title: Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin's lymphoma.

ReferenceCitation: Pettengell R, Schmitz N, Gisselbrecht C, Smith G, Patton WN, Metzner B, Caballero D, Tilly H, Walewski JA, Bence-Bruckler I, To B, Geisler CH, Schots R, Kimby E, Taverna CJ, Kozák T, Dreger P, Uddin R, Ruiz de Elvira C, Goldstone AH. Rituximab purging and/or maintenance in patients undergoing autologous transplantation for relapsed follicular lymphoma: a prospective randomized trial from the lymphoma working party of the European group for blood and marrow transplantation. J Clin Oncol. 2013 May 1;31(13):1624-30. doi: 10.1200/JCO.2012.47.1862. Epub 2013 Apr 1.

lead_sponsor: EBMT Solid Tumors Working Party

location_country:
Denmark
Poland
Portugal
Spain
United Kingdom
Austria
Australia
New Zealand
Canada
Czech Republic
Switzerland
Sweden
France
Israel
Turkey
Belgium
Germany

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Clinical Trials and Research Unit of the University of Leeds

location_facility: Royal Liverpool and Broadgreen Hospitals NHS Trust

location_facility: Singleton Hospital of the Swansea NHS Trust

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Southampton University Hospital NHS Trust

location_facility: Karolinska University Hospital - Huddinge

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Ottawa Hospital Regional Cancer Centre - General Campus

location_facility: Westmead Institute for Cancer Research at Westmead Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: Centre for Cancer Research and Cell Biology at Belfast City Hospital

location_facility: Royal Marsden NHS Foundation Trust - Surrey

location_facility: Rotherham District General Hospital - NHS Trust

location_facility: Hospital Universitario Central de Asturias

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Rigshospitalet - Copenhagen University Hospital


title: Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have relapsed or refractory acute lymphocytic leukemia.

status: Terminated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: France Portugal Belgium

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: Centre Hospitalier Regional de la Citadelle

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: IDA VS MTZ IN INDUCTION AND INTENSIFICATION TREATMENT OF AML OR MDS IN CHILDREN, A PHASE III RANDOMIZED STUDY

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute myeloid leukemia or myelodysplastic syndrome.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or myelodysplastic syndrome.

status: Completed

design_allocation: Randomized

ReferenceType: result

ReferenceCitation: Brunet AS, Ploton C, Galambrun C, Pondarré C, Pages MP, Bleyzac N, Freydière AM, Barbé G, Bertrand Y. Low incidence of sepsis due to viridans streptococci in a ten-year retrospective study of pediatric acute myeloid leukemia. Pediatr Blood Cancer. 2006 Nov;47(6):765-72.

ReferenceCitation: Entz-Werle N, Suciu S, van der Werff ten Bosch J, Vilmer E, Bertrand Y, Benoit Y, Margueritte G, Plouvier E, Boutard P, Vandecruys E, Ferster A, Lutz P, Uyttebroeck A, Hoyoux C, Thyss A, Rialland X, Norton L, Pages MP, Philippe N, Otten J, Behar C; EORTC Children Leukemia Group. Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogeneic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group report. Leukemia. 2005 Dec;19(12):2072-81.

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

intervention_type: Radiation

status_simplified: Completed


type: EudraCT Number

type: Other Identifier

title: A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

acronym: DUET-CD

summary: The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Argentina
India
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
Estonia
New Zealand
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility: Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: GIRI Gastrointestinal Research Institute

location_facility: Japan Community Health Care Organization Osaka Hospital

location_facility: P.D. Hinduja National Hospital and - Medical Research Center

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: Hospital Clinico Regional Dr. Guillermo Grant Benavente

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: University of Washington Digestive Disease Center

location_facility: Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum

location_facility: Impar Servicos Hospitalares S/A - Hospital Brasília

location_facility: Gastroenterology and Internal Medicine Research Institute (GIRI)

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Ospedale Molinette, AO Città della Salute e della Scienza di

location_facility: Centre hospitalier universitaire de St Etienne

location_facility: General Hospital of Athens 'Ippokrateion'

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: Hadassah Hebrew University Medical Center

location_facility: Clinical Research Centre University of Cape Town

location_facility: Gastroenterology Associates of Orangeburg, SC

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Centrum Zdrowia Matki, Dziecka i Młodzieży

location_facility: Texas Gastroenterology Associates - Research

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Seoul National University Bundang Hospital

location_facility: Vilnius University Hospital Santaros Klinikos, Public Institution

location_facility: National Hospital Organization Hirosaki General Medical Center

location_facility: Special hospital for Internal diseases, Oncomed system

location_facility: McGill University - Health Centre - Montreal General Hospital

location_facility: Gastroenterology Department ENDOMED, s.r.o.

location_facility: Clinic for hematology, Clinical Center Bezanijska Kosa

location_facility: Hospital das Clinicas - Universidade Federal de Pernambuco

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: National Center for Global Health and Medicine

location_facility: Oslo University Hospital HF Ullevål sykehus

location_facility: LSUHSC Shreveport Feist-Weiller Cancer Center

location_facility: Complejo Hospitalario Dr. Sotero del Rio.

location_facility: Ospedale Specializzato in Gastroenterologia Saverio de Bellis

location_facility: Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Hopital Ambroise Paré - APHP Hôpitaux Universitaires Paris I - Oncologie Thoracique

location_facility: CTC North GmbH & Co. KG, Am Universitätsklinikum Hamburg-Eppendorf

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: The first affiliated hospital of suzhou University

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Huron Gastroenterology Associates Center for Digestive Care

location_facility: Herlev Hospital, University of Copenhagen

location_facility: South Eastern Health and Social Care Trust

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

location_facility: UW School of Medicine and Public Health - Office of Clinical Trials

location_facility: Centrum Opieki Zdrowotnej Orkan-med Stec-Michalska sj

location_facility: Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk

location_facility: Surat Institute of Digestive Sciences Hospitals

location_facility: NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Digestive Health Research of Southern California, LLC

location_facility: Institute for Digestive Health and Liver Disease

location_facility: Pracownia Endoskopowa Szpital Zakonu Bonifratrow sw. Jana Bozego w Lodzi sp. z o.o.

location_facility: Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria

location_facility: Second Affiliated Hospital, Harbin Medical University

location_facility: UFRJ-Hospital Universitário Clementino Fraga Filho

location_facility: The second Xiangya Hospital of Central South University

location_facility: University Hospitals Case Medical Center

location_facility: Marshall Health Clinical Research Center

location_facility: Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Indira Gandhi Institute of Medical Sciences

location_facility: Military Medical Academy, Clinic for Psychiatry

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Centro de Estudios Clínicos e Investigación Médica (CeCim)

location_facility: A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale

location_facility: University of Pennsylvania - Perelman School of Medicine

location_facility: Gastroenterology Clinic Of San Antonio P A

location_facility: Clinica de Investigacion en Reumatologia y Obesidad

location_facility: Siksha O Anusandhan University - Institute of Medical Scienc

location_facility: KL Ling Gastroenterology and Liver Clinic

location_facility: Semmelweis Egyetem I.Belgyogyaszati Klinika

location_facility: Gemeinschaftspraxis Mainz Mitte am Gesundheitscentrum Mainz

location_facility: Medizinisches Versorgungszentrum (MVZ) Dachau

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

location_facility: Xiangya Hospital Central South University

location_facility: Landeskrankenhaus Salzburg, Universitätsklinik f. Innere Medizin III

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Gastroenterologische Spezialpraxis - Berlin-Karlshorst

location_facility: Curiositas ad Sanum Studien und Beratungs GmBH

location_facility: Detska klinika Masarykovy nemocnice v Usti nad Labem

location_facility: Nanfang Hospital of Southern Medical Hospital

location_facility: Gastroenterolgy Associates of Central GA

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Synexus Polska Sp. z.o.o. Oddzial w Poznaniu

location_facility: Worthwhile Clinical Trials Lakeview Hospital

location_facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska

location_facility: Hunter Holmes McGuire Veterans Affairs Medical Center

location_facility: Multriprofile Hospital for Active Treatment Hristo Botev

location_facility: The Gordon & Leslie Diamond Health Care Center

location_facility: Hospital Das Clínicas Da Faculdade de Medicina de Ribeirão Preto

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva

location_facility: Tokyo Medical and Dental University Hospital

location_facility: University of Mississippi Medical Center

location_facility: Irmandade da Santa Casa da Misericórdia de Santos

location_facility: Sotiria General State Hospital of Chest Diseases

location_facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

location_facility: Hospital of the University of Occupational and Enviromental Health

location_facility: Centro Regiomontano de Estudios Clínicos Roma S.C.

location_facility: Centro Digestivo de Curitiba - Instituto de Pesquisa Clínica

location_facility: Mater Hospital Brisbane (Inflammatory Bowel Diseases)

location_facility: Medizinische Fakultät Mannheim der Universität Heidelberg

location_facility: General Hospital of Athens 'G. Gennimatas'

location_facility: Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Gastroenterologische Praxis Balsiger und Seibold

location_facility: Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: Mersin University Medical Faculty Hospital

intervention_type: Biological

status_simplified: Ongoing


title: A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination With Irinotecan Versus Investigator's Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer Patients (LAGOON Trial)

summary: Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of lurbinectedin with irinotecan (Group B) versus Investigator's Choice (topotecan or irinotecan) as control arm (Group C), in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.

lead_sponsor: PharmaMar

location_country:
Poland
Brazil
Romania
Spain
Italy
Georgia
Australia
United Kingdom
Canada
Switzerland
Hungary
United States
France
Belgium
Germany
Bulgaria

location_facility: Universita degli Studi della Campania Luigi Vanvitelli

location_facility: Mrukmed. Lekarz Beata Madej-Mruk i Partner. Sp.p

location_facility: Specialized hospital for active treatment of oncological diseases

location_facility: Hospital Universitario Fundación Jimenez Díaz

location_facility: Azienda Ospedaliera Univ. Senese Policlinico Le Scotte

location_facility: Centre Hospitalier Universitaire CHU De Limoges

location_facility: UPCO - Hospital de Clinicas de Porto Alegre

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital OOD Department of Medical Oncology

location_facility: Specjalistyczny Szpital Onkologiczny NU-MED sp. Z

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Veszprem Megyei Tudogyogyintezet Farkasgyepu

location_facility: Klinikum Kassel - Medizinische Klinik IV

location_facility: Oncologia Medica II Istituto Oncologico Veneto IRCCS

location_facility: Box Hill Hospital Eastern Health Clinical School

location_facility: Istituto Oncologico della Svizzera Italiana

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD Second Department of Medical Oncology

location_facility: Instituto Nacional de Cancer - Ministrio da Sade

location_facility: Szpitale Pomorskie Sp. z o.o., Oddzial Onkologii K

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: A.O. Santa Croce e Carle, Ospedale Carle

location_facility: Centre Hospitalier Chretien CHC - MontLegia

location_facility: Complex Oncology Center - Plovdiv EOOD, First Department of Medical Oncology and Oncological Diseases in Gastroenterology

location_facility: Institut Català d Oncologia (ICO) - Hospital Germans Trias i Pujol

location_facility: University Health Network - Princess Margaret Hospital

location_facility: ASL 3 Genovese Oncologia Medica Villa Scassi

location_facility: Centre Hospitalier Universitaire (CHU) Ambroise Pare

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

location_facility: Hospital Regional Universitario Málaga Hospital Civil

location_facility: Oncocentro-Centro de Oncologia do Parana

location_facility: Complexo Hospitalario Universitario De Vigo (CHUVI) - Hospital Xeral

location_facility: Specjalistyczna Praktyka Lekarska Slawomir Mandziuka

location_facility: Gosford Hospital GH - Central Coast Cancer Centre

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Szpital Specjalistyczny w Prabutach Sp. z o.o

location_facility: ASST Valtellina e Alto Lario Ospedale di Sondrio ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio

location_facility: Grand Hopital de Charleroi GHdC - Hopital Saint Joseph

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

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Algemeen Ziekenhuis AZ Klina - Borstkliniek

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia Ltda

location_facility: Hospital Clínico Universitario Lozano Bleza

location_facility: A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos - Hospital de Amor

location_facility: Centre Hospitalier Intercommunal de Creteil (CHIC)

location_facility: Azienda Ospedaliera Univ. Policlinico G Rodolico San Marco

location_facility: Complejo Hospitalario Materno-Insular de Gran Canaria

location_facility: Spital Thurgau - Kantonsspital Muensterlingen

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Staedtisches Klinikum München - Bogenhausen


title: Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Self-administered Subcutaneous Selatogrel for Prevention of All-cause Death and Treatment of Acute Myocardial Infarction in Subjects With a Recent History of Acute Myocardial Infarction

acronym: SOS-AMI

summary: This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

status: Enrolling by invitation

ReferenceType: background

ReferenceCitation: Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. Review.

ReferenceCitation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449.

ipd_sharing: No

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Serbia
Spain
Italy
United Kingdom
Lithuania
United States
Romania
Belgium
Czechia
Poland
Austria
Israel
Norway
Slovakia
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Ireland
Estonia
Finland
France
Netherlands

location_facility: Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center

location_facility: Universitätsspital Basel; Universitäres Herzzentrum

location_facility: Herzzentrum Dresden GmbH; Universitätsklinik an der Technischen Universität Dresden

location_facility: Institute of Cardiovascular Diseases Timisoara

location_facility: Centre Intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec

location_facility: Oslo University Hospital, Ullevål hospital

location_facility: Spital Clinic Judetean de Urgentia Cluj Napoca

location_facility: Cardiology Department - Santa Chiara Hospital

location_facility: Bremer Institut für Herz- und Kreislaufforschung

location_facility: Onze Lieve Vrouwe Gasthuis, locatie Oost

location_facility: Gottsegen György Országos Kardiovaszkuláris Intézet

location_facility: Department of Cardiology, Clinical Hospital Center Zemun

location_facility: Azienda Ospedaliero-Universitaria Policlinico ""G. Rodolico - San Marco

location_facility: CHI Institute for Research and Innovation

location_facility: Universitätsklinikum Freiburg; Universitäts-Herzzentrum Freiburg-Bad Krozingen

location_facility: CHU Caen · Unité Cardiologie et Pathologie Vasculaire

location_facility: Inselspital, Universitäatspital Bern, Universitäatklinik für Kardiologie

location_facility: Gesellschaft für Klinische Forschung mbH Ludwigshafen

location_facility: Betegápoló Irgalmasrend Budai Irgalmasrendi Kórház, Kardiológia

location_facility: Miedziowe Centrum Zdrowia Regionalny, Ośrodek Kardiologiczny, Pracownia Angiografii i Hemodynamiki

location_facility: Indiana University Health Ball Memorial Hospital

location_facility: Grandview Medical Center and Affinity Cardiovascular Specialists, LCC

location_facility: Central Slovak Institute of Cardiovascular Diseases

location_facility: Debreceni Egyetem Klinikai Központ Kardiológiai és Szívsebészeti Klinika

location_facility: Monument Health Clinical Research, Monument Health Rapid City Hospital Inc.

location_facility: Moses H. Cone Memorial Hospital Operation Corporation d/b/a Cone Health

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Studienzentrum Innere Med. II Kardiologie, Universitätsklinikum Regensburg

location_facility: Bon Secours St. Mary's Hospital of Richmond, LLC

location_facility: County Clinical Emergency Hospital Brasov

location_facility: Leviev Heart Center, Sheba Medical Center

location_facility: Universitätsklinikum Tübingen, Medizinische Klinik Innere Medizin III Kardiologie und Angiologie

location_facility: Sinai Hospital Baltimore, LifeBridge Health

location_facility: University of California San Diego Medical Center

location_facility: Institute of Cardiovascular Diseases, Vojvodina

location_facility: Wielospecjalistyczny Szpital SPZOZ w Nowej Soli

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kardiologii oraz Interwencji Sercowo-Naczyniowych

location_facility: University of Oklahoma Health Sciences Center

location_facility: Oddzial Kardiologii i intensywnej Terapii Kardiologicznej

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Invasive Cardiology Department, University Teaching Hospital in Białystok

location_facility: Lister Hospital East and North Hertfordshire NHS Trust

location_facility: University of Calgary Foothills Medical Centre

location_facility: Penn State Health Medical Group - Berks Cardiology

location_facility: Heart and Lung Center, Helsinki University Hospital

location_facility: University Hospital of Ferrara, Cardiology Unit

location_facility: Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika Kardiológia

location_facility: Hospital Alvaro Cunqueiro, Cardiovascular Unit

location_facility: Shaare Zedek Medical Center, Cardiology Department

location_facility: Górnośląskie Centrum Medyczne w Katowicach, III Oddział Kardiologii

location_facility: Hillel Yaffee Medical Center, Cardiology Department

location_facility: University Hospitals Cleveland Medical Center

location_facility: Jorvi Hospital, Helsinki University Hospital

location_facility: "SOD Cardiologia Interventistica Strutturale, AOU Careggi

location_facility: SCCS Zabrze I i II Oddział Kardiologii i Angiologii

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Northern Light Eastern Maine Medical Center

location_facility: Krankenhaus der Augustinerinnen Köln gGmbH

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

location_facility: Covenant Medical Group d/b/a Parkway Cardiology Associates

location_facility: Carol Davila University of Medicine and Pharmacy - Spitalul Universitar de Urgenta Elias

location_facility: County Clinical Emergency Hospital Tirgu Mures

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: University Clinical Center "Dr Dragisa Misovic Dedinje"

location_facility: Kliničko Bolnički Centar Bežanijska Kosa

location_facility: University of Florida Health Science Center at Jacksonville

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie, Oddział Kardiologii

location_facility: Columbia University Irving Medical Center

location_facility: Institutu Klinicke a Experimentalni Mediciny (IKEM) (Institute for Clinical and Experimental Medicine)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: MHAT South-West Hospital, Cardiology Department

location_facility: Nemocnice Pardubickeho kraje, a.s. - Pardubicka nemocnice

location_facility: Northeast Arkansas Charitable Foundation, Inc.- NEA Baptist Clinic

location_facility: Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii Uniwersyteckiego Centrum Klinicznego Warszawskiego Uniwersytetu Medycznego

location_facility: Amarillo Heart Clinical Research Institute Inc.

location_facility: Adventist Healthcare White Oak Medical Center

location_facility: North Tyneside General Hospital, Northumbria Healthcare

location_facility: Spitalul Judetean de Urgenta ""Dr. Constantin Opris" Baia Mare

location_facility: Kaplan Medical Center, Intensive Cardiac Care Unit

location_facility: Karl Landsteiner Institut für Kardiovaskuläre und Intensivmedizinische Forschung

location_facility: Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ II.sz. Belgyógyászati Klinika és Kardiológiai Központ

location_facility: Uniwersytecki Szpital Kliniczny we Wroclawiu

location_facility: CHUM - Centre hospitalier de l'Universite de Montreal"

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Dignity Health Mercy Gilbert Medical Center

intervention_type: Combination Product


title: A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

summary: The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.

location_country:
Spain
Italy
United Kingdom
Netherlands
Korea, Republic of
United States
France
Israel
Belgium
Germany

location_facility: UAMS Winthrop P. Rockefeller Cancer Institute

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University of California Irvine Medical Center

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Pusan National University Yangsan Hospital

location_facility: Sidney Kimmel Cancer Center - Jefferson Health

location_facility: Winship Cancer Institute Emory University

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Polyclinique de Limoges - Francois Chenieux

location_facility: Rabin Medical Center - Hasharon Hospital

location_facility: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

location_facility: Kyungpook National University Chilgok Hospital

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

location_facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

location_facility: West Roxbury Veterans Affairs Medical Center

location_facility: Centre Interuniversitaire Ambroise Pare - Ambroise Paré

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: ASL Napoli 2 Nord-SM delle Grazie Hospital

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Ospedale San Giuseppe Moscati di Avellino


type: Registry Identifier

title: A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE Plus)

summary:
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease.

Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance.

The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken.

Participants must have a study partner, who is willing to take part in the study.

Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.

A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
Finland
Korea, Republic of
France
Netherlands


title: A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE)

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Ireland
Finland
Korea, Republic of
France
Netherlands


title: A Phase 3, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration

acronym: GALE

summary: This is a phase 3, open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan (APL-2) in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who participated in Study APL2-103 (NCT03777332) or completed the treatment at Month 24 of either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600).

design_allocation: Non-Randomized

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Australia
Netherlands
Argentina
Canada
New Zealand
United States
France
Israel
Germany
Czechia

location_facility: Northern California Retina Vitreous Associates

location_facility: Retina Group of New England - New London

location_facility: Florida Eye Microsurgical Institute, Inc.

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Organizacion Medica de Investigacion (OMI)

location_facility: Charlotte Eye Ear Nose and Throat Associates, PS

location_facility: Northwestern Feinberg School of Medicine

location_facility: University of Utah - John A. Moran Center

location_facility: Byers Eye Institute, Stanford University

location_facility: Radboud university medical center Oogheelkunde

location_facility: Uni-medizin Gottingen Augenklinik 3.B1.261

location_facility: Retina Institute of California Medical Group

location_facility: Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky

location_facility: Vitreous Retina Macula Consultants of New York

location_facility: ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco

location_facility: Vision Research Center Eye Associates of NM

location_facility: Centre Hospitalier Intercommunal de Creteil


acronym: INDEPENDENCE

intervention_type: Other

title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK Inhibitor Therapy and Who Require Red Blood Cell Transfusions

lead_sponsor: Celgene

source: euctr

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Israel
Canada
Hungary
China
Germany
Greece
Ireland
Korea, Republic of
France

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Specjalistyczny Szpital im. dra Alfreda Sokolowskiego

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico

location_facility: Chonnam National University Hwasun Hospital

location_facility: Groupe Hospitalier Sud Hopital Haut Leveque USN

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: Chinese Academy of Medical Sciences & Peking Union Medical College

location_facility: First St Petersburg State Medical University na IP Pavlov

location_facility: Hospital Clinico Universitario de Valencia

location_facility: ICANS Institut de cancerologie Strasbourg Europe

location_facility: Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

location_facility: Ruijin Hospital Shanghai Jiaotong University

location_facility: Centre Hospitalier Peltzer - La Tourelle

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese

location_facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

location_facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: Tokyo Women's Medical University Hospital

location_facility: Hospital Universitari Germans Trias i Pujol ICO Badalona

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi

location_facility: Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: CTRC at The UT Health Science Center at San Antonio

location_facility: West Penn Allegheny Lupus Center of Excellence

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

location_facility: Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

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

location_facility: Seoul National University Bundang Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie

location_facility: Prince of Wales Hospital the Chinese University of Hong Kong

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

summary:
The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions.

The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period.


title: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

acronym: BRUIN CLL-321

summary: This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

lead_sponsor: Loxo Oncology, Inc.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Singapore
Canada
Switzerland
Hungary
China
Germany
Taiwan
Ireland
Korea, Republic of
France

location_facility: The Center for Cancer and Blood Disorders

location_facility: Arizona Oncology Associates, P.C. - HOPE

location_facility: Division of Hematology, Dept. of Internal Medicine, University Hospital Centre Zagreb

location_facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen

location_facility: ASST Spedali Civili - Università degli Studi

location_facility: Blood Institute of the Chinese Academy of Medical science

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C

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

location_facility: Carolina Blood and Cancer Care Associates

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Cancer Center Office of Clinical Research

location_facility: Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Kobe City Medical Center General Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Chu Nimes/Institut De Cancerologie Du Gard

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital

location_facility: Oncology Dispensary #2 of Krasnodar Region

location_facility: Mitchell Cancer Institute -University of South Alabama

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Clinica di Ematologia IOSI, Ospedale Bellinzona e Valli, Ente Ospedaliero Cantonale

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Complejo Hospitalario Universitario de Santiago de Compostel

location_facility: Southern Medical University Nanfang Hospital

location_facility: Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

location_facility: A.O.U. Policlinico G.Rodolico - S. Marco

location_facility: Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"

location_facility: Mercy Health-Paducah Medical Oncology and Hematology

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: CHU De Grenoble Hopital Albert Michallon

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

location_facility: Oncology-Hematology Associates of West Broward

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Cancer Specialists of North Florida -St Augustine

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Pole Regionalde Cancérologie(CHU de Poitiers)

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza, Oddział Hematologii Onkologicznej z Pododdziałem Transplantologii Klinicznej

location_facility: University of Kentucky Markey Cancer Center

location_facility: Tokai University Hospital- Isehara Campus

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina

location_facility: Academician I.P. Pavlov First St-Petersburg State Medical University

location_facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: The Catholic University of Korea-Seoul St. Mary's Hospital

location_facility: Hospital Universitario Infanta Leonor-INTERNAL MED

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii


title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤70 Years With Previously Untreated Non-GCB DLBCL

acronym: ESCALADE

summary: Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤70 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: Acerta Pharma BV

location_country:
Spain
Italy
Ukraine
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
India
Israel
Turkey
Mexico
Brazil
Canada
China
Germany
Taiwan
Korea, Republic of
France


title: A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory)

acronym: GREEN MEMORY

summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in mild to moderate Alzheimer's disease.

status: Suspended

ipd_sharing: Undecided

lead_sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

location_country:
Poland
Taiwan
Hong Kong
Australia
Canada
United States
France
China
Netherlands
Czechia

location_facility: University of Nebraska Medical Center-Hematology/Oncology Section

location_facility: Advanced Memory Research Institute of NJ, PC

location_facility: Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic

location_facility: Jacksonville Center for Clinical Research

location_facility: The Cognitive Research Center of New Jersey

location_facility: Austin Health - Heidelberg Repatriation Hospital

location_facility: St. Joseph's Hospital and Medical Center


title: Randomized Placebo-controlled Double-blinded Study of the Effect of TOTUM-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia

acronym: REVERSE-IT

summary: This clinical study aims to assess the efficacy of TOTUM-63, a mix of 5 plant extracts, consumed at the daily regimen of three times per day on glucose and lipid homeostasis in dysglycemic subjects. The hypothesis is that TOTUM-63, consumed 3 times per day, is superior to placebo for decrease of fasting plasma glucose (FPG) concentration after 24 weeks of consumption.

status: Active, not recruiting

primary_purpose: Prevention

lead_sponsor: Valbiotis

location_country: Poland Italy Hungary France Romania Germany Bulgaria

location_facility: Gemeinschaftspraxis Dr. Med C. Klein/J Minnich

location_facility: University Multiprofile Hospital for active treatment "Alexandrovska" EAD Clinic of Endocrinology and metabolic diseases

location_facility: Unité de Recherche Clinique en Immunologie Lyon Sud

location_facility: Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

location_facility: Diagnostic Consultative Center "ALEXANDROVSKA"

location_facility: Zentrum für Klinische Ernährung Stuttgart

location_facility: MHAT Sveta Karidad, First department of Internal Diseases

location_facility: Ambulatory for IPSOC in Endocrynology and Metabolic Diseases ENDO MED-CONSULT EOOD

location_facility: Diagnostic-consultative center 7 EOOD, Plovdiv

location_facility: Azienda Ospedaliera Universitaria "Mater Domini"

location_facility: Unité d'Investigation Clinique Biofortis Mérieux NutriSciences

location_facility: 4th Multiprofile Hospital for active treatment - EAD, Internal Diseases Departement

intervention_type: Dietary Supplement


title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis

acronym: HERCULES

summary:
Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS

Secondary Objective:

To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Norway
Canada
Hungary
China
Germany
Bulgaria
Denmark
Belarus
Greece
Finland
France
Netherlands

location_facility: Advanced Neuroscience Center-Site Number:8400035

location_facility: Center for Neurology and Spine-Site Number:8400089

location_facility: Neurology Center of San Antonio-Site Number:8400036

location_facility: Arcadia Neurology Center-Site Number:8400070

location_facility: Consultants In Neurology-Site Number:8400011

location_facility: Advanced Neurosciences Research-Site Number:8400025

location_facility: Neurology Clinic, PC-Site Number:8400087

location_facility: South Florida Neurology Associates-Site Number:8400029

location_facility: Aqualane Clinical Research-Site Number:8400027

location_facility: Minneapolis Clinic of Neurology-Site Number:8400051

location_facility: Mountain View Clinical Research-Site Number:8400024

location_facility: Axiom Clinical Research of Florida-Site Number:8400001

location_facility: Lou Ruvo Center for Brain Health-Site Number:8400117

location_facility: Jefferson Neurology Associates-Site Number:8400016

location_facility: University of Colorado-Site Number:8400012

location_facility: Meridian Clinical Research, LLC-Site Number:8400005

location_facility: University of Massachusetts-Site Number:8400014

location_facility: University of San Francisco, Sandler Neurosciences Center-Site Number:8400137

location_facility: University Hospitals CMC-Site Number:8400083

location_facility: Medical College of Wisconsin-Site Number:8400028

location_facility: Missouri Baptist Medical Center-Site Number:8400019

location_facility: University of New Mexico-Site Number:8400032

location_facility: Baylor College of Medicine-Site Number:8400136

location_facility: Mountain Neurological Research Center, Inc.-Site Number:8400128

location_facility: CHI Saint Joseph Medical Group Neurology-Site Number:8400110

location_facility: Optimed Research, LTD-Site Number:8400147

location_facility: Collaborative Neuroscience Research-Site Number:8400045

location_facility: Perelman Center for Advanced Medicine-Site Number:8400142

location_facility: University of Kansas Medical Center-Site Number:8400023

location_facility: University of South Florida-Site Number:8400006

location_facility: Sanford Brain & Spine Center-Site Number:8400126

location_facility: The Memorial Hospital-Site Number:8400033

location_facility: University of Alabama MS Center-Site Number:8400013

location_facility: Regina Berkovich, MD, PhD-Site Number:8400059

location_facility: Neurology Associates, PA-Site Number:8400004

location_facility: Providence Multiple Sclerosis Center-Site Number:8400020

location_facility: Multiple Sclerosis Center-Site Number:8400143

location_facility: Wayne State University-Site Number:8400046

location_facility: University Of Vermont College Of Medicine-Site Number:8400130

location_facility: Neurology Associates of Stony Brook-Site Number:8400042

location_facility: Meridian Clinical Research-Site Number:8400003

location_facility: Icahn School of Medicine at Mount Sinai (Department of Endoc-Site Number:8400038

location_facility: Tufts Medical Center-Site Number:8400072


acronym: CREST

title: A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC

lead_sponsor: Pfizer

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Poland
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Korea, Republic of
United States
France
China
Belgium
Japan
Germany

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: McMaster Institute of Urology/St Joseph's Healthcare Hamilton

location_facility: Urological Associates of Southern Arizona, P.C .

location_facility: University of California Irvine Medical Center

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Vancouver Prostate Centre at the Vancouver General Hospital

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: NYU Langone Medical Center (Tisch Hospital)

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Private Medical Institution "Euromedservice"

location_facility: Ospedale Area Aretina Nord - UOC Oncologia Medica

location_facility: Montefiore Medical Center - Oncology Investigational Services

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.

location_facility: DuPage Medical Group Ambulatory Surgery Center

location_facility: IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica

location_facility: Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean

location_facility: BHI of Omsk region "Clinical Oncological Dispensary"

location_facility: Associated Medical Professionals of New York, PLLC

location_facility: Klinikum der Goethe-Universitaet Frankfurt

location_facility: Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica

location_facility: John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy

location_facility: Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal

location_facility: Hamilton Regional Laboratory Medicine Program

location_facility: First Affiliated Hospital of Xi 'an Jiaotong University

location_facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

location_facility: A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation

location_facility: Regional Urology Oncology & Radiation Center

location_facility: UO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona

location_facility: UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"

location_facility: Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO

location_facility: Urological Associates of Southern Arizona P.C.

location_facility: Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic

location_facility: Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: IRCCS Ospedale San Raffaele, URI (Urological Research Institute)

location_facility: Kyungpook National University Chilgok Hospital

location_facility: John H. Stroger, Jr. Hospital of Cook County

location_facility: Montefiore Medical Center - Montefiore Medical Park

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kingston Health Sciences Centre -- Hotel Dieu Hospital

location_facility: Ospedale Generale Provinciale di Macerata - UOC Oncologia

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"

location_facility: State Budgetary Healthcare Institution "Leningrad Regional Clinical Oncology Dispensary"

location_facility: Polyclinique de Limoges Site Emailleurs-Colombier

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: ASST Sette Laghi Ospedale di Circolo Fondazione Macchi

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

location_facility: AO Azienda Ospedaliera Ordine Mauriziano Di Torino

location_facility: West China Hospital of Sichuan University

location_facility: UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Seoul National University Bundang Hospital

location_facility: Kingston Health Sciences Centre - Kingston General Hospital

location_facility: Fujian Medical University Affiliated First Hospital

location_facility: Barts Health NHS Trust, St Bartholomew's Hospital

location_facility: Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)

location_facility: P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research

location_facility: SBHI YaR Regional clinical oncology hospital

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: University Health Network - Toronto General Hospital

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Second Affiliated Hospital of Suzhou University

location_facility: Hospital Duran i Reynals- ICO L'Hospitalet

location_facility: IRCCS Azienda Ospedaliera Universitaria Policlinico San Martino Urologia

location_facility: Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa

location_facility: Kaluga Regional Clinical Oncology Center

location_facility: Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego

location_facility: Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"

location_facility: Sulpizio Cardiovascular Center at UC San Diego Health

location_facility: Federal State Budgetary Healthcare Institution Saint - Petersburg

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: State Budgetary Institution of Healthcare of the Republic of Mordovia

summary:
The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B).

In Part A (enrollment closed), each participant was assigned to one of three study treatment groups.

One group is given sasanlimab and BCG at the study clinic.
The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only.
The third group is given BCG only and will not receive sasanlimab.

In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor.

- Both groups will be given sasanlimab at the study clinic.


title: Randomized, Open Label Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated Metastatic Non- Squamous Non-Small Cell Lung Cancer Patients With CEACAM5 Positive Tumors

location_country:
Spain
Italy
United States
Belgium
Japan
Romania
Poland
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Brazil
Canada
Hungary
China
Germany
Bulgaria
Greece
Korea, Republic of
France
Chile
Netherlands

location_facility: Cancer Treatment Center of America(CTCA) - Southeastern-Site Number:8400015

location_facility: Florida Cancer Specialists North Division-Site Number:8400019

location_facility: Lankenau Hospital Cancer Center-Site Number:8400017

location_facility: St. Francis Cancer Center-Site Number:8400014

location_facility: Ca & Hem Center Of W Michigan-Site Number:8400016

location_facility: Comprehensive Blood and Cancer Center-Site Number:8400007

location_facility: Medical College of Wisconsin-Site Number:8400006

location_facility: Arizona Oncology Associates-Site Number:8400024

location_facility: Tennessee Oncology Nashville-Site Number:8400003

location_facility: Florida Cancer Specialists South Division-Site Number:8400020

summary:
Primary Objectives:

Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cutoff date for each given analysis (progression free survival [PFS] and overall survival [OS]).

Study success is defined either on PFS or OS

The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 ≥2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI).
The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 ≥2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor.

Secondary Objectives:

To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel
To compare the health related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel
To evaluate the safety of tusamitamab ravtansine compared to docetaxel
To assess the duration of response (DOR) of tusamitamab ravtansine with docetaxel


type: Other Grant/Funding Number

title: A Randomized Phase 3 Multicenter Open-Label Study to Compare the Efficacy of TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

summary:
The purpose of this study is to compare the effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group.

Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Hong Kong
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Sweden
Singapore
Canada
Switzerland
China
Germany
Denmark
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Baskent University Medical Faculty Adana Practice and Research Center

location_facility: Centro Hospitalar do Porto Hospital de Santo Antonio

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: The Christie NHS Foundation Trust - PPDS

location_facility: Hospital Regional Universitario de Malaga Hospital General

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

location_facility: National Taiwan University Hospital - YunLin Branch

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Private Enterprise Private Manufacturing Company Acinus

location_facility: Beijing Chest Hospital, Capital Medical Univerity

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

location_facility: University of Maryland Greenebaum Cancer Center

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

location_facility: National Hospital Organization Yamaguchi-Ube Medical Center

location_facility: ICO lHospitalet Hospital Duran i Reynals

location_facility: Harbin Medical University Tumor Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Eastern CT Hematology and Oncology Associates

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

location_facility: Municipal Non-profit Enterprise SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Centro Hospitalar de Lisboa Norte E.P.E Hospital Pulido Valente

location_facility: Hospital General Universitario de Alicante

location_facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: The First Affiliated Hospital, College of Medicine, Zhejiang University

location_facility: Scientific Research Institute of Oncology n.a. N.N. Petrov

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: University College London Hospitals (UCLH)

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital

location_facility: Malteser Krankenhaus St. Franziskus-Hospital

location_facility: T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital


title: A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

acronym: CheckMate 9DW

summary: The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

lead_sponsor: Bristol-Myers Squibb

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

location_facility:
Local Institution - 0284
Local Institution - 0068
Local Institution - 0148
Local Institution - 0155
Local Institution - 0036
Local Institution - 0078
Local Institution - 0138
Local Institution - 0157
Local Institution - 0262
Local Institution - 0127
Local Institution - 0069
Local Institution - 0181
Local Institution - 0128
Local Institution - 0261
Local Institution - 0029
Local Institution - 0307
Local Institution - 0033
Local Institution - 0179
Local Institution - 0263
Local Institution - 0093
Local Institution - 0003
Local Institution - 0042
Local Institution - 0038
Local Institution - 0103
Local Institution - 0075
Local Institution - 0026
Local Institution - 0016
Local Institution - 0282
Local Institution - 0073
Local Institution - 0108
Local Institution - 0100
Local Institution - 0001
Local Institution - 0203
Local Institution - 0052
Local Institution - 0081
Local Institution - 0019
Local Institution - 0149
Local Institution - 0013
Local Institution - 0097
Local Institution - 0050
Local Institution - 0274
Local Institution - 0164
Local Institution - 0066
Local Institution - 0043
Local Institution - 0178
Local Institution - 0077
Local Institution - 0297
Local Institution - 0278
Local Institution - 0070
Local Institution - 0006
Local Institution - 0189
Local Institution - 0147
Local Institution - 0192
Local Institution - 0288
Local Institution - 0022
Local Institution - 0292
Local Institution - 0107
Local Institution - 0175
Local Institution - 0231
Local Institution - 0139
Local Institution - 0162
Local Institution - 0040
Local Institution - 0165
Local Institution - 0062
Local Institution - 0290
Local Institution - 0185
Local Institution - 0131
Local Institution - 0112
Local Institution - 0137
Local Institution - 0170
Local Institution - 0122
Local Institution - 0071
Local Institution - 0102
Local Institution - 0144
Local Institution - 0283
Local Institution - 0176
Local Institution - 0141
Local Institution - 0188
Local Institution - 0034
Local Institution - 0298
Local Institution - 0199
Local Institution - 0023
Local Institution - 0279
Local Institution - 0173
Local Institution - 0060
Local Institution - 0084
Local Institution - 0163
Local Institution - 0168
Local Institution - 0295
Local Institution - 0109
Local Institution - 0064
Local Institution - 0039
Local Institution - 0035
Local Institution
Local Institution - 0046
Local Institution - 0121
Local Institution - 0002
Local Institution - 0058
Local Institution - 0055
Local Institution - 0045
Local Institution - 0271
Local Institution - 0004
Local Institution - 0204
Local Institution - 0089
Local Institution - 0116
Local Institution - 0104
Local Institution - 0270
Local Institution - 0094
Local Institution - 0177
Local Institution - 0135
Local Institution - 0047
Local Institution - 0166
Local Institution - 0057
Local Institution - 0061
Local Institution - 0186
Local Institution - 0289
Local Institution - 0051
Local Institution - 0015
Local Institution - 0194
Local Institution - 0160
Local Institution - 0025
Local Institution - 0110
Local Institution - 0171
Local Institution - 0082
Local Institution - 0114
Local Institution - 0087
Local Institution - 0296
Local Institution - 0151
Local Institution - 0123
Local Institution - 0101
Local Institution - 0085
Local Institution - 0156
Local Institution - 0028
Local Institution - 0054
Local Institution - 0065
Local Institution - 0041
Local Institution - 0193
Local Institution - 0129
Local Institution - 0099
Local Institution - 0133
Local Institution - 0007
Local Institution - 0079
Local Institution - 0174
Local Institution - 0063
Local Institution - 0095
Local Institution - 0072
Local Institution - 0153
Local Institution - 0032
Local Institution - 0200
Local Institution - 0152
Local Institution - 0130
Local Institution - 0017
Local Institution - 0049
Local Institution - 0037
Local Institution - 0111
Local Institution - 0056
Local Institution - 0012
Local Institution - 0027
Local Institution - 0096
Local Institution - 0059
Local Institution - 0201
Local Institution - 0286
Local Institution - 0005
Local Institution - 0132
Local Institution - 0125
Local Institution - 0048
Local Institution - 0280
Local Institution - 0090
Local Institution - 0105
Local Institution - 0154
Local Institution - 0219
Local Institution - 0259
Local Institution - 0088
Local Institution - 0190
Local Institution - 0018
Local Institution - 0098
Local Institution - 0143
Local Institution - 0024
Local Institution - 0092
Local Institution - 0140
Local Institution - 0053
Local Institution - 0167
Local Institution - 0272
Local Institution - 0202
Local Institution - 0134
Local Institution - 0120
Local Institution - 0020
Local Institution - 0136
Local Institution - 0258
Local Institution - 0031
Local Institution - 0142
Local Institution - 0150
Local Institution - 0146
Local Institution - 0074
Local Institution - 0216
Local Institution - 0091
Local Institution - 0281
Local Institution - 0118
Local Institution - 0304
Local Institution - 0172
Local Institution - 0009
Local Institution - 0044
Local Institution - 0008
Local Institution - 0145
Local Institution - 0067


title: Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)

summary:
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery.

Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer.

Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

lead_sponsor: Seagen Inc.

location_country:
Denmark
Taiwan
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Switzerland
Sweden
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany
Singapore

location_facility: Cancer Treatment Centers of America / Eastern Regional Medical Center

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

location_facility: University of Ottawa / Ottawa General Hospital

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: University of California at San Francisco

location_facility: Klinikum Rechts der Isar der Technischen Universitat Munchen

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval

location_facility: Kapi'olani Medical Center for Women and Children

location_facility: Helen F. Graham Cancer Center / Christiana Care Health Systems

location_facility: Hakuaikai Sagara Hospital/Breast Surgery

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: University of California Irvine - Newport

location_facility: Grand Hôpital de Charleroi - Saint-Joseph

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Tianjin Medical University - Cancer Institute & Hospital

location_facility: Ft Wayne Medical Oncology and Hematology, Inc TRIO

location_facility: Kaiser Permanente Medical Center Northern California

location_facility: Chao Family Comprehensive Cancer Center University of California Irvine

location_facility: The Center for Cancer and Blood Disorders: Fortworth

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Cancer Treatment Centers of America / Western Regional Medical Center

location_facility: University of Pennsylvania / Perelman Center for Advanced Medicine

location_facility: University of Colorado Hospital / University of Colorado

location_facility: Saint Barnabas Medical Center Cancer Center

location_facility: Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care

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

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Institute Curie - Centre de Lutte Contre Le Cancer CLCC de Paris

location_facility: North Mississippi Medical Center Hematology Oncology - Tupelo

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Florida Cancer Specialists - South Region

location_facility: First Affiliated Hospital of Zhejiang University

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Hopital Saint-Louis / Service d'Hematologie

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: UCLA Medical Center / David Geffen School of Medicine

location_facility: The Affiliated Hospital of Guangdong Medical University

location_facility: National University Cancer Institute, Singapore

location_facility: Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo FPO - IRCCS

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Seconda Università degli Studi di Napoli, AOU

location_facility: University of Colorado Health Memorial Hospital

location_facility: Ironwood Cancer & Research Centers - Chandler

location_facility: The Royal Marsden NHS Foundation Trust (RM)

location_facility: Centre de Lutte contre le Cancer - François Baclesse

location_facility: Gulou Hospital Affiliated to Nanjing University Medical College

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: CHI Saint Joseph Medical Group Cancer Care Center

location_facility: California Cancer Associates for Research and Excellence Inc (cCARE)

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Saint Francis Hospital / Bon Secours - Virginia

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: Illinois Cancer Specialists - Arlington Heights

location_facility: National Hospital Organization Kyushu Cancer Center

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

location_facility: Kliniken Essen-Mitte - Evang. Huyssens-Stiftung

location_facility: InVO- Institut fUr Versorgungsforschung in der onkologie GbR

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Seoul National University Bundang Hospital

location_facility: Cancer Centre of Southeastern Ontario At Kingston General Hospital

location_facility: Goteborgs Universitet - Sahlgrenska Akademin - Institutionen For Kliniska Vetenskaper (Institute Of Clinical Sciences)

location_facility: University Hospital Basel - Brustzentrum

location_facility: University of South Alabama - Mitchell Cancer Institute

location_facility: Hospital Center Regional University Morvan De Brest

location_facility: LKH Salzburg, Universitatsklinikum der PMU

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Centre de Recherche du Centre Hospitalier de l'Universite de Montreal

location_facility: Texas Oncology - Methodist Dallas Cancer Center

location_facility: Skanes University Hospital - Universitetssjukhus

location_facility: SCL Health Good Samaritan Medical Center Cancer Centers of Colorado

location_facility: Torrance Memorial Physician Network - TRIO

location_facility: Florida Cancer Specialists - North Region

location_facility: Brig Center for Cancer Care and Survivorship

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Alberta / Cross Cancer Institute

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Xi'An International Medical Center Hospital

location_facility: Lombardi Cancer Center / Georgetown University Medical Center

location_facility: Institute of Oncology of Southern Switzerland


title: A Phase 3, Multicenter, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Fedratinib Compared to Best Available Therapy (BAT) in Subjects With DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) and Previously Treated With Ruxolitinib

summary: A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in subjects with DIPSS (Dynamic International Prognostic Scoring System)-intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) and previously treated with ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least 35% spleen volume reduction in the fedratinib and the BAT arms.

location_country:
Poland
Spain
Ireland
Austria
Australia
Italy
Netherlands
Russian Federation
United Kingdom
Hungary
Korea, Republic of
France
China
Belgium
Germany
Czechia

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele - Ospedale Gaspare Rodolico

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Soon Chun Hyang University Hospital Seoul

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Chinese Academy of Medical Sciences & Peking Union Medical College

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Centre Hospitalier Lyon Sud - Hospices Civils de Lyon Groupement Hospitalier Sud

location_facility: University of Heidelberg - Universitatsklinikum Mannheim

location_facility: Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency

location_facility: Fujian Medical University Union Hospital

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: Policlinico Umberto I - Universita La Sapienza

location_facility: Instituto Catalan de Oncologia de Girona

location_facility: Hospital General Universitario de Alicante

location_facility: Salzburger Landkliniken St. Johanns-Spital

location_facility: IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin

location_facility: Universitario de Salamanca - Hospital Clinico

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Szegedi Tudomanyegyetem - Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Seoul St Marys Hospital College of Medicine The Catholic University of Korea

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Novosibirsk State Medical University (NSMU)

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: Azienda Ospedaliera S. Andrea - Università La Sapienza

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Instytut Hematologii i Transfuzjologii w Warszawie

location_facility: FSBI Hematology Research Center Ministry of Healthcare of the Russian Federation

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Centre Hospitalier Universitaire de Nimes - Hopital Universitaire Caremeau

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine