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ReferenceCitation: Ferreira JP, Inzucchi SE, Mattheus M, Meinicke T, Steubl D, Wanner C, Zinman B. Empagliflozin and uric acid metabolism in diabetes: A post hoc analysis of the EMPA-REG OUTCOME trial. Diabetes Obes Metab. 2021 Sep 24. doi: 10.1111/dom.14559. [Epub ahead of print]

name: Université de Lorraine, Centre d'Investigations Cliniques Plurithématique 1433 and Inserm U1116, Centre Hospitalier Universitaire de Nancy, FCRIN INI‐CRCT (Cardiovascular and Renal Clinical Trialists)  Nancy France

name: Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto  Porto Portugal

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name: Department of Nephrology, Faculty of Medicine Technical University Munich  Munich Germany

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title: Empagliflozin and uric acid metabolism in diabetes: A post hoc analysis of the EMPA‐REG OUTCOME trial

ReferenceCitation: Sharma A, Ofstad AP, Ahmad T, Zinman B, Zwiener I, Fitchett D, Wanner C, George JT, Hantel S, Desai N, Mentz RJ. Patient Phenotypes and SGLT-2 Inhibition in Type 2 Diabetes: Insights From the EMPA-REG OUTCOME Trial. JACC Heart Fail. 2021 Aug;9(8):568-577. doi: 10.1016/j.jchf.2021.03.003.

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family: Mentz

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journal_name: JACC: Heart Failure

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title: Patient Phenotypes and SGLT-2 Inhibition in Type 2 Diabetes

ReferenceCitation: Cherney DZI, Dagogo-Jack S, McGuire DK, Cosentino F, Pratley R, Shih WJ, Frederich R, Maldonado M, Liu J, Wang S, Cannon CP; VERTIS CV Investigators. Kidney outcomes using a sustained ≥40% decline in eGFR: A meta-analysis of SGLT2 inhibitor trials. Clin Cardiol. 2021 Aug;44(8):1139-1143. doi: 10.1002/clc.23665. Epub 2021 Jun 15.

name: Division of Nephrology University of Toronto  Toronto Ontario Canada

name: Division of Endocrinology, Diabetes and Metabolism University of Tennessee Health Science Center  Memphis Tennessee USA

name: Division of Cardiology University of Texas Southwestern Medical Center, and Parkland Health and Hospital System  Dallas Texas USA

name: Unit of Cardiology Karolinska Institute and Karolinska University Hospital  Stockholm Sweden

name: AdventHealth Translational Research Institute  Orlando Florida USA

name: Department of Biostatistics and Epidemiology Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey  New Brunswick New Jersey USA

name: Clinical Development and Operations Research and Development, Pfizer Inc.  Collegeville Pennsylvania USA

name: Diabetes and Endocrinology MSD Limited  London UK

name: Global Product Development Statistics Merck & Co., Inc.  Kenilworth New Jersey USA

name: Cardiovascular Division, Brigham and Women's Hospital Harvard Medical School  Boston Massachusetts USA

title: Kidney outcomes using a sustained ≥40% decline in eGFR : A meta‐analysis of SGLT2 inhibitor trials

ReferenceCitation: Ferreira JP, Kraus BJ, Zwiener I, Lauer S, Zinman B, Fitchett DH, Koitka-Weber A, George JT, Ofstad AP, Wanner C, Zannad F. Cardio/Kidney Composite End Points: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. J Am Heart Assoc. 2021 Apr 6;10(7):e020053. doi: 10.1161/JAHA.120.020053. Epub 2021 Mar 23.

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name: Department of Internal Medicine I University Hospital Würzburg Würzburg Germany

name: Comprehensive Heart Failure Centre University of Würzburg Würzburg Germany

name: Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim Germany

name: Lunenfeld‐Tanenbaum Research Institute Mount Sinai HospitalUniversity of Toronto Ontario Canada

name: Division of Cardiology St. Michael’s HospitalUniversity of Toronto Ontario Canada

name: Department of Diabetes Central Clinical School Monash University Melbourne Australia

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journal_name: Journal of the American Heart Association

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

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

title: Cardio/Kidney Composite End Points: A Post Hoc Analysis of the EMPA‐REG OUTCOME Trial

ReferenceCitation: Ferreira JP, Verma S, Fitchett D, Ofstad AP, Lauer S, Zwiener I, George J, Wanner C, Zinman B, Inzucchi SE. Metabolic syndrome in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a post hoc analyses of the EMPA-REG OUTCOME trial. Cardiovasc Diabetol. 2020 Nov 26;19(1):200. doi: 10.1186/s12933-020-01174-6.

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ReferenceCitation: McGuire DK, Zinman B, Inzucchi SE, Wanner C, Fitchett D, Anker SD, Pocock S, Kaspers S, George JT, von Eynatten M, Johansen OE, Jamal W, Mattheus M, Elsasser U, Hantel S, Lund SS. Effects of empagliflozin on first and recurrent clinical events in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a secondary analysis of the EMPA-REG OUTCOME trial. Lancet Diabetes Endocrinol. 2020 Dec;8(12):949-959. doi: 10.1016/S2213-8587(20)30344-2.

ReferenceCitation: Ceriello A, Ofstad AP, Zwiener I, Kaspers S, George J, Nicolucci A. Empagliflozin reduced long-term HbA1c variability and cardiovascular death: insights from the EMPA-REG OUTCOME trial. Cardiovasc Diabetol. 2020 Oct 13;19(1):176. doi: 10.1186/s12933-020-01147-9.

ReferenceCitation: Neeland IJ, Eliasson B, Kasai T, Marx N, Zinman B, Inzucchi SE, Wanner C, Zwiener I, Wojeck BS, Yaggi HK, Johansen OE; EMPA-REG OUTCOME Investigators. The Impact of Empagliflozin on Obstructive Sleep Apnea and Cardiovascular and Renal Outcomes: An Exploratory Analysis of the EMPA-REG OUTCOME Trial. Diabetes Care. 2020 Dec;43(12):3007-3015. doi: 10.2337/dc20-1096. Epub 2020 Oct 1.

ReferenceCitation: Levin A, Perkovic V, Wheeler DC, Hantel S, George JT, von Eynatten M, Koitka-Weber A, Wanner C; EMPA-REG OUTCOME Investigators. Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial. Clin J Am Soc Nephrol. 2020 Oct 7;15(10):1433-1444. doi: 10.2215/CJN.14901219. Epub 2020 Sep 29.

name: on behalf of the EMPA-REG OUTCOME Investigators

journal_name: Clinical Journal of the American Society of Nephrology

title: Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories

ReferenceCitation: Waijer SW, Xie D, Inzucchi SE, Zinman B, Koitka-Weber A, Mattheus M, von Eynatten M, Inker LA, Wanner C, Heerspink HJL. Short-Term Changes in Albuminuria and Risk of Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. J Am Heart Assoc. 2020 Sep 15;9(18):e016976. doi: 10.1161/JAHA.120.016976. Epub 2020 Sep 6.

name: Department of Clinical Pharmacy and Pharmacology University of GroningenUniversity Medical Center Groningen Groningen the Netherlands

name: National Clinical Research Center for Kidney Disease Nanfang Hospital Guangzhou China

name: Section of Endocrinology Yale University School of Medicine New Haven CT

name: Lunenfeld‐Tanenbaum Research InstituteMt Sinai HospitalUniversity of Toronto Ontario Canada

name: Department of Medicine Division of Nephrology Würzburg University Clinic Würzburg Germany

name: Tufts University School of MedicineTufts Medical Center Boston MA

title: Short‐Term Changes in Albuminuria and Risk of Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus: A Post Hoc Analysis of the EMPA‐REG OUTCOME Trial

ReferenceCitation: Böhm M, Fitchett D, Ofstad AP, Brueckmann M, Kaspers S, George JT, Zwiener I, Zinman B, Wanner C, Marx N, Mancia G, Anker SD, Mahfoud F. Heart failure and renal outcomes according to baseline and achieved blood pressure in patients with type 2 diabetes: results from EMPA-REG OUTCOME. J Hypertens. 2020 Sep;38(9):1829-1840. doi: 10.1097/HJH.0000000000002492.

ReferenceCitation: Inzucchi SE, Khunti K, Fitchett DH, Wanner C, Mattheus M, George JT, Ofstad AP, Zinman B. Cardiovascular Benefit of Empagliflozin Across the Spectrum of Cardiovascular Risk Factor Control in the EMPA-REG OUTCOME Trial. J Clin Endocrinol Metab. 2020 Sep 1;105(9). pii: dgaa321. doi: 10.1210/clinem/dgaa321.

name: Section of Endocrinology, Yale School of Medicine, New Haven, Connecticut

name: Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK

name: Division of Cardiology, St. Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada

name: Division of Nephrology, Würzburg University Clinic, Würzburg, Germany

name: Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim, Germany

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name: Boehringer Ingelheim Norway KS, Asker, Norway

name: Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada

journal_name: The Journal of Clinical Endocrinology & Metabolism

ReferenceCitation: Ferreira JP, Fitchett D, Ofstad AP, Kraus BJ, Wanner C, Zwiener I, Zinman B, Lauer S, George JT, Rossignol P, Zannad F. Empagliflozin for Patients With Presumed Resistant Hypertension: A Post Hoc Analysis of the EMPA-REG OUTCOME Trial. Am J Hypertens. 2020 Dec 31;33(12):1092-1101. doi: 10.1093/ajh/hpaa073.

name: Université de Lorraine, Centre d’Investigations Cliniques Plurithématique Inserm 1433, Nancy, France

name: CHRU de Nancy, Inserm U1116, Nancy, France

name: Division of Cardiology, St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada

name: Comprehensive Heart Failure Center, University of Würzburg, Würzburg, Germany

name: Department of Internal Medicine I, University Hospital Würzburg, Würzburg, Germany

name: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany

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

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ReferenceCitation: Perkovic V, Koitka-Weber A, Cooper ME, Schernthaner G, Pfarr E, Woerle HJ, von Eynatten M, Wanner C. Choice of endpoint in kidney outcome trials: considerations from the EMPA-REG OUTCOME® trial. Nephrol Dial Transplant. 2020 Dec 4;35(12):2103-2111. doi: 10.1093/ndt/gfz179.

name: The George Institute for Global Health, University of New South Wales, Sydney, Australia

name: Department of Diabetes, Central Clinical School, Monash University, Melbourne, Australia

name: Department of Medicine, Würzburg University Clinic, Würzburg, Germany

name: Rudolfstiftung Hospital Vienna, Department of Medicine, Vienna, Austria

title: Choice of endpoint in kidney outcome trials: considerations from the EMPA-REG OUTCOME® trial

ReferenceCitation: Kansal A, Reifsnider OS, Proskorovsky I, Zheng Y, Pfarr E, George JT, Kandaswamy P, Ruffolo A. Cost-effectiveness analysis of empagliflozin treatment in people with Type 2 diabetes and established cardiovascular disease in the EMPA-REG OUTCOME trial. Diabet Med. 2019 Nov;36(11):1494-1502. doi: 10.1111/dme.14076. Epub 2019 Jul 23.

name: Boehringer Ingelheim International Ingelheim am Rhein Germany

title: Cost‐effectiveness analysis of empagliflozin treatment in people with Type 2 diabetes and established cardiovascular disease in the EMPA ‐ REG OUTCOME trial

ReferenceCitation: Butler J, Zannad F, Fitchett D, Zinman B, Koitka-Weber A, von Eynatten M, Zwiener I, George J, Brueckmann M, Cheung AK, Wanner C. Empagliflozin Improves Kidney Outcomes in Patients With or Without Heart Failure. Circ Heart Fail. 2019 Jun;12(6):e005875. doi: 10.1161/CIRCHEARTFAILURE.118.005875. Epub 2019 Jun 5.

name: Department of Medicine, University of Mississippi Medical Center, Jackson (J.B.).

name: Institut Lorrain du Coeur et des Vaisseaux, Nancy, France (F.Z.).

name: Division of Cardiology, St Michael’s Hospital (D.F.), University of Toronto, Canada.

name: Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital (B.Z.), University of Toronto, Canada.

name: Boehringer Ingelheim International GmbH, Ingelheim, Germany (A.K.-W., M.v.E., J.G., M.B.).

name: Department of Diabetes, Central Clinical School, Monash University, Melbourne, Australia (A.K.-W.).

name: Department of Medicine, Würzburg University Clinic, Germany (A.K.-W., C.W.).

name: Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany (I.Z.).

name: Faculty of Medicine, University of Heidelberg, Mannheim, Germany (M.B.).

name: Division of Nephrology & Hypertension, University of Utah, Salt Lake City (A.K.C.).

title: Empagliflozin Improves Kidney Outcomes in Patients With or Without Heart Failure

ReferenceCitation: Verma S, Wanner C, Zwiener I, Ofstad AP, George JT, Fitchett D, Zinman B; EMPA-REG OUTCOME Investigators. Influence of Microvascular Disease on Cardiovascular Events in Type 2 Diabetes. J Am Coll Cardiol. 2019 Jun 4;73(21):2780-2782. doi: 10.1016/j.jacc.2019.03.002. Epub 2019 Mar 15.

title: Influence of Microvascular Disease on Cardiovascular Events in Type 2 Diabetes

ReferenceCitation: Januzzi J, Ferreira JP, Böhm M, Kaul S, Wanner C, Brueckmann M, Petrie MC, Ofstad AP, Zeller C, George J, Fitchett D, Zannad F. Empagliflozin reduces the risk of a broad spectrum of heart failure outcomes regardless of heart failure status at baseline. Eur J Heart Fail. 2019 Mar;21(3):386-388. doi: 10.1002/ejhf.1419. Epub 2019 Feb 14.

name: Cardiology DivisionMassachusetts General Hospital, Baim Institute for Clinical Research Boston MA USA

name: Centre d'Investigations Cliniques Plurithématique Inserm 1433Université de Lorraine Nancy France

name: CHRU de Nancy, Inserm U1116Université de Lorraine Nancy France

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name: Division of NephrologyWurzburg University Clinic Wurzburg Germany

name: Faculty of Medicine MannheimUniversity of Heidelberg Mannheim Germany

name: Department of Cardiology, Institute of Cardiovascular and Medical SciencesUniversity of Glasgow Glasgow UK

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ReferenceCitation: Fitchett D, Inzucchi SE, Cannon CP, McGuire DK, Scirica BM, Johansen OE, Sambevski S, Kaspers S, Pfarr E, George JT, Zinman B. Empagliflozin Reduced Mortality and Hospitalization for Heart Failure Across the Spectrum of Cardiovascular Risk in the EMPA-REG OUTCOME Trial. Circulation. 2019 Mar 12;139(11):1384-1395. doi: 10.1161/CIRCULATIONAHA.118.037778.

name: St Michael’s Hospital, Division of Cardiology, University of Toronto, Canada (D.F.).

name: Section of Endocrinology, Yale University School of Medicine, New Haven, CT (S.E.I.).

name: Cardiovascular Division, Brigham and Women’s Hospital, and Harvard Medical School, Boston, MA (C.P.C., B.M.S.).

name: University of Texas Southwestern Medical Center, Dallas (D.K.M.).

name: Boehringer Ingelheim Norway KS, Asker (O.E.J.).

name: Boehringer Ingelheim International GmbH, Ingelheim, Germany (S.S., S.K., E.P., J.T.G.).

name: Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Canada (B.Z.).

ReferenceCitation: Verma S, Mazer CD, Fitchett D, Inzucchi SE, Pfarr E, George JT, Zinman B. Empagliflozin reduces cardiovascular events, mortality and renal events in participants with type 2 diabetes after coronary artery bypass graft surgery: subanalysis of the EMPA-REG OUTCOME® randomised trial. Diabetologia. 2018 Aug;61(8):1712-1723. doi: 10.1007/s00125-018-4644-9. Epub 2018 May 19.

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.

ReferenceCitation: Inzucchi SE, Zinman B, Fitchett D, Wanner C, Ferrannini E, Schumacher M, Schmoor C, Ohneberg K, Johansen OE, George JT, Hantel S, Bluhmki E, Lachin JM. How Does Empagliflozin Reduce Cardiovascular Mortality? Insights From a Mediation Analysis of the EMPA-REG OUTCOME Trial. Diabetes Care. 2018 Feb;41(2):356-363. doi: 10.2337/dc17-1096. Epub 2017 Dec 4.

ReferenceCitation: Wanner C, Lachin JM, Inzucchi SE, Fitchett D, Mattheus M, George J, Woerle HJ, Broedl UC, von Eynatten M, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Clinical Outcomes in Patients With Type 2 Diabetes Mellitus, Established Cardiovascular Disease, and Chronic Kidney Disease. Circulation. 2018 Jan 9;137(2):119-129. doi: 10.1161/CIRCULATIONAHA.117.028268. Epub 2017 Sep 13.

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name: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany (M.M., J.G., H.J.W., U.C.B., M.v.E.)

name: Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada (B.Z.) and Division of Endocrinology, University of Toronto, Canada (B.Z.).

ReferenceCitation: Cherney DZI, Zinman B, Inzucchi SE, Koitka-Weber A, Mattheus M, von Eynatten M, Wanner C. Effects of empagliflozin on the urinary albumin-to-creatinine ratio in patients with type 2 diabetes and established cardiovascular disease: an exploratory analysis from the EMPA-REG OUTCOME randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2017 Aug;5(8):610-621. doi: 10.1016/S2213-8587(17)30182-1. Epub 2017 Jun 27.

ReferenceCitation: Zinman B, Inzucchi SE, Lachin JM, Wanner C, Fitchett D, Kohler S, Mattheus M, Woerle HJ, Broedl UC, Johansen OE, Albers GW, Diener HC; EMPA-REG OUTCOME Investigators (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients). Empagliflozin and Cerebrovascular Events in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk. Stroke. 2017 May;48(5):1218-1225. doi: 10.1161/STROKEAHA.116.015756. Epub 2017 Apr 6.

name: From the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada (B.Z.); Division of Endocrinology (B.Z.) and St Michael’s Hospital, Division of Cardiology (D.F.), University of Toronto, Canada; Section of Endocrinology, Yale University School of Medicine, New Haven, CT (S.E.I.); The Biostatistics Center, The George Washington University, Rockville, MD (J.M.L.); Comprehensive Heart Failure Center and Renal Division, University of Wuerzburg and Hospital, Germany (C.W.);...

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ReferenceCitation: Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, Mattheus M, Johansen OE, Woerle HJ, Broedl UC, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):323-34. doi: 10.1056/NEJMoa1515920. Epub 2016 Jun 14.

title: Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes

ReferenceCitation: Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.

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title: Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes

ReferenceCitation: Zinman B, Inzucchi SE, Lachin JM, Wanner C, Ferrari R, Fitchett D, Bluhmki E, Hantel S, Kempthorne-Rawson J, Newman J, Johansen OE, Woerle HJ, Broedl UC. Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™). Cardiovasc Diabetol. 2014 Jun 19;13:102. doi: 10.1186/1475-2840-13-102.

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title: A Phase III, Multicentre, International, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) Compared to Usual Care in Type 2 Diabetes Mellitus Patients With Increased Cardiovascular Risk

summary: The aim of the present study is to investigate the safety of BI 10773 treatment in patients with Type 2 Diabetes Mellitus and high cardiovascular risk.


type: EudraCT Number

title: Multimodal Therapy With and Without Cetuximab in Patients With Locally Advanced Esophageal Carcinoma - An Open-Label Phase III Trial

summary:
RATIONALE: Radiation therapy uses high-energy x-rays and to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving radiation therapy together with chemotherapy is more effective with or without cetuximab in treating patients with esophageal cancer.

PURPOSE: This randomized phase III trial is studying giving radiation therapy together with chemotherapy, with or without cetuximab, followed by surgery in treating patients with locally advanced esophageal cancer that can be removed by surgery.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Ruhstaller T, Thuss-Patience P, Hayoz S, Schacher S, Knorrenschild JR, Schnider A, Plasswilm L, Budach W, Eisterer W, Hawle H, Mariette C, Hess V, Mingrone W, Montemurro M, Girschikofsky M, Schmidt SC, Bitzer M, Bedenne L, Brauchli P, Stahl M; Swiss Group for Clinical Cancer Research (SAKK); German Esophageal Cancer Study Group; Austrian 'Arbeitsgemeinschaft Medikamentöse Tumortherapie' (AGMT); Fédération Francophone de Cancérologie Digestive (FFCD)/Fédération de Recherche en Chirurgie (FRENCH). Neoadjuvant chemotherapy followed by chemoradiation and surgery with and without cetuximab in patients with resectable esophageal cancer: a randomized, open-label, phase III trial (SAKK 75/08). Ann Oncol. 2018 Jun 1;29(6):1386-1393. doi: 10.1093/annonc/mdy105.

family: Ruhstaller

full_name: T. Ruhstaller

given: T.

family: Thuss-Patience

full_name: P. Thuss-Patience

given: P.

family: Hayoz

full_name: S. Hayoz

given: S.

family: Schacher

full_name: S. Schacher

family: Knorrenschild

full_name: J.R. Knorrenschild

family: Schnider

full_name: A. Schnider

given: A.

family: Plasswilm

full_name: L. Plasswilm

given: L.

family: Budach

full_name: W. Budach

given: W.

family: Eisterer

full_name: W. Eisterer

family: Hawle

full_name: H. Hawle

given: H.

family: Mariette

full_name: C. Mariette

given: C.

family: Hess

full_name: V. Hess

given: V.

family: Mingrone

full_name: W. Mingrone

family: Montemurro

full_name: M. Montemurro

given: M.

family: Girschikofsky

full_name: M. Girschikofsky

family: Schmidt

full_name: S.C. Schmidt

family: Bitzer

full_name: M. Bitzer

family: Bedenne

full_name: L. Bedenne

family: Brauchli

full_name: P. Brauchli

family: Stahl

full_name: M. Stahl

journal_name: Annals of Oncology

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

ReferenceCitation: Fehr M, Hawle H, Hayoz S, Thuss-Patience P, Schacher S, Riera Knorrenschild J, Dürr D, Knoefel WT, Rumpold H, Bitzer M, Zweifel M, Samaras P, Mey U, Küng M, Winterhalder R, Eisterer W, Hess V, Gérard MA, Templeton A, Stahl M, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK); German Esophageal Cancer Study Group; Austrian Arbeitsgemeinschaft Medikamentöse Tumortherapie (AGMT); Fédération Francophone de Cancérologie Digestive (FFCD) / Fédération de Recherche en Chirurgie (FRENCH). High thromboembolic event rate in patients with locally advanced oesophageal cancer during neoadjuvant therapy. An exploratory analysis of the prospective, randomised intergroup phase III trial SAKK 75/08. BMC Cancer. 2020 Feb 28;20(1):166. doi: 10.1186/s12885-020-6623-z.

name: for the Swiss Group for Clinical Cancer Research (SAKK)

name: the German Esophageal Cancer Study Group

name: the Austrian Arbeitsgemeinschaft Medikamentöse Tumortherapie (AGMT)

name: the Fédération Francophone de Cancérologie Digestive (FFCD) / Fédération de Recherche en Chirurgie (FRENCH)

location_country: Austria Switzerland France Hungary Germany

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Charite University Hospital - Campus Virchow Klinikum

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Centre Hospitalier Universitaire Vaudois


title: A Phase Ib/II Study of OBINUTUZUMAB Combined to LENALIDOMIDE for the Treatment of Follicular and Relapsed/Refractory Aggressive (DLBCL and MCL) B-cell Lymphoma

summary:
This study is to determine first the appropriate dose of lenalidomide to administer in combination with fixed doses of obinutuzumab in relapsed/refractory follicular lymphoma patients.

In a second step, this study aims to determine the efficacy of this combination in 3 separate populations: relapsed/refractory aggressive lymphoma (diffuse large B-cell lymphoma and mantle cell lymphoma: cohort 1), relapsed/refractory follicular lymphoma (cohort 2) and previously untreated follicular lymphoma (cohorts 3 and 4).

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Morschhauser F, Le Gouill S, Feugier P, Bailly S, Nicolas-Virelizier E, Bijou F, Salles GA, Tilly H, Fruchart C, Van Eygen K, Snauwaert S, Bonnet C, Haioun C, Thieblemont C, Bouabdallah R, Wu KL, Canioni D, Meignin V, Cartron G, Houot R. Obinutuzumab combined with lenalidomide for relapsed or refractory follicular B-cell lymphoma (GALEN): a multicentre, single-arm, phase 2 study. Lancet Haematol. 2019 Aug;6(8):e429-e437. doi: 10.1016/S2352-3026(19)30089-4. Epub 2019 Jul 8.

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

family: Feugier

full_name: Pierre Feugier

given: Pierre

family: Bailly

full_name: Sarah Bailly

given: Sarah

family: Nicolas-Virelizier

full_name: Emmanuelle Nicolas-Virelizier

given: Emmanuelle

family: Bijou

full_name: Fontanet Bijou

given: Fontanet

family: Salles

full_name: Gilles A Salles

given: Gilles A

family: Tilly

full_name: Hervé Tilly

given: Hervé

family: Fruchart

full_name: Christophe Fruchart

given: Christophe

family: Van Eygen

full_name: Koen Van Eygen

given: Koen

family: Snauwaert

full_name: Sylvia Snauwaert

given: Sylvia

family: Bonnet

full_name: Christophe Bonnet

family: Haioun

full_name: Corinne Haioun

given: Corinne

family: Thieblemont

full_name: Catherine Thieblemont

given: Catherine

family: Bouabdallah

full_name: Reda Bouabdallah

given: Reda

family: Wu

full_name: Ka Lung Wu

given: Ka Lung

family: Canioni

full_name: Danielle Canioni

given: Danielle

family: Meignin

full_name: Véronique Meignin

given: Véronique

family: Cartron

full_name: Guillaume Cartron

given: Guillaume

family: Houot

full_name: Roch Houot

given: Roch

journal_name: The Lancet Haematology

oa_host_type: repository

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

host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

ReferenceCitation: Morschhauser F, Salles G, Le Gouill S, Tilly H, Thieblemont C, Bouabdallah K, Fabiani B, Ménard C, Tarte K, Cartron G, Houot R. An open-label phase 1b study of obinutuzumab plus lenalidomide in relapsed/refractory follicular B-cell lymphoma. Blood. 2018 Oct 4;132(14):1486-1494. doi: 10.1182/blood-2018-05-853499. Epub 2018 Aug 1.

name: Service des Maladies du Sang, Centre Hospitalier Régional Universitaire de Lille, Groupe de Recherche sur les formes Injectables et les Technologies Associées, Université de Lille, Lille, France;

name: Hematology, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, University of Lyon, Pierre-Benite, France;

name: Department of Haematology, Centre Hospitalier Universitaire Nantes, Nantes, France;

name: Département d’Hématologie, U1245, Centre Henri Becquerel, Université de Rouen, Rouen, France;

name: Hemato-Oncology Department, Assistance Publique–Hôpitaux de Paris (AP-HP), INSERM U728, Hospital Saint-Louis, Institut Universitaire d’Hematologie, Paris, France;

name: Service d’Hématologie et de Thérapie Cellulaire, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France;

name: Hopital Saint-Antoine, AP-HP, Paris, France;

name: Unité Mixte de Recherche (UMR) S1236, INSERM, University of Rennes, Etablissement Français du Sang, Rennes, France;

name: Suivi Immunologique des Thérapeutiques Innovantes, Centre Hospitalier Universitaire de Rennes, Etablissement Français du Sang, Rennes, France;

name: UMR 5235, Centre Hospitalier Universitaire, University of Montpellier, Montpellier, France; and

name: Haematology Department, Centre Hospitalier Universitaire Rennes, Rennes, France

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - @rchiveSIC

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

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: AZ Groeninge - Campus Maria's Voorzienigheid

location_facility: Université Catholique de Louvain Mont Godinne

location_facility: Université Catholique de Louvain Saint Luc