acronym: ELIXA

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome

lead_sponsor: Sanofi

ReferenceType: background

ReferenceCitation: Bentley-Lewis R, Aguilar D, Riddle MC, Claggett B, Diaz R, Dickstein K, Gerstein HC, Johnston P, Køber LV, Lawson F, Lewis EF, Maggioni AP, McMurray JJ, Ping L, Probstfield JL, Solomon SD, Tardif JC, Wu Y, Pfeffer MA; ELIXA Investigators. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015 May;169(5):631-638.e7. doi: 10.1016/j.ahj.2015.02.002. Epub 2015 Feb 12.

ReferenceCitation: Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJ, Probstfield JL, Riddle MC, Solomon SD, Tardif JC; ELIXA Investigators. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57. doi: 10.1056/NEJMoa1509225.

ReferenceCitation: Gerstein HC, Hess S, Claggett B, Dickstein K, Kober L, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Pfeffer MA. Protein Biomarkers and Cardiovascular Outcomes in People With Type 2 Diabetes and Acute Coronary Syndrome: The ELIXA Biomarker Study. Diabetes Care. 2022 Sep 1;45(9):2152-2155. doi: 10.2337/dc22-0453.

ReferenceCitation: Wijkman MO, Claggett B, Diaz R, Gerstein HC, Køber L, Lewis E, Maggioni AP, Wolsk E, Aguilar D, Bentley-Lewis R, McMurray JJ, Probstfield J, Riddle M, Tardif JC, Solomon SD, Pfeffer MA. Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial. Cardiovasc Diabetol. 2020 Oct 12;19(1):175. doi: 10.1186/s12933-020-01150-0.

ReferenceCitation: Shin SH, Claggett B, Pfeffer MA, Skali H, Liu J, Aguilar D, Diaz R, Dickstein K, Gerstein HC, Køber LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Solomon SD; ELIXA Investigators. Hyperglycaemia, ejection fraction and the risk of heart failure or cardiovascular death in patients with type 2 diabetes and a recent acute coronary syndrome. Eur J Heart Fail. 2020 Jul;22(7):1133-1143. doi: 10.1002/ejhf.1790. Epub 2020 Mar 25.

ReferenceCitation: Seferovic JP, Bentley-Lewis R, Claggett B, Diaz R, Gerstein HC, Køber LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Pfeffer MA. Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration. J Diabetes Res. 2018 Dec 16;2018:1631263. doi: 10.1155/2018/1631263. eCollection 2018.

ReferenceCitation: Muskiet MHA, Tonneijck L, Huang Y, Liu M, Saremi A, Heerspink HJL, van Raalte DH. Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):859-869. doi: 10.1016/S2213-8587(18)30268-7. Epub 2018 Oct 3.

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.

ReferenceCitation: Wolsk E, Claggett B, Pfeffer MA, Diaz R, Dickstein K, Gerstein HC, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Køber L. Role of B-Type Natriuretic Peptide and N-Terminal Prohormone BNP as Predictors of Cardiovascular Morbidity and Mortality in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. J Am Heart Assoc. 2017 May 29;6(6). pii: e004743. doi: 10.1161/JAHA.116.004743.

ReferenceCitation: Wohlfart P, Linz W, Hübschle T, Linz D, Huber J, Hess S, Crowther D, Werner U, Ruetten H. Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies. J Transl Med. 2013 Mar 28;11:84. doi: 10.1186/1479-5876-11-84.

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Investigational Site Number 688002
Investigational Site Number 840299
Investigational Site Number 208003
Investigational Site Number 643018
Investigational Site Number 643059
Investigational Site Number 840196
Investigational Site Number 380014
Investigational Site Number 643045
Investigational Site Number 840464
Investigational Site Number 376009
Investigational Site Number 356032
Investigational Site Number 642011
Investigational Site Number 840506
Investigational Site Number 840415
Investigational Site Number 826052
Investigational Site Number 036009
Investigational Site Number 218002
Investigational Site Number 616011
Investigational Site Number 208008
Investigational Site Number 484028
Investigational Site Number 840439
Investigational Site Number 826019
Investigational Site Number 826037
Investigational Site Number 356014
Investigational Site Number 840640
Investigational Site Number 840560
Investigational Site Number 840180
Investigational Site Number 356017
Investigational Site Number 100016
Investigational Site Number 380020
Investigational Site Number 076021
Investigational Site Number 076002
Investigational Site Number 356025
Investigational Site Number 710006
Investigational Site Number 276017
Investigational Site Number 276014
Investigational Site Number 710019
Investigational Site Number 356019
Investigational Site Number 840621
Investigational Site Number 320014
Investigational Site Number 032037
Investigational Site Number 152023
Investigational Site Number 356004
Investigational Site Number 484006
Investigational Site Number 642010
Investigational Site Number 604009
Investigational Site Number 170022
Investigational Site Number 036015
Investigational Site Number 840168
Investigational Site Number 840345
Investigational Site Number 124005
Investigational Site Number 643055
Investigational Site Number 840698
Investigational Site Number 376004
Investigational Site Number 208002
Investigational Site Number 840001
Investigational Site Number 826040
Investigational Site Number 643003
Investigational Site Number 643061
Investigational Site Number 752012
Investigational Site Number 392018
Investigational Site Number 484023
Investigational Site Number 840346
Investigational Site Number 840456
Investigational Site Number 840152
Investigational Site Number 152001
Investigational Site Number 380006
Investigational Site Number 616001
Investigational Site Number 643033
Investigational Site Number 356016
Investigational Site Number 376008
Investigational Site Number 804013
Investigational Site Number 818002
Investigational Site Number 356028
Investigational Site Number 840007
Investigational Site Number 642002
Investigational Site Number 250011
Investigational Site Number 604013
Investigational Site Number 643051
Investigational Site Number 840266
Investigational Site Number 376006
Investigational Site Number 032011
Investigational Site Number 840509
Investigational Site Number 710014
Investigational Site Number 032039
Investigational Site Number 276024
Investigational Site Number 356020
Investigational Site Number 840404
Investigational Site Number 124003
Investigational Site Number 752011
Investigational Site Number 152042
Investigational Site Number 840608
Investigational Site Number 158003
Investigational Site Number 840217
Investigational Site Number 356021
Investigational Site Number 276020
Investigational Site Number 208007
Investigational Site Number 840623
Investigational Site Number 032024
Investigational Site Number 156013
Investigational Site Number 156028
Investigational Site Number 392013
Investigational Site Number 170013
Investigational Site Number 152002
Investigational Site Number 100004
Investigational Site Number 826016
Investigational Site Number 233003
Investigational Site Number 608001
Investigational Site Number 032018
Investigational Site Number 804008
Investigational Site Number 643024
Investigational Site Number 233004
Investigational Site Number 643025
Investigational Site Number 840314
Investigational Site Number 032055
Investigational Site Number 036001
Investigational Site Number 818001
Investigational Site Number 688001
Investigational Site Number 840135
Investigational Site Number 840119
Investigational Site Number 032036
Investigational Site Number 826018
Investigational Site Number 076013
Investigational Site Number 170009
Investigational Site Number 032023
Investigational Site Number 124007
Investigational Site Number 380024
Investigational Site Number 170002
Investigational Site Number 392009
Investigational Site Number 376005
Investigational Site Number 032063
Investigational Site Number 356023
Investigational Site Number 840477
Investigational Site Number 710002
Investigational Site Number 784002
Investigational Site Number 792013
Investigational Site Number 032058
Investigational Site Number 076025
Investigational Site Number 124026
Investigational Site Number 840240
Investigational Site Number 826046
Investigational Site Number 642033
Investigational Site Number 840308
Investigational Site Number 392007
Investigational Site Number 840532

summary:
Primary Objective:

- To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome (ACS) event.

Secondary Objectives:

To demonstrate that when compared to placebo, lixisenatide can reduce:

composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure.
composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure.
urinary albumin excretion (based on the urinary albumin/creatinine ratio).

To assess the safety and tolerability of lixisenatide.


type: Other Identifier

title: Use of Duloxetine or Pregabalin in Monotherapy Versus Combination Therapy of Both Drugs in Patients With Painful Diabetic Neuropathy "The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study"

acronym: COMBO-DN

summary: This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Eli Lilly and Company

location_country:
Croatia
Poland
Spain
Greece
Italy
Australia
Netherlands
Canada
United Kingdom
Switzerland
Sweden
Korea, Republic of
France
Turkey
Mexico
Germany

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ipd_sharing: Yes

status: Active, not recruiting

title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1

study_completion_date_type: Anticipated

lead_sponsor: Daiichi Sankyo, Inc.

type: EudraCT Number

type: Registry Identifier

source: euctr

study_start_date_type: Actual

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

enrollment_type: Anticipated

location_country:
Brazil
Spain
Greece
Italy
Australia
United Kingdom
Korea, Republic of
United States
France
Israel
Turkey
Belgium
Japan
Germany
Czechia

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: Konya Necmettin Erbakan University Meram Faculty of Medicine

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Ankara Yildirim Beyazit Uni. Med. Fac.Ankara City Hospital

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center

location_facility: Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

location_facility: Hospital de Especialidades de Jerez de la Frontera

location_facility: Adana Numune Training and Research Hospital

location_facility: Klinikum der Universitaet Muenchen - Campus Grosshardern

location_facility: Sociedade Beneficiente de Senhoras Hospital Sírio Libanês

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: CliniOnco - Tratamento Integrado do Câncer

location_facility: Azienda Ospedaliero Universitaria Pisana

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

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: General Oncology Hospital of Kifissia " Agioi Anargyroi"

location_facility: Nottingham University Hospitals City Campus

location_facility: Hiroshima City Hiroshima Citizens Hospital

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

location_facility: North Shore Hematology Oncology Associates, PC

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital

location_facility: Kyungpook National University Chilgok Hospital

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

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Peninsula and South Eastern Haematology & Oncology Group

location_facility: AMO - Assistência Multidisciplinar em Oncologia

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Kartal Lutfi Kirdar Research and Training Hospital

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Seoul National University Bundang Hospital

location_facility: Istanbul Medeniyet Uni Goztepe Training & Research Hospital

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Azienda Ospealiera della Provincia di Lecco

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

location_facility: The Methodist Hospital Research Institute

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University General Hospital of Heraklion

location_facility: Kapiolani Medical Center for Women and Children/Univ of HI

location_facility: Royal Devon and Exeter Hospital (Wonford)

summary:
This study will compare DS 8201a to standard treatment.

Participants must have HER2 breast cancer that has been treated before.

Their cancer:

cannot be removed by an operation
has spread to other parts of the body

status_simplified: Ongoing


title: A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

status: Recruiting

ReferenceType: derived

ReferenceCitation: Pérez-García J, Soberino J, Racca F, Gion M, Stradella A, Cortés J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25. Review.

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
Romania
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Singapore
Brazil
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Ireland
Thailand
Korea, Republic of
France

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: St. Luke's Internat. Hospital, Breast Surgical Oncology

location_facility: The 307th Hospital of Chinese People's Liberation Army

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Belgorod Regional Oncology Dispensary; Chemotherapy

location_facility: Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: CHU de Grenoble - Hôpital André Michallon

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: Wojskowy Inst.Medyczny Mon; Klinika Onkologii

location_facility: Chernivtsi Regional Clinical Oncology Dispensary

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala

location_facility: Sun yat-sen University Cancer Center; Internal Medicine of Oncology

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

location_facility: Intermountain Precision Genomics Cancer Research Clinic-Dixie

location_facility: Beaumont Hospital; Cancer Clinical Trials Unit

location_facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

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

location_facility: Transkarpathian Regional Oncology Clinic; Chemotherapy

location_facility: Calderdale and Huddersfield NHS Foundation Trust

location_facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Hospital Mutua de Terrassa; Servicio de Oncologia

location_facility: The 900th Hospital of PLA joint service support force

location_facility: Saitama Medical University International Medical Center

location_facility: The Affiliated Hospital of Medical College Qingdao University

location_facility: Universidade de Caxias do Sul - Rio Grande do Sul

location_facility: NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital

location_facility: Bağcılar Medipol Mega Üniversite Hastanesi; Oncology

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Hirslanden Medical Center - Tumorzentrum

location_facility: St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz

location_facility: Adana Acıbadem Hospital Oncology Department

location_facility: Klinikum Kreuzschwestern Wels; Iv. Interne Abt.

location_facility: Hospital de Donostia.; Servicio de Oncología Radioterápica

location_facility: Hospital Infanta Sofia; Servico de Oncologia

location_facility: CH Annecy Genevois site Annecy; Oncologie

location_facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

location_facility: Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Austin Hospital Olivia Newton John Cancer Centre

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Sun Yat-Sen University Cancer Center - Huangpu Campus

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Centro Di Riferimento Oncologico; SOC Oncologia Medica C

location_facility: Sumy Reg. Clin. Oncological Dispensary; Thoracall Department

location_facility: MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department

location_facility: The First Affiliated Hospital of Xian Jiao Tong University

location_facility: CRLCC-Francois Baclesse; Oncologie Médicale

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira

location_facility: CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie

location_facility: Hopital Prive Drome Ardeche; Hopital De Jour

location_facility: Chiang Rai Prachanukroh Hospital; Department Of Medicine

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi

location_facility: The Second Affiliated Hospital of Zhejiang University College

location_facility: Municipal Institution Odesa Regional Oncology Dispensary

location_facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: "Filantropia" Clinical Hospital; Gynecological Oncology

location_facility: National Medical Research Center for Oncology

location_facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

location_facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

location_facility: Vinnytsya Regional Clinical Oncology Dispensary

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

location_facility: Ospedale Civile Di Sondrio; Divisione Medicina Generale

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

location_facility: GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe

location_facility: Chi De Cornouaille; Oncologie Hospitalisation

location_facility: Izmir Ekonomi Universitesi Medical Park Hastanesi

location_facility: Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy

location_facility: Gemeinschaftspraxis für Onkologie und Hämatologie

location_facility: Regional Oncology Dispensary; Dept of Chemotherapy

location_facility: BIH at Omsk Region "Clinical Oncology Dispensary", Outpatient clinic

location_facility: General Hospital Hietzing, KLI; Dept. Obstet&Gynecol

location_facility: Albertinen-Krankenhaus Klinik f.Gynäkologie und Geburtshilfe

location_facility: Sjællands Universitetshospital, Næstved; Onkologisk Afdeling

location_facility: Vehbi Koc Vakfi (VKV) - Amerikan Hastanesi

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Centro de Estudios y Prevencion del Cancer AC

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

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

location_facility: Severance Hospital; Yonsei University Health System

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Hadassah Med Org Kiryat; Oncology Institute

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Private Healthcare Institution Clinical Hospital RZhD Medicine

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Hospital Universitario Virgen de la Macarena;

location_facility: Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller

location_facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Hospital de Torrevieja; Servicio de Oncologia

location_facility: Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico; U.O.C. di Oncologia Medica

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: Queen Elizabeth Hospital Department of Clinical Oncology

location_facility: E-Da Cancer Hospital; Hematology- Oncology Department

location_facility: Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

location_facility: Rochester General Hospital; Lipson Cancer and Blood Center

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: Fairview Southdale Medical Oncology Clinic

location_facility: National University Hospital; Medical Oncology

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Nizhny Novgorod Regional Clinical Oncology Center

location_facility: Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

location_facility: Instituto Brasileiro de Controle Do Câncer - São Camilo Oncologia

location_facility: Hospital Universitari Sant Joan de Reus; Planta baja, color lila

location_facility: Monument Health Rapid City Hospital, Inc.

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Centro de Oncologia e; Investigacion Buenos Aires - COIBA

location_facility: Klinikum der Universität München; Frauenklinik - Onkologie II

location_facility: Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: T.C. Saglik Bakanligi Istanbul Il Saglik Mudurlugu Prof. Dr. Cemil Tascioglu Sehir Hastanesi

location_facility: Kantonsspital Olten; Medizinische Klinik

location_facility: Taipei Medical University -Shuang Ho Hospital

location_facility: Southeastern Medical Oncology Center - Goldsboro

location_facility: Ospedale Santa Maria Annunziata; Oncologia

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology

location_facility: Fujian Medical University Union Hospital

location_facility: Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi

location_facility: Ospedale Degli Infermi - Faenza; Oncologia Medica

location_facility: Advocate Illinois Masonic Outpatient Center for Advanced Care

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Gynäkologisch Onkologische Praxis Hannover

location_facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

location_facility: University of Maryland Greenebaum Comprehensive Cancer Center

location_facility: Centre Armoricain de Radiotherapie, de Imagerie Medicale et de Oncologie (CARIO)

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia

location_facility: Ege Universitesi Hastanesi (Saglik Uygulama ve Arastirma Merkezi)

location_facility: Nemocnice Horovice, NH Hospital a.s.; Oncology Department

location_facility: Regional Oncology Center; Department of Mammology

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Municipal Institution Kirovograd Regional Oncology Dispensary

location_facility: Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica

location_facility: GUZ Kaluga Regional Oncological Dispensary

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Hospital General De Catalunya; Servicio de Oncologia

location_facility: Centre Hospitalier de Mont de Marsan - Hopital Layne

location_facility: Des Moines Oncology Research Association

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Hospital Universitario Rey Juan Carlos de Móstoles; Servicio de Neurología

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Ospedale Civile; Day Hospital Oncologico

location_facility: Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Federal State Institution Medical Radiology Research Center

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi

location_facility: Hospital Ruber Internacional;Servicio de Oncologia

location_facility: Hospital Universitario de Fuenlabrada; Servicio de Oncologia

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

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Beijing Hospital; Internal Medicine-Oncology

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: John Muir Health Clinical Research Center

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin

location_facility: University of Maryland; St. Joseph Medical Center

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Centro Oncologico de Galicia COG; Medical Oncology

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: NHS Greater Glasgow and Clyde; Beatson West of Scotland Cancer Centre

location_facility: LCC Center of Palliative Medicine - Devita

location_facility: Box Hill Hospital; Eastern Clinical Research Unit

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi

location_facility: Icon Cancer Foundation; Icon Cancer Care Southport

location_facility: CCCH City Oncological Center SHEI Uzhgorod NU

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Siriraj Hospital; Clinical Research Center, Pharmacy Department

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: U.O Medicina Oncologica Ospedale di Carpi

location_facility: Hacettepe Universitesi Onkoloji Hastanesi

location_facility: Mackay Memorial Hospital - Taipei Branch

location_facility: China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie

location_facility: Medical University Innsbruck; Frauenklinik Innsbruck, Dept Gyn

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: AKH - Medizinische Universität Wien; Department of Oncology

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: SHI Volgograd Regional Clinical Oncological Dispensary#1

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Icon Cancer Foundation; Icon Cancer Care Chermside

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

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Centro Integral Oncológico Clara Campal Ensayos Clínicos START

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University

location_facility: Princess Alexandra Hospital; Cancer Trials Unit

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

location_facility: University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

location_facility: Hospital Infanta Cristina; Servicio de Oncologia

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Municipal Institution Odesa Regional Clinical Hospital


title: A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma Treated With Gemcitabine Followed by Brentuximab Vedotin Maintenance

summary: This study is an open label, multicenter phase 2 study. The primary objective of the study is to determine the efficacy of brentuximab vedotin in patients treated by gemcitabine for relapsed or refractory peripheral T-cell lymphoma in term of overall response rate assessed after 4 cycles of treatment according to the international response criteria for malignant lymphoma (Lugano Classification 2014 - CT-Based Response).

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: France Belgium

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Centre François Magendie - Hôpital du Haut Lévêque

intervention_type: Procedure