: Unité Onco- Hématologie Pédiatrique CHU Estaing 1 place Lucie-Aubrac

location_facility: Department of Pediatric Hematology and Oncology, Center of Pediatrics and Oncology in Chorzów

location_facility: Universitätsklinikum Gießen und Marburg, Standort Gießen, Zentrum für Kinderhämatologie und -onkologie

location_facility: Clinica Pediatrica, Centro Regionale Oncoematologia Pediatrica- Ospedale dei Bambini "G. Salesi"

location_facility: Klinikum Schwabing, Kinderklinik der TU Päd. Hämatologie / Onkologie, Station 24d

location_facility: Pôle Femme Mère Enfant ; Unité d'Hématologie/Oncologie pédiatrique, CHU Angers

location_facility: Service d'Hématologie - Oncologie pédiatrique CHU Limoges - Hôpital de la mère et de l'enfant

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Kepler Universitätsklinikum, Med Campus IV / Onkologie

location_facility: Department of pediatric hematology and oncology, Children´s University Hospital

location_facility: Zentrum für Kinderheilkunde der Universität Bonn, Abt. Päd. Hämatologie / Onkologie

location_facility: Universitätsklinikum Magdeburg A. ö. R., Kinderklinik, Päd. Hämatologie / Onkologie

location_facility: Children's Hospital at Hadassah, Ein Kerem Medical Center

location_facility: Service d'Hemato-Oncologie Pediatrique CHU Rouen

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Pôle mère enfant-Unité Hématologie - Oncologie pédiatrique - CHU Hôpital NORD

location_facility: Complejo Hospitalario Universitario Insular Materno Infantil

location_facility: Dept. of Pediatric Hematology and Oncology. University Hospital Motol and 2nd Medical School, Charles University

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Universitätsklinikum Schleswig Holstein Campus Kiel, Klinik für Allgemeine Pädiatrie, Päd. Onkologie / Hämatologie

location_facility: Schneider Children's hospital, Rabin Medical Center

location_facility: Helsinki University Hospital, Department of Pediatric Hematology and Oncology

location_facility: Department of Pediatric Oncology and Hematology, Center of Pediatrics in Kielce

location_facility: Hématologie Oncologie pédiatrique, CHRU Besançon

location_facility: U.O. Oncoematologia Pediatrica- Policlinico "G.B. Rossi"

location_facility: H.C. Andersens Children Hospital, Odense University Hospital

location_facility: Gemeinschaftskrankenhaus Herdecke, Kinder- und Jugendmedizin, Päd. Hämatologie / Onkologie

location_facility: Department of Pediatric Oncology/Hematology, Institute of Pediatrics, Medical College Jagiellonian University

location_facility: Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie

location_facility: Klinikum der Universität zu Köln, Klinik für Kinder- und Jugendmedizin, Abt. Kinderonkologie und -hämatologie

location_facility: Universitätskinderklinik Würzburg, Päd. Onkologie und Hämatologie

location_facility: Städtisches Klinikum Braunschweig gGmbH, Zentrum für Kinder- und Jugendmedizin

location_facility: Universitäts-Kinderklinik Heidelberg, Abt. Hämatologie / Onkologie

location_facility: Department of Pediatric Oncology, Hematology and Transplantology, Poznan University of Medical Sciences

lead_sponsor_type: academique


acronym: HOVON 156 AML

lead_sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland

summary: Activating mutations in the fms like tyrosine kinase 3 (FLT3) gene are observed in approximately 30% of patients with newly diagnosed acute myeloid leukemia (AML). Addition of the multitargeted kinase inhibitor midostaurin to standard chemotherapy prolongs event-free survival (EFS) and overall survival (OS) in patients with a FLT3 mutation. Gilteritinib is a more potent and more specific inhibitor of mutant FLT3 in comparison to midostaurin and has shown promising clinical activity in AML.

sponsor_collaborators: Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)

sponsor_collaborators: Astellas Pharma Global Development, Inc.

location_facility:
DE-Berlin-CAMPUSVIRCHOW
BE-Brussel-BORDET
FR-Rennes cedex 9-CHURENNES
SE-Stockholm-KAROLINSKAHUDDINGE
AU-Melbourne-MONASH
IE-Dublin 4-SVUH
CH-Basel-USB
FR-Nice-CAL
ES-Palma-HSLL
NO-Bergen-HELSEBERGEN
FI-Helsinki-HUS
DE-Oldenburg-KLINIKUMOLDENBURG
DE-Braunschweig-KLINIKUMBRAUNSCHWEIG
AU-Brisbane-PAH
DE-Ulm-UNIKLINKULM
LU-Luxembourg-CHL
NL-Breda-AMPHIA
DE-Frankfurt-KLINIKUMFRANKFURT
DE-Hamburg-ASKLEPIOSSTGEORG
NL-Den Haag-HAGA
NL-Nijmegen-RADBOUDUMC
ES-Barcelona-VHEBRON
FR-Clamart-HIAPERCY
DE-Magdeburg-OVGU
AU-Perth-RPH
BE-Yvoir-MONTGODINNE
DE-Offenburg-ORTENAUKLINIKUM
NO-Oslo-OSLOUH
NL-Maastricht-MUMC
DE-Düsseldorf-MEDUNIDUESSELDORF
DE-Wuppertal-HELIOSGESUNDHEIT
NO-Tromsø-NORTHNOORWEGEN
DE-Berlin-VIVANTESURBAN
ES-Tarragona-JOAN
FR-Tours cedex-BRETONNEAU
CH-Luzern-LUKS
FR-Rouen cedex-BECQUEREL
NL-Dordrecht-ASZ
NL-Delft-RDGG
FR-Montpellier-STELOI
DE-Bonn-UNIBONN
DE-Lemgo-KLINIKUMLIPPE
IE-Cork-CUH
FR-Lyon Pierre Benite cedex-LYONSUD
SE-Uppsala-UPPSALAUH
DE-Luedenscheid-KLINIKUMLUEDENSCHEID
AU-Adelaide-RAH
DE-Aschaffenburg-KLINIKUMAB
CH-Zürich-USZ
BE-Roeselare-AZDELTA
AT-Innsbruck-IMED
ES-Lleida-ICSVILANOVA
NL-Amersfoort-MEANDERMC
FR-Reims-CHREIMS
DE-Esslingen-KLINIKUMESSLINGEN
DE-Saarbrücken-CARITASKLINIKUM
FR-Angers-CHUANGERS
FR-Nice-LARCHET
DE-Hamm-EVKHAMM
BE-Brugge-AZBRUGGE
NL-Rotterdam-ERASMUSMC
NL-Utrecht-UMCUTRECHT
NL-Leeuwarden-MCL
DE-Tübingen-MEDUNITUEBINGEN
DE-Meschede-HOCHSAUERLAND
IE-Co. Limerick-UHL
FR-Grenoble cedex 9-CHUGRENOBLE
NL-Den Bosch-JBZ
DE-Berlin-CAMPUSMITTE
DE-Hannover-MHHANNOVER
DE-Dortmund-JOHODORTMUND
AU-Camperdown-RPA
DE-Ludwigshafen-KLILU
ES-Barcelona-CLINICUB
DE-Heilbronn-SLK
AU-Perth-FSH
DE-Stuttgart-DIAKSTUTTGART
IE-Dublin 9-BEAUMONT
AU-Brisbane-RBWH
BE-Gent-UZGENT
DE-Passau-KLINIKUMPASSAU
NL-Enschede-MST
FR-Vandoeuvre Les Nancy-CHRUNANCY
DE-Bremen-KBM
FR-Pessac Cedex-CHUBORDEAUX
BE-Antwerpen-ZNASTUIVENBERG
FR-Amiens-CHUAMIENS
DE-Berlin-CAMPUSBENFRANKLIN
FR-Argenteuil-CHARGENTEUIL
DE-München-IRZTUM
ES-Barcelona-ICODURANREYNALS
DE-Minden-MUEHLENKREISKLINKEN
AU-Gosford NSW-GOSFORDHOSPITAL
DE-Villingen-Schwenningen-SBKVS
BE-Bruxelles-STLUC
DE-Hamburg-ASKLEPIOS
DE-Herne-MARIENHOSPITALHERNE
NL-Nieuwegein-ANTONIUS
DE-Darmstadt-KLINIKUMDARMSTADT
NL-Eindhoven-MAXIMAMC
CH-Bern-INSEL
DE-Essen-KEM
DE-Bad Saarow-HELIOSBADSAAROW
AU-Melbourne-AUSTIN
FR-Toulouse-CHUTOULOUSE
DE-Goch-KKLE
FR-Besançon Cedex-JEANMINJOZ
ES-Barcelona-SANTPAU
DE-Kaiserslautern-WESTPFALZ
DE-Homburg-UNIKLINIKSAARLAND
FR-Marseille-IPC
FR-Lyon-LEONBERARD
IE-Dublin 24-TUH
DE-Trier-MUTTERHAUS
FR-Clermont-Ferrand-ESTAING
ES-Madrid-CSGREGORIOMARANON
CH-Bellinzona-IOSI
DE-Karlsruhe-KLINIKUMKARLSRUHE
NL-Amsterdam-VUMC
FR-Lille-CHULILLE
DE-Stuttgart-KLINIKUMSTUTTGART
DE-Lübeck-UKSHLUBECK
FR-Villejuif-GUSTAVEROUSSY
BE-Haine-Saint-Paul-JOLIMONT
FI-Tampere-TAYS
NO-Stavanger-HELSESTAVANGER
BE-Liege-CHRCITADELLE
NL-Zwolle-ISALA
BE-Hasselt-VIRGAJESSE
DE-Regensburg-UKR
ES-Palma-SSIB
AT-Graz-MEDUNIGRAZ
NL-Amsterdam-OLVG
ES-Valencia-MALVARROSA
AU-Hobart TAS-RHOBART
AU-Sydney-WSAH
DE-Hamburg-UKE
NL-Leiden-LUMC
AU-Melbourne-SVHM
DE-Giessen-UKGM
FR-Saint-Priest-en-Jarez-ICLOIRE
BE-Mons-AMBROISE
NO-Trondheim-STOLAV
CH-Fribourg-HFR
AU-Sydney-CONCORD
IE-Galway-UHGALWAY
AU-Douglas-TOWNSVILLE
AU-Adelaide-FLINDERS
AT-Salzburg-SALK
AU-Melbourne-RMELBOURNE
IE-Dublin 7-MATER
AT-Linz-KEPLER
AU-Melbourne-BOXHILL
CH-St. Gallen-KSSG
ES-Barcelona-PARCDESALUTMAR
CH-Lausanne-CHUV
AU-Perth-SCGH
ES-Barcelona-GERMANTRIALS
NL-Amsterdam-AMC
St George Hospital
DE-Flensburg-MALTESER
CH-Geneve (14)-HCUGE
NL-Arnhem-RIJNSTATE
NL-Groningen-UMCG
ES-Barcelona-MUTUATERRASSA
DE-Greifswald-UNIGREIFSWALD
AT-Vienna-HANUSCH
IE-Dublin 8-STJAMES
FR-Limoges-CHULIMOGES
AU-Melbourne-ALFRED
DE-Mainz-UNIMEDIZINMAINZ
FR-Strasbourg cedex-HAUTEPIERRE
AT-Linz-ORDENSKLINIKUM
BE-Leuven-UZLEUVEN
ES-Girona-ICSTRUETA
CH-Aarau-KSA
DE-Bochum-RUB
FR-Nantes-CHUNANTES
AU-Sydney-NEPEAN
BE-Liege-CHULIEGE
AU-Sydney-RNSH
LT-Vilnius-SANTA
DE-Hanau-KLINIKUMHANAU
DE-Berlin-VIVANTESNEUKOLLN
AU-Geelong VIC-BARWONHEALTH
FR-Bobigny-AVICENNE
SE-Lund-SUH
FR-Le Chesnay cedex-CHVERSAILLES
FR-Bayonne-CHCOTEBASQUE
FR-Paris cedex 15-NECKER
DE-Hannover-SILOAHKRH
AU-Waratah-CALVARYMATER
FR-Poitiers-CHUPOITERS
FR-Paris cedex 10-SAINTLOUIS

title: A Phase 3, Multicenter, Open-label, Randomized, Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes With Excess Blasts-2 (MDS-EB2) With FLT3 Mutations Eligible for Intensive Chemotherapy (HOVON 156 AML / AMLSG 28-18)

type: Other Identifier

location_country: Finland Germany Ireland Lithuania Norway Australia Sweden Netherlands Austria Belgium Switzerland Spain Luxembourg France


title: A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis

summary: A phase 2b study to evaluate the long-term efficacy and safety study of ABX464 50mg as maintenance therapy in patients with moderate to severe Ulcerative Colitis.

status: Unknown status

ReferenceCitation: Vermeire S, Sands BE, Tilg H, Tulassay Z, Kempinski R, Danese S, Bunganic I, Nitcheu J, Santo J, Scherrer D, Biguenet S, Ehrlich HJ, Steens JM, Gineste P, Sandborn WJ. ABX464 (obefazimod) for moderate-to-severe, active ulcerative colitis: a phase 2b, double-blind, randomised, placebo-controlled induction trial and 48 week, open-label extension. Lancet Gastroenterol Hepatol. 2022 Nov;7(11):1024-1035. doi: 10.1016/S2468-1253(22)00233-3. Epub 2022 Sep 6.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Abivax S.A.

location_country:
Germany
Belarus
Italy
Poland
Slovenia
Slovakia
Hungary
United Kingdom
Austria
Belgium
Spain
Czechia
Canada
Ukraine
Serbia
France

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: CI City Clinical Hospital #6 Dept of Gastroenterology

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

location_facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: Vitebsk regoinal clinical specialized center

location_facility: Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU

location_facility: Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU

location_facility: Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: CNE Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: University Hospitals Leuven - campus Gasthuisberg

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

status_simplified: Unknown


title: Multi-Country Prospective ObserVAtionaL, Cohort Study of Patients With Moderate to Severe Chronic PlaqUE Psoriasis (VALUE)

acronym: VALUE

summary: This study will assess the use of risankizumab in adult patients with moderate to severe chronic plaque psoriasis and compare risankizumab to other commonly used biologics.

lead_sponsor: AbbVie

location_country:
Germany
Ireland
Poland
Argentina
Australia
Japan
Czechia
Canada
France
Colombia
Hungary
Switzerland
Romania
Italy
United Kingdom
Netherlands
Austria
Mexico
United Arab Emirates
Saudi Arabia
Spain

location_facility: Hopital de la Cavale Blanche /ID# 216495

location_facility: Hamilton Health Sciences Corporation /ID# 214053

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 215972

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 222025

location_facility: Kingston Hospital NHS Foundation Trust /ID# 230856

location_facility: Centro Especializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiova /ID# 216979

location_facility: The Jikei University Hospital /ID# 213393

location_facility: Centre de Recherche St-Louis /ID# 216325

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 216663

location_facility: CHU Grenoble - Hopital Michallon /ID# 218437

location_facility: Haut. Venen. Allergie. Zentrum Brunnehof /ID# 212742

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 215479

location_facility: Labderm S.C. Beata Bergler-Czop, Barbara Sido-Bergler /Id# 225447

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 218558

location_facility: Takamatsu Red Cross Hospital /ID# 241120

location_facility: Brinkmann & Partner, Gladbeck, /ID# 214247

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 212960

location_facility: Hôpital d'Instruction des Armées Sainte-Anne /ID# 218888

location_facility: Nagoya City University Hospital /ID# 213363

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 225084

location_facility: The Dudley Group NHS Foundation Trust /ID# 215839

location_facility: Università degli Studi di Firenze /ID# 221383

location_facility: Grupo Clinico Catei Sociedad Civil /Id# 216978

location_facility: IRCCS Policlinico San Donato /ID# 222002

location_facility: CHU Amiens-Picardie Site Sud /ID# 216170

location_facility: Emiliano Baccarini Priv Practice /ID# 218581

location_facility: Angela Montgomery Medicine Professional Corporation /ID# 213615

location_facility: Azienda Ospedaliera di Padova /ID# 221299

location_facility: University of the Ryukyus Hospital /ID# 213394

location_facility: Medizinische Universitaet Wien /ID# 216138

location_facility: Al-Mohammedi Medicine Professional Corporation /ID# 215408

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 212959

location_facility: Hôpital d'instruction des armées Bégin /ID# 216167

location_facility: South Eastern Health and Social Care Trust /ID# 215477

location_facility: KKing Abdulaziz Medical City- National Guard Hospital /ID# 224354

location_facility: Hospital Universitario de Getafe /ID# 225086

location_facility: Praxis Dres. Kaspari /Schenck /ID# 213649

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 213670

location_facility: Hospital Universitario Miguel Servet /ID# 225080

location_facility: Ospedale Policlinico San Martino /ID# 218844

location_facility: Frimley Health NHS Foundation Trust /ID# 215976

location_facility: South Infirmary Victoria University Hospital /ID# 213001

location_facility: Hospital Universitario Virgen de Valme /ID# 225104

location_facility: King Saud University Med City /ID# 219065

location_facility: Hospital Universitario Austral /ID# 217540

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 218555

location_facility: Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 218845

location_facility: Gemeinschaftspraxis Rietkoetter und Jablonka /ID# 213482

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 222464

location_facility: Fakultni nemocnice Kralovske Vinohrady /ID# 233184

location_facility: Asahikawa Medical University Hospital /ID# 213409

location_facility: Sanatorium profesora Arenbergera /ID# 215489

location_facility: Nippon Medical School Hospital /ID# 213391

location_facility: Jichi Medical University Hospital /ID# 213403

location_facility: Hospital Universitario Ramon y Cajal /ID# 225093

location_facility: Hospital Universitario 12 de Octubre /ID# 238474

location_facility: Hospital Virgen de la Concha /ID# 233285

location_facility: Praxis Dres. Ziegler & Partner /ID# 213647

location_facility: Waldhotel Health & Medical Excellence /Id# 212743

location_facility: Dermatologie Quist - BAG Dres. Quist PartG /ID# 214249

location_facility: Kingston Hospital NHS Foundation Trust /ID# 215973

location_facility: Centro Dermatologico Del Country S de Rl de Cv /Id# 225460

location_facility: The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 215476

location_facility: Radboud Universitair Medisch Centrum /ID# 213592

location_facility: Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 213389

location_facility: CEDIC Centro de Investigaciones Clinicas /ID# 217184

location_facility: Sandwell and West Birmingham Hospitals NHS Trust /ID# 249294

location_facility: SimcoDerm Medical and Surgical Dermatology Center /ID# 213081

location_facility: Fakultni nemocnice Hradec Kralove /ID# 222670

location_facility: Dr Maksym Breslavets Medicine Professional Corporation /ID# 213338

location_facility: DermaKiel Allergie und Haut Centrum /ID# 213977

location_facility: Markusovszky Egyetemi Oktatokorhaz /ID# 212961

location_facility: Kansai Medical University Hospital /ID# 213388

location_facility: IRCCS Istituto Ortopedico Galeazzi /ID# 218867

location_facility: Private Office Cristina Echeverria /ID# 222082

location_facility: Breitsprecher, Osnabrueck, DE /ID# 213672

location_facility: Hospital Universitario de Puerto Real /ID# 225103

location_facility: Hospital Universitario Principe de Asturias /ID# 225085

location_facility: Hospital Universitario de Bajadoz /ID# 225091

location_facility: Hospital General Universitario Gregorio Maranon /ID# 231664

location_facility: Centro Dermatológico Federico Lleras Acosta E.S.E /ID# 222686

location_facility: Dlugosz-Wolf, Luedenscheid, DE /ID# 222000

location_facility: Kingsway Dermatology & Aesthetics /ID# 217616

location_facility: Nemocnice Ceske Budejovice a.s. /ID# 216310

location_facility: Farheen Mussani Medicine Professional Corporation /ID# 213811

location_facility: Duplicate_Praxis Dres. Kloss/Peterburgskiy /ID# 213960

location_facility: Northampton General Hospital /ID# 249297

location_facility: Hospital Universitario Virgen de las Nieves /ID# 225107

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 231663

location_facility: NewLab Clinical Research Inc. /ID# 213521

location_facility: Hautarztpraxis Dr. med. Matthias Hoffmann /ID# 213444

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 225415

location_facility: Hospital Universitario del Sureste /ID# 226561

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 218720

location_facility: CH Bigorre - Site de la Gespe /ID# 218563

location_facility: Universitaetsklinikum Magdeburg /ID# 215080

location_facility: Neki Servicios Medicos Profesionales S D Rl de Cv /Id# 216977

location_facility: ASST Spedali civili di Brescia /ID# 218717

location_facility: Psoriahue Med Interdisciplinar /ID# 217182

location_facility: Hospital Universitario Severo Ochoa /ID# 225087

location_facility: University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 213507

location_facility: Sociedad de Cirugía de Bogotá- Hospital de San José /ID# 222683

location_facility: Fundacion hospitalaria San Vicente de Paul /ID# 222680

location_facility: Takamatsu Red Cross Hospital /ID# 222875

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 225076

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 225446

location_facility: RM Pharma Specialists S.A de C.V. /ID# 225458

location_facility: Praxis Dr. med. Alexander Zich /ID# 245751

location_facility: Gemeinschaftspraxis Dres. Anika Hünermund/Mario Pawlak /ID# 213113

location_facility: York and Scarborough Teaching Hospitals NHS Foundation Trust /ID# 227940

location_facility: Instituto de Neumonología y Dermatología /ID# 217429

location_facility: Praxis fuer Innere Medizin/Rheumatologie /ID# 213653

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi /Id# 214335

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 218808

location_facility: Inselspital, Universitätsspital Bern /ID# 212741

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 219031

location_facility: CMS3 Company for Medical Study /ID# 213676

location_facility: CHR Metz-Thionville - Hopital Bel-Air /ID# 225691

location_facility: Cwm Taf Morgannwg University Health Board /ID# 215974

location_facility: University Hospital Limerick /ID# 216997

location_facility: Praxis Dr. Konstantin Ertner /ID# 213640

location_facility: Studiengesellschaft an der Hase GbR Praxis Weyergraf/Frick/Heiber /ID# 214466

location_facility: Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 224743

location_facility: Clinica Los Arcos Iztapalapa /Id# 216982

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 218718

location_facility: Matsuyama Red Cross Hospital /ID# 224745

location_facility: Hospital Alvaro Cunqueiro CHUVI /ID# 225077

location_facility: Universitatsklinikum Mannheim /ID# 214569

location_facility: Universitaetsklinikum Erlangen /ID# 213669

location_facility: CH Pontoise - Hopital René Dubos /ID# 216169

location_facility: Hospital Universitario de Salamanca /ID# 225078

location_facility: Fujita Health University Hospital /ID# 224742

location_facility: Hospital Santa María del Rosell /ID# 225100

location_facility: Azienda Ospedaliera Universitaria Mater Domini- Campus Salvatore Venuta /ID# 218902

location_facility: Northern Care Alliance NHS Group /ID# 218589

location_facility: Centre Hospitalier de CHAMBERY /ID# 217572

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 218546

location_facility: Hospital General de Mostoles /ID# 225088

location_facility: Fundacion Hospital Universidad del Norte /ID# 223428

location_facility: Caja de Compensación Familiar Cafam, Sede Centro de Atención En Salud Cafam Flor /ID# 222660

location_facility: CHU de Rennes - PONTCHAILLOU /ID# 218248

location_facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 216245

location_facility: Praxis Dres. Bornemann/Reinerth /ID# 213368

location_facility: Hospital Universitario Lucus Augusti /ID# 233282

location_facility: Dr Melinda Gooderham Medicine Professional Corporation /ID# 212133

location_facility: CH Annecy Genevois Site Annecy /ID# 225786

location_facility: Tokyo Medical University Hospital /ID# 217125

location_facility: Presidio Ospedaliero San Salvatore /ID# 218719

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 216140

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 212958

location_facility: Weihe/Stavermann, Berlin, DE /ID# 214550

location_facility: Ospedale Fiorini di Terracina /ID# 218557

location_facility: Tallaght University Hospital /ID# 212999

location_facility: University Hospital Kyoto Prefectural University of Medicine /ID# 213396

location_facility: Lima's Excellence in Allergy and Dermatology Research Inc /ID# 231973

location_facility: Hospital Universitari Son Espases /ID# 233286

location_facility: St.Luke's International Hospital /ID# 213392

location_facility: Imperial College Healthcare NHS Trust /ID# 215978

location_facility: Azienda Ospedaliera di Perugia /ID# 219033

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219032


title: Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease

acronym: TRACK

summary:
The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled trial. TRACK is a global trial and will be conducted in renal units that provide comprehensive CKD care. Approximately 2000 participants will be recruited.

The TRACK trial will assess a strategy of administering low dose rivaroxaban to reduce the risk of major adverse cardiac event (MACE) in people with Chronic Kidney Disease (CKD) stages 4 or 5 or dialysis-dependent kidney failure, and elevated cardiovascular (CV) risk (marked by a history of CAD or PAD, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years).

ipd_sharing_description:
Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences.

Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices), may be shared with Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

lead_sponsor: The George Institute

collaborators: Centre Hospitalier Régional Universitaire de Nancy

collaborators: King Abdullah International Medical Research Center

location_country:
India
Singapore
Australia
Tunisia
Saudi Arabia
Malaysia
Taiwan
Canada
France

location_facility: All India Institute Of Medical Sciences, Raipur

location_facility: Postgraduate Institute of Medical Education and Research, Chandigarh

location_facility: Institute of Post-Graduate Medical Education and Research

location_facility: Chang Gung Memorial Hospital, Linkou Medical Center

location_facility: Kasturba Medical College and Hospital, Manipal

location_facility: Hôpital de la Maison Blanche, (CHU Reims)

location_facility: KG Hospital, K.Govindaswamy Naidu Medical Trust

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: All India Institute of Medical Sciences, Bathinda

location_facility: CH Boulogne-sur-Mer, (CH Boulogne-sur-Mer)

location_facility: Aykai Super Speciality Hospital, Ludhiana

location_facility: Nizam's Institute of Medical Sciences, Hyderabad

location_facility: ialysis Centre - King Abdul Aziz Medical City (KAMC)

location_facility: Hôpital de la Cavale Blanche, (CHU Brest)


title: Biomarker Study to Identify Subjects With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations

summary: The purpose of this non-interventional study is to identify participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations through molecular testing of their archival tumor tissue.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Italy
Israel
Argentina
United Kingdom
Japan
Brazil
Belgium
United States
Spain
Turkey
Ukraine
Russian Federation
France

location_facility: Investigaciones Clinico Moleculares (ICM)

location_facility: Consultants in Medical Oncology and Hematology, P.C. - Abington

location_facility: Adnan Menderes University Training and Research Hospital

location_facility: Hospital SS Annunziata - University G.D'Annunzio

location_facility: Instituto Sensumed de Ensino e Pesquisa Ruy França - ISENP

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: SUBARU Health Insurance Society Ota Memorial Hospital

location_facility: Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: National Hospital Organization Osaka National Hospital

location_facility: IRPCC - Instituto Ribeiraopretano de Combate ao Cancer

location_facility: SCMI Santa Casa de Misericórdia de Itabuna

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Az. USL 12 di Viareggio Ospedale Versilia

location_facility: Polo Ospedaliero Unico Integrato- Presidio S.Camillo De Lellis Di Rieti

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Tomsk National Research Medical Center of the Russian Academy of Sciences

location_facility: Municipal Non-profit enterprise 'Bukovinian clinical oncology center'

location_facility: Canakkale Onsekiz Mart University Health Practices and Research Hospital

location_facility: Centre Hospitalier Eure-Seine - Hopitaux d'Evreux - Vernon

location_facility: Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council

location_facility: CEDOES - Centro de Pesquisa Clinica e Diagnostico do Espirito Santo Ltda.

location_facility: ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Azienda Ulss 6 Euganea- Ospedale Di Camposampiero

location_facility: Azienda Ulss 8 Berica- Ospedale Di Vicenza

location_facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

location_facility: Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas

location_facility: Kartal Dr. Lutfi Kirdar Egitim ve Arastirma Hastanesi

location_facility: FSBI A.V. Vishnevsky National Medical Research Center of Surgery of the MoH RF

location_facility: SHI Sverdlovsk Regional Clinical Hospital #1

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: National Hospital Organization Mito Medical Center

location_facility: Oncology Medical Clinics AV Medical group

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: Texas Oncology-Midland Allison Cancer Center

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Izmir Katip Celebi University Ataturk Training and Research Hospital

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Yaroslavl Regional Clinical Oncology Hospital

location_facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Azienda Ospedaliera Ospedale San Carlo Borromeo

location_facility: Azienda Ospedaliera "Ospedale Civile" di Vimercate - Ospedal

location_facility: Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

location_facility: Cepeville - Centro de Hematologia e Oncologia

location_facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

location_facility: National Hospital Organization Osaka Minami Medical Center

location_facility: Associacao Feminina de Educacao e Combate ao Cancer - Hospital Santa Rita de Cassia

location_facility: Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'

location_facility: Necmettin Erbakan University Meram Medical Faculty

location_facility: Nucleo de Ensino e Pesquisa do Instituto Mario Penna

location_facility: Ospedale Buccheri La Ferla Fatebenefratelli

location_facility: State Budgetary Healthcare Institution Inter-regional Multi-specialty Hospital

location_facility: Ensino e Terapia de Inovacao Clinica AMO - Etica