title: A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Obinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia

ReferenceCitation: Stilgenbauer S, Bosch F, Ilhan O, Kisro J, Mahé B, Mikuskova E, Osmanov D, Reda G, Robinson S, Tausch E, Turgut M, Wójtowicz M, Böttcher S, Perretti T, Trask P, Van Hoef M, Leblond V, Foà R. Safety and efficacy of obinutuzumab alone or with chemotherapy in previously untreated or relapsed/refractory chronic lymphocytic leukaemia patients: Final analysis of the Phase IIIb GREEN study. Br J Haematol. 2021 Apr;193(2):325-338. doi: 10.1111/bjh.17326. Epub 2021 Feb 19.

ReferenceCitation: Bosch F, Cantin G, Cortelezzi A, Knauf W, Tiab M, Turgut M, Zaritskey A, Merot JL, Tausch E, Trunzer K, Robson S, Gresko E, Böttcher S, Foà R, Stilgenbauer S, Leblond V. Obinutuzumab plus fludarabine and cyclophosphamide in previously untreated, fit patients with chronic lymphocytic leukemia: a subgroup analysis of the GREEN study. Leukemia. 2020 Feb;34(2):441-450. doi: 10.1038/s41375-019-0554-1. Epub 2019 Aug 27.

ReferenceCitation: Stilgenbauer S, Leblond V, Foà R, Böttcher S, Ilhan O, Knauf W, Mikuskova E, Renner C, Tausch E, Woszczyk D, Gresko E, Lundberg L, Moore T, Morris T, Robson S, Bosch F. Obinutuzumab plus bendamustine in previously untreated patients with CLL: a subgroup analysis of the GREEN study. Leukemia. 2018 Aug;32(8):1778-1786. doi: 10.1038/s41375-018-0146-5. Epub 2018 Apr 27.

location_country:
Serbia
Spain
Italy
Lithuania
Belgium
Romania
Poland
Portugal
Slovenia
Russian Federation
Argentina
Israel
Turkey
Mexico
Sweden
Slovakia
Egypt
Bosnia and Herzegovina
Brazil
Canada
Switzerland
North Macedonia
Germany
Greece
Ireland
Estonia
Latvia
Finland
Thailand
Korea, Republic of
France

location_facility: Vladimirskiy Regional Scientific Research Inst. ; Hematology

location_facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: Istituto Oncologico della Svizzera Italiana (IOSI)

location_facility: Siriraj Hospital; Division of Hematology, Department of Medicine

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Hopital Robert Debre; Hematologie Clinique

location_facility: Hospital Universitario Reina Sofia; Servicio de Hematologia

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Hospital General De Culiacan; Servicio De Hematologia

location_facility: Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center

location_facility: Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie

location_facility: Fakultna Nemocnica Roosevelta; Dept. of Haematology

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: Soroka Medical Center; Hematology Deptartment

location_facility: Ospedale Cardarelli; Divisione Di Ematologia

location_facility: Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia

location_facility: Ramathibodi Hospital; Division of Hematology, Department of Medicine

location_facility: RECUH, Oncology Centre of Latvia; Clinic of Chemotherapy and Heamatology

location_facility: Universitetssjukhuset i Linköping, Hematologkliniken

location_facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

location_facility: Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Laiko General Hospital; Hematology Clinic

location_facility: Gemeinschaftspraxis; Prof. Dr. Michael Kiehl und Dr.med. Wolfgang Stein

location_facility: Georgios Papanikolaou Hospital; Hematology Department

location_facility: Ichilov Sourasky Medical Center; Heamatology

location_facility: Onkologische Schwerpunktpraxis Dres. Rudolf Schlag und Björn Schöttker

location_facility: Ospedale Molinette - Universita' Di Torino; Cliniche Universitarie Ematologia I

location_facility: Centre Hospitalier René Dubos; Hematologie

location_facility: Hospital das Clinicas - FMUSP; Hematologia

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

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

location_facility: Spitalul Clinic Coltea; Clinica de Hematologie

location_facility: Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin

location_facility: University Clinical Center Sarajevo, Clinic for Hematology

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine

location_facility: Hadassah Ein Karem Hospital; Haematology

location_facility: Hopital Saint Eloi; Hematologie Oncologie Medicale

location_facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura

location_facility: Az. Osp. Pugliese; Divisione de Ematologia

location_facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

location_facility: Cairo University Hospital Al Kasr El Ainy

location_facility: Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia

location_facility: Bnei-Zion Medical Center; Hematology Dept

location_facility: Azienda ospedaliera oo rr di foggi; Hematology

location_facility: Hospital Sirio Libanes; Centro de Oncologia

location_facility: Schwerpunktpraxis & Tagesklinik f. Hämatologie & Onkologie Regensdorf / Schwandorf / Wörth

location_facility: Spitalul Clinic Judetean de Urgenta Brasov; Clinica de Hematologie

location_facility: Ondokuzmayis University Medical Faculty Heamatology Department

location_facility: Azienda USL 6 Livorno - P.O. Livorno; U.O. Ematologia Clinica

location_facility: University Hospital of Ioannina; Hematology

location_facility: Hospital Estadual do Servidor Publico; Hematologia

location_facility: Hospital De Txagorritxu; Servicio de Hematologia

location_facility: Ospedale Vito Fazzi; Div. Oncoematologia

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Arcispedale S. Anna; Sezione Di Ematologia

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

location_facility: Hospital Infanta Leonor; Servicio de Hematologia

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny

location_facility: Karadeniz Technical Uni School of Medicine; Hematology

location_facility: Regional health authority A vitalite health network

location_facility: Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula

location_facility: Clinical Center Ljubljana; Haematology Dept

location_facility: Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Hematología

location_facility: Hopital Pitie Salpetriere; Hematologie Clinique

location_facility: Centro de Estudios Clinicos de Queretaro (CECLIQ)

location_facility: University Clinic of Hematology Skopje, Hospital Care Department

location_facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

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

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin

location_facility: Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: IPO do Porto; Servico de Onco-Hematologia

location_facility: King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine

location_facility: Waterford Regional Hospital; Department Of Medical Oncology

location_facility: Dres. Hans-Dieter Schick Dorothea Schick Burkhard Schmidt u.w.

location_facility: Gaziantep University Medical School; Hematology

location_facility: AUSL di Piacenza - Ospedale "Guglielmo da Saliceto";U.O. Ematologia

location_facility: Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi

location_facility: National Oncology Inst. ; Dept. of Haematology

location_facility: CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie

location_facility: Centre de sante et de services sociaux Rimouski Neigette

location_facility: Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll

location_facility: North Estonia Regional Hospital; Hematology

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej

location_facility: Hospital Quiron de Madrid; Servicio de Hematologia

location_facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: A.O. Universitaria Policlinico Di Modena; Ematologia

location_facility: Turku Uni Central Hospital; Dept of Internal Medicine

location_facility: General Hospital of Athens Evangelismos; Hematology

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter

location_facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: Centro Medico Nacional Sxxi - Imss; Haematology

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: Almazov Federal Heart, Blood and Endocrinilogy Centre; Hematology department

location_facility: Hospital San Pedro De Alcantara; Servicio de Hematologia

location_facility: University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept

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

location_facility: Hopital Cote De Nacre; Hematologie Biologique

location_facility: Hopital Saint Antoine; Hematologie Clinique

location_facility: Onkologisches Zentrum am Bethanien-Kankenhaus

location_facility: Uni Degli Studi Di Genova; 1A Divisione Di Ematologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders

location_facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia

summary: This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.


type: Other Identifier

title: A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients

acronym: TERI-PRO

summary:
Primary Objective:

To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs).

Secondary Objectives:

To describe disease progression using PROs. To describe clinical outcomes (ie, treated relapses) in teriflunomide treated participant.

To describe the change in cognition in teriflunomide treated participants. To describe safety of teriflunomide in participant treated (based on adverse events reporting).

To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment.

To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Coyle PK, Khatri B, Edwards KR, Meca-Lallana JE, Cavalier S, Rufi P, Benamor M, Poole EM, Robinson M, Gold R. Teriflunomide real-world evidence: Global differences in the phase 4 Teri-PRO study. Mult Scler Relat Disord. 2019 Jun;31:157-164. doi: 10.1016/j.msard.2019.03.022. Epub 2019 Mar 30.

ReferenceCitation: Coyle PK, Khatri B, Edwards KR, Meca-Lallana JE, Cavalier S, Rufi P, Benamor M, Brette S, Robinson M, Gold R; Teri-PRO Trial Group. Patient-reported outcomes in relapsing forms of MS: Real-world, global treatment experience with teriflunomide from the Teri-PRO study. Mult Scler Relat Disord. 2017 Oct;17:107-115. doi: 10.1016/j.msard.2017.07.006. Epub 2017 Jul 6.

lead_sponsor: Sanofi

location_country:
Spain
Greece
Austria
Italy
United Kingdom
Canada
Finland
Sweden
United States
Chile
France
Belgium
Norway
Germany

location_facility:
Investigational Site Number 056002
Investigational Site Number 840114
Investigational Site Number 840058
Investigational Site Number 840012
Investigational Site Number 840028
Investigational Site Number 840040
Investigational Site Number 250021
Investigational Site Number 152005
Investigational Site Number 840030
Investigational Site Number 840094
Investigational Site Number 840044
Investigational Site Number 826-009
Investigational Site Number 840091
Investigational Site Number 056005
Investigational Site Number 840098
Investigational Site Number 840053
Investigational Site Number 840055
Investigational Site Number 250026
Investigational Site Number 826-007
Investigational Site Number 826-005
Investigational Site Number 724005
Investigational Site Number 250032
Investigational Site Number 840024
Investigational Site Number 840077
Investigational Site Number 840018
Investigational Site Number 578003
Investigational Site Number 840045
Investigational Site Number 056007
Investigational Site Number 724004
Investigational Site Number 250007
Investigational Site Number 300005
Investigational Site Number 246005
Investigational Site Number 250004
Investigational Site Number 724008
Investigational Site Number 840076
Investigational Site Number 124006
Investigational Site Number 250005
Investigational Site Number 040-002
Investigational Site Number 250001
Investigational Site Number 250038
Investigational Site Number 840080
Investigational Site Number 250003
Investigational Site Number 840100
Investigational Site Number 250012
Investigational Site Number 840059
Investigational Site Number 840104
Investigational Site Number 250035
Investigational Site Number 840084
Investigational Site Number 840070
Investigational Site Number 056009
Investigational Site Number 040-001
Investigational Site Number 826-003
Investigational Site Number 250022
Investigational Site Number 840064
Investigational Site Number 724010
Investigational Site Number 246001
Investigational Site Number 826-010
Investigational Site Number 840032
Investigational Site Number 276003
Investigational Site Number 250037
Investigational Site Number 826-001
Investigational Site Number 250033
Investigational Site Number 752002
Investigational Site Number 840046
Investigational Site Number 840026
Investigational Site Number 250024
Investigational Site Number 250023
Investigational Site Number 840002
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Investigational Site Number 840003
Investigational Site Number 250017
Investigational Site Number 246006
Investigational Site Number 276001
Investigational Site Number 840014
Investigational Site Number 840105
Investigational Site Number 840078
Investigational Site Number 152003
Investigational Site Number 250030
Investigational Site Number 246003
Investigational Site Number 840037
Investigational Site Number 840041
Investigational Site Number 840073
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Investigational Site Number 840048
Investigational Site Number 250039
Investigational Site Number 380009
Investigational Site Number 840086
Investigational Site Number 840020
Investigational Site Number 152001
Investigational Site Number 250008
Investigational Site Number 380006
Investigational Site Number 250020
Investigational Site Number 840107
Investigational Site Number 250028
Investigational Site Number 276004
Investigational Site Number 578002
Investigational Site Number 840087
Investigational Site Number 840060
Investigational Site Number 840042
Investigational Site Number 840038
Investigational Site Number 840007
Investigational Site Number 056008
Investigational Site Number 250011
Investigational Site Number 840011
Investigational Site Number 250040
Investigational Site Number 840097
Investigational Site Number 840072
Investigational Site Number 840068
Investigational Site Number 724006
Investigational Site Number 380004
Investigational Site Number 840090
Investigational Site Number 250025
Investigational Site Number 840089
Investigational Site Number 840075
Investigational Site Number 250018
Investigational Site Number 752003
Investigational Site Number 056006
Investigational Site Number 380008
Investigational Site Number 250016
Investigational Site Number 840069
Investigational Site Number 840017
Investigational Site Number 250009
Investigational Site Number 724007
Investigational Site Number 840056
Investigational Site Number 840016
Investigational Site Number 250029
Investigational Site Number 250043
Investigational Site Number 250031
Investigational Site Number 380002
Investigational Site Number 752001
Investigational Site Number 826-008
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Investigational Site Number 840008
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Investigational Site Number 300002
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Investigational Site Number 250002
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Investigational Site Number 246004
Investigational Site Number 840112
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 840009
Investigational Site Number 250019
Investigational Site Number 840081
Investigational Site Number 578001
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Investigational Site Number 724001
Investigational Site Number 840010
Investigational Site Number 124007
Investigational Site Number 300004
Investigational Site Number 250027
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Investigational Site Number 056001
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Investigational Site Number 056003
Investigational Site Number 840108
Investigational Site Number 840005
Investigational Site Number 250015
Investigational Site Number 380005

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)

acronym: AEGEAN

summary: The study purpose is to assess the impact of an educational program on patient adherence in patients taking Apixaban for SPAF at 24 weeks

study_start_date_type: Actual

design_allocation: Randomized

primary_purpose: Other

ReferenceCitation: Montalescot G, Brotons C, Cosyns B, Crijns HJ, D'Angelo A, Drouet L, Eberli F, Lane DA, Besse B, Chan A, Vicaut E, Darius H; AEGEAN Study Investigators. Educational Impact on Apixaban Adherence in Atrial Fibrillation (the AEGEAN STUDY): A Randomized Clinical Trial. Am J Cardiovasc Drugs. 2020 Feb;20(1):61-71. doi: 10.1007/s40256-019-00356-2.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
Switzerland
France
Belgium
Germany


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients

summary: The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

ReferenceCitation: Grand J, Miger K, Sajadieh A, Køber L, Torp-Pedersen C, Ertl G, López-Sendón J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.

ReferenceCitation: Matsue Y, Sama IE, Postmus D, Metra M, Greenberg BH, Cotter G, Davison BA, Felker GM, Filippatos G, Pang P, Ponikowski P, Severin T, Gimpelewicz C, Voors AA, Teerlink JR. Association of Early Blood Pressure Decrease and Renal Function With Prognosis in Acute Heart Failure. JACC Heart Fail. 2021 Dec;9(12):890-903. doi: 10.1016/j.jchf.2021.07.001. Epub 2021 Oct 6.

ReferenceCitation: Grand J, Miger K, Sajadieh A, Køber L, Torp-Pedersen C, Ertl G, López-Sendón J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.

ReferenceCitation: Loungani RS, Teerlink JR, Metra M, Allen LA, Butler J, Carson PE, Chen CW, Cotter G, Davison BA, Eapen ZJ, Filippatos GS, Gimpelewicz C, Greenberg B, Holbro T, Januzzi JL Jr, Lanfear DE, Pang PS, Piña IL, Ponikowski P, Miller AB, Voors AA, Felker GM. Cause of Death in Patients With Acute Heart Failure: Insights From RELAX-AHF-2. JACC Heart Fail. 2020 Dec;8(12):999-1008. doi: 10.1016/j.jchf.2020.09.010. Epub 2020 Nov 11.

ReferenceCitation: Metra M, Teerlink JR, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Pang PS, Ponikowski P, Voors AA, Adams KF, Anker SD, Arias-Mendoza A, Avendaño P, Bacal F, Böhm M, Bortman G, Cleland JGF, Cohen-Solal A, Crespo-Leiro MG, Dorobantu M, Echeverría LE, Ferrari R, Goland S, Goncalvesová E, Goudev A, Køber L, Lema-Osores J, Levy PD, McDonald K, Manga P, Merkely B, Mueller C, Pieske B, Silva-Cardoso J, Špinar J, Squire I, Stępińska J, Van Mieghem W, von Lewinski D, Wikström G, Yilmaz MB, Hagner N, Holbro T, Hua TA, Sabarwal SV, Severin T, Szecsödy P, Gimpelewicz C; RELAX-AHF-2 Committees Investigators. Effects of Serelaxin in Patients with Acute Heart Failure. N Engl J Med. 2019 Aug 22;381(8):716-726. doi: 10.1056/NEJMoa1801291.

ReferenceCitation: Teerlink JR, Voors AA, Ponikowski P, Pang PS, Greenberg BH, Filippatos G, Felker GM, Davison BA, Cotter G, Gimpelewicz C, Boer-Martins L, Wernsing M, Hua TA, Severin T, Metra M. Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX-AHF-2 study. Eur J Heart Fail. 2017 Jun;19(6):800-809. doi: 10.1002/ejhf.830. Epub 2017 Apr 28.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Ireland
France
Chile
Colombia
Netherlands


title: Efficacy of Alternating Immunochemotherapy Consisting of R-CHOP + R-HAD vs R-CHOP Alone, Followed by Maintenance Therapy Consisting of Additional Lenalidomide + Rituximab vs Rituximab Alone for Older Patients With Mantle Cell Lymphoma

summary:
This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance improves progression free survival (PFS) compared to standard rituximab maintenance after induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60 year old) with mantle cell lymphoma.

The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28 alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab).

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Poland Portugal Spain Netherlands France Belgium Germany

location_facility: Gemeinschaftspraxis für Hämatologie und internistische Onkologie

location_facility: Gemeinschaftspraxis für Innere Medizin, Hämatologie und internistische Onkologie

location_facility: Institut Catala d'Oncologia (ICO) - Hospital Germans Trias y Pujol

location_facility: Uni-Klinikum-Schleswig-Holstein im Städt. Krankenhaus Kiel

location_facility: Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)

location_facility: Internistische Praxis /Hämatologie und Onkologie

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Université Catholique de Louvain Saint Luc

location_facility: Instituto Português de Oncologia de Lisboa de Francisco Gentil

location_facility: DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Charite´ Universitätsmedizin Berlin Campus Benjamin Franklin

location_facility: Institute of Hematology and Transfusiology

location_facility: Université Catholique de Louvain Mont Godinne

location_facility: Charite´Universitätsmedizin Berlin Campus Virchow-Klinikum

location_facility: Hospital Universitario Central de Asturias

status_simplified: Ongoing


title: A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura)

summary: Evaluation of headache response at 2 hours for active treated attacks for increasing dose.

ReferenceCitation: Almas M, Tepper SJ, Landy S, Schweizer E, Ramos E. Consistency of eletriptan in treating migraine: Results of a randomized, within-patient multiple-dose study. Cephalalgia. 2014 Feb;34(2):126-35. doi: 10.1177/0333102413500726. Epub 2013 Aug 14.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country: Denmark Portugal Spain Greece Italy Netherlands Sweden Hungary France Turkey Belgium Norway Germany Czechia

location_facility: Hospital Universitari de Lleida Arnau de Vilanova

location_facility: Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)

location_facility: Hospital General Universitari Vall D�Hebron

location_facility: Fondazione Istituto Neurologico Casimiro Mondino Istituto Di Ricovero E Cura A Carattere Scientifico

location_facility: University of Debrecen, Medical and Health Science Centre, Medical School

location_facility: Karadeniz Technical University Medical Faculty

location_facility: Hospital General Universitario J. M. Morales Meseguer

location_facility: Universita Degli Studi Di Modena-Policlinico Dipartimento Di Medicina Interna

location_facility: Clinica Neurologica, Universita Di Perugia

location_facility: Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)

location_facility: Universita' Degli Studi Di Cagliari - Presidio Osp.S.Giovanni Di Dio

location_facility: 1St Medical Faculty of the Charles University

location_facility: Fachklinik Fuer Neurologie Dietenbronn Gmbh


ipd_sharing: Yes

title: A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma

lead_sponsor: Millennium Pharmaceuticals, Inc.

type: Registry Identifier

source: euctr

ReferenceCitation: Facon T, Venner CP, Bahlis NJ, Offner F, White DJ, Karlin L, Benboubker L, Rigaudeau S, Rodon P, Voog E, Yoon SS, Suzuki K, Shibayama H, Zhang X, Twumasi-Ankrah P, Yung G, Rifkin RM, Moreau P, Lonial S, Kumar SK, Richardson PG, Rajkumar SV. Oral ixazomib, lenalidomide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2021 Jul 1;137(26):3616-3628. doi: 10.1182/blood.2020008787.

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.

location_country:
Russian Federation
New Zealand
Canada
Korea, Republic of
United States
France
Belgium

summary: The purpose of this study is to provide continued access to ixazomib and/or lenalidomide to participants who are continuing to have clinical benefit and to continue collecting relevant safety data to monitor safety in participants with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.


title: The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum

summary: The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician's choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study.

ReferenceCitation: Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. doi: 10.1200/JCO.20.01164. Epub 2020 Aug 21.

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.

lead_sponsor: Pfizer

location_country:
Denmark
Poland
Spain
Ireland
Austria
Australia
Italy
Canada
Finland
Netherlands
United Kingdom
Sweden
Hungary
United States
France
Belgium
Norway
Germany
Czechia

location_facility: Istituto Nazionale Tumori di Napoli, "G.Pascale" , Oncologia Medica, Dipartimento Uro-Ginecologico

location_facility: Centre Hospitalier de l'Universite de Montreal (Chum) - Hopital Notre-Dame

location_facility: Fundacion IVO-Instituto Valenciano de Oncologia

location_facility: NCT Nationales Centrum für Tumorerkrankungen Heidelberg

location_facility: Mater Misericordiae Health Services Brisbane Limited

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: UCLA Hematology/Oncology Clinic - Santa Monica

location_facility: Admin.Office/Study Supplies Mailing Address: UCLA Medicine Hematology-Oncology

location_facility: Universita degli Studi Federico II di Napoli Oncologia Medica

location_facility: British Columbia Cancer Agency - Vancouver Centre

location_facility: Associated Vitreoretinal and Uveitis Consultants

location_facility: Dipartimento di Scienze Chirurgiche per le Patologie della Testa e del Collo - UOC di Oculistica

location_facility: Institut Paoli Calmettes - Departement d'Oncologie Medicale

location_facility: SSD Oncologia Medica Addarii-Zamagni - Policlinico S. Orsola-Malpighi

location_facility: Azienda Ospedaliera Sant' Andrea - Unita Operativa Semplice di Patologia Vitreo-Retinica

location_facility: UCLA Hematology Oncology Clinic Santa Clarita

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: University of Cincinnati Physicians Company

location_facility: Ospedale Santa Maria delle Croci - Unita Operativa di Oncologia

location_facility: University of Colorado Denver, University of Colorado Cancer Center

location_facility: University Medical Center Groningen, Medical Oncology

location_facility: Ospedale Civile degli Infermi - Servizio di Oculistica

location_facility: Azienda Ospedaliera Vincenzo Monaldi di Napoli - U.O.C. di Oculistica

location_facility: UT Southwestern Medical Center-Zale Lipshy University Hospital

location_facility: Clinique et Maternite Sainte-Elisabeth Namur

location_facility: Ospedale Umberto I - Unita Operativa di Oncologia

location_facility: Ophthalmology at Instituto Oftalmologico Integral

location_facility: Policlinico Umberto I - Università Sapienza

location_facility: UCLA Hematology - Oncology Clinic - Westlake Village

location_facility: Universita degli Studi Federico II di Napoli Dipartimento di Neuroscienze Scienze

location_facility: Montefiore Medical Center, Green Medical Arts Pavilion

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Montefiore Medical Center - Centennial Women's Health

location_facility: Klinik fur Frauenheilkunde und Geburtshilfe

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: UT Southwestern Medical Center-Clements University Hospital

location_facility: Orszagos Onkologiai Intezet Kozponti Aneszteziologiai es Intenzivterapias Osztaly

location_facility: Istituto Nazionale Tumori Regina Elena - Oncologia Medica A

location_facility: Radiology at Centro Medico Sanitas Ressalta

location_facility: Fairview Hospital Moll Pavilion Cancer Center

location_facility: Ospedale San Raffaele - Unita Operativa di Oculistica

location_facility: Hospital de Sant Joan Despi Moises Broggi

location_facility: Stephenson Cancer Center(clinic location)

location_facility: St. Vincent Hospital and Health Care Center, Inc.

location_facility: Struttura Complessa di Oftalmologia Policlinico S. Orsola-Malpighi

location_facility: Ospedale Civile degli Infermi - Unita Operativa di Oncologia Medica

location_facility: University of California Los Angeles, Hematology-Oncology Clinic

location_facility: James Cancer Hospital & Solove Research Institute

location_facility: University of Iowa Hospitals and Clinics

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Avd. for gynekologisk kreft, Radiumhospitalet

location_facility: Juravinski Cancer Center, Department of Oncology

location_facility: Azienda Opsedaliera S. Maria Degli Angeli Pordenone-Dipartimento di Chirurgia Specialistica -

location_facility: Stefanie Spielman Comprehensive Breast Cancer

location_facility: Radiology at Hospital Univeristari de Bellvitge

location_facility: University of California, Irvine/UC Irvine Health

location_facility: Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly

location_facility: Centre d'Ophtalmologie du LEZ Centre Medical Les Roques

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly

location_facility: Spedali Civili di Brescia - Struttura Complessa Clinicizzata - U.O.di Oculistica

location_facility: Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology

location_facility: Institut de Cancerologie de I'Ouest - Rene Gauducheau

location_facility: Centro di Riferimento Oncologico - Struttura Operativa Complessa (SOC)- Oncologia Medica C

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori - SC Oncologia Ginecologica

location_facility: Montefiore Medical Center - Einstein Center for Cancer Care

location_facility: Ophthalmology at Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Semmelweis Egyetem AOK Szemeszeti Klinika

location_facility: Instituto de Oftalmologia y Hospital La Arruzafa

location_facility: Hospital Universitario Reina Sofía/ Provincial

location_facility: Ospedale Santa Maria delle Croci - Oculistica

location_facility: Georgia Regents University Cancer Center


title: A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

summary: Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin.

ReferenceType: result

ReferenceCitation: Pfisterer J, Shannon CM, Baumann K, Rau J, Harter P, Joly F, Sehouli J, Canzler U, Schmalfeldt B, Dean AP, Hein A, Zeimet AG, Hanker LC, Petit T, Marmé F, El-Balat A, Glasspool R, de Gregorio N, Mahner S, Meniawy TM, Park-Simon TW, Mouret-Reynier MA, Costan C, Meier W, Reinthaller A, Goh JC, L'Haridon T, Baron Hay S, Kommoss S, du Bois A, Kurtz JE; AGO-OVAR 2.21/ENGOT-ov 18 Investigators. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 May;21(5):699-709. doi: 10.1016/S1470-2045(20)30142-X. Epub 2020 Apr 16. Erratum in: Lancet Oncol. 2022 Jun;23(6):e248.

lead_sponsor: AGO Research GmbH

location_country:
United Kingdom
Austria
Australia
France
Belgium
Germany

location_facility: Schwerpunktpraxis für Onkologie / Hämatologie

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Hôpital Michallon, Centre Hospitalier Universitaire de Grenoble

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Clinique Mutualiste de l'Estuaire, Cité Sanitaire

location_facility: The Beatson West of Scotland Cancer Center

location_facility: Klinikum Schaumburg, Krankenhaus Stadthagen

location_facility: SALK-LKH Salzburg, Universitätsklinik für Frauenheilkunde und Geburtshilfe

location_facility: Hôpital Privé Villeneuve d'Ascq, Institut de Canérologie

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck

location_facility: MUG-Universitätsklinik für Frauenheilkunde Graz

intervention_type: Biological


title: A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients With Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as Intermediate or High Risk by a 14-Gene Prognostic Assay

summary: The optimal treatment for Stage I or Stage IIA non-small cell lung cancer (NSCLC) remains controversial. Radiographic surveillance alone has been recommended for stage I and stage IIA patients after the tumor is removed surgically from the lung, and this standard has been based on the fact that no previous clinical trial has demonstrated a benefit for Stage I or Stage IIA NSCLC patients who receive post-operative chemotherapy. These patients, however, have a substantial risk of death within five years after operation, ranging from approximately 30% to 45%, largely due to metastatic disease that is present immediately after surgery but that is undetectable by conventional methods. Some leading organizations therefore currently recommend post-operative chemotherapy as an alternative standard of care in Stage I or Stage IIA NSCLC patients who are considered to be at particularly high-risk. Up until now, however, there has not been a well-validated means to identify stage I and stage IIA NSCLC patients at high risk of death within five years after operation. A new prognostic tool, a 14-Gene Prognostic Assay, which has been validated and definitively demonstrated in large scale studies to identify intermediate and high-risk stage I or Stage IIA patients with non-squamous NSCLC, is now available to all clinicians through a CLIA-certified laboratory. It is therefore now possible to compare the outcomes of patients randomly assigned to one or the other of these competing standards of care.

status: Recruiting

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Kratz JR, He J, Van Den Eeden SK, Zhu ZH, Gao W, Pham PT, Mulvihill MS, Ziaei F, Zhang H, Su B, Zhi X, Quesenberry CP, Habel LA, Deng Q, Wang Z, Zhou J, Li H, Huang MC, Yeh CC, Segal MR, Ray MR, Jones KD, Raz DJ, Xu Z, Jahan TM, Berryman D, He B, Mann MJ, Jablons DM. A practical molecular assay to predict survival in resected non-squamous, non-small-cell lung cancer: development and international validation studies. Lancet. 2012 Mar 3;379(9818):823-32. doi: 10.1016/S0140-6736(11)61941-7. Epub 2012 Jan 27.

ReferenceCitation: Woodard GA, Wang SX, Kratz JR, Zoon-Besselink CT, Chiang CY, Gubens MA, Jahan TM, Blakely CM, Jones KD, Mann MJ, Jablons DM. Adjuvant Chemotherapy Guided by Molecular Profiling and Improved Outcomes in Early Stage, Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Jan;19(1):58-64. doi: 10.1016/j.cllc.2017.05.015. Epub 2017 May 31.

ReferenceCitation: Kratz JR, Van den Eeden SK, He J, Jablons DM, Mann MJ. A prognostic assay to identify patients at high risk of mortality despite small, node-negative lung tumors. JAMA. 2012 Oct 24;308(16):1629-31. doi: 10.1001/jama.2012.13551.

lead_sponsor: Razor Genomics

location_country:
Germany
United States
France

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Allegheny Health Network Research Institute

location_facility: Providence Medical Foundation Santa Rosa

location_facility: Lung Clinic Grosshansdorf-Department of Thoracic Oncology

location_facility: Groupe Hospitalier Région de Mulhouse Sud -Alsace

location_facility: Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg

location_facility: Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH - Universitätsklinik -

location_facility: Munich-Gauting -Thoracic Oncology Department Asklepios Lung Clinic

location_facility: Centre Hospitalier Intercommunal de Créteil

intervention_type: Other


title: Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe

summary: This non-interventional retrospective medical record review study will assess the prevalence of KRAS testing and the impact of the KRAS test result on patterns of Vectibix use in patients with metastatic colorectal cancer (mCRC) treated with Vectibix in selected European countries over 3 rounds. As the optimal use of Vectibix also requires accurate KRAS mutation testing, this study will also assess data from the laboratory that performed the KRAS test. The study will also monitor changes in the pattern of Vectibix treatment between the different rounds of the study.

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Han van Krieken J, Kafatos G, Bennett J, Mineur L, Tomasek J, Rouleau E, Fabian P, De Maglio G, Garcia-Alfonso P, Aprile G, Parkar P, Downey G, Demonty G, Trojan J. Panitumumab use in metastatic colorectal cancer and patterns of RAS testing: results from a Europe-wide physician survey and medical records review. BMC Cancer. 2017 Nov 28;17(1):798. doi: 10.1186/s12885-017-3740-4.

lead_sponsor: Amgen

location_country: Denmark Spain Italy Netherlands Sweden France Belgium Germany Czechia


ipd_sharing: Undecided

acronym: RESORCE

title: A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study of Regorafenib in Patients With Hepatocellular Carcinoma (HCC) After Sorafenib

lead_sponsor: Bayer

ReferenceCitation: Finn RS, Merle P, Granito A, Huang YH, Bodoky G, Pracht M, Yokosuka O, Rosmorduc O, Gerolami R, Caparello C, Cabrera R, Chang C, Sun W, LeBerre MA, Baumhauer A, Meinhardt G, Bruix J. Outcomes of sequential treatment with sorafenib followed by regorafenib for HCC: Additional analyses from the phase III RESORCE trial. J Hepatol. 2018 Aug;69(2):353-358. doi: 10.1016/j.jhep.2018.04.010. Epub 2018 Apr 26.

ReferenceCitation: Bruix J, Qin S, Merle P, Granito A, Huang YH, Bodoky G, Pracht M, Yokosuka O, Rosmorduc O, Breder V, Gerolami R, Masi G, Ross PJ, Song T, Bronowicki JP, Ollivier-Hourmand I, Kudo M, Cheng AL, Llovet JM, Finn RS, LeBerre MA, Baumhauer A, Meinhardt G, Han G; RESORCE Investigators. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Jan 7;389(10064):56-66. doi: 10.1016/S0140-6736(16)32453-9. Epub 2016 Dec 6. Erratum in: Lancet. 2017 Jan 7;389(10064):36.

ReferenceCitation: Teufel M, Seidel H, Köchert K, Meinhardt G, Finn RS, Llovet JM, Bruix J. Biomarkers Associated With Response to Regorafenib in Patients With Hepatocellular Carcinoma. Gastroenterology. 2019 May;156(6):1731-1741. doi: 10.1053/j.gastro.2019.01.261. Epub 2019 Feb 6.

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Austria
Australia
Russian Federation
Argentina
Singapore
Brazil
Switzerland
Hungary
China
Germany
Taiwan
Korea, Republic of
France
Netherlands

summary: The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.


title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab (AMG 145) is Used in Combination With Statin Therapy In Patients With Clinically Evident Cardiovascular Disease

acronym: FOURIER

summary: The primary objective was to evaluate the effect of treatment with evolocumab, compared with placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with clinically evident cardiovascular disease.

ReferenceCitation: Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.

ReferenceCitation: Fonarow GC, Keech AC, Pedersen TR, Giugliano RP, Sever PS, Lindgren P, van Hout B, Villa G, Qian Y, Somaratne R, Sabatine MS. Cost-effectiveness of Evolocumab Therapy for Reducing Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2017 Oct 1;2(10):1069-1078. doi: 10.1001/jamacardio.2017.2762. Erratum in: JAMA Cardiol. 2017 Oct 1;2(10):1170.

ReferenceCitation: Fonarow GC, van Hout B, Villa G, Arellano J, Lindgren P. Updated Cost-effectiveness Analysis of Evolocumab in Patients With Very High-risk Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2019 Jul 1;4(7):691-695. doi: 10.1001/jamacardio.2019.1647.

ReferenceCitation: Schludi B, Giugliano RP, Sabatine MS, Raal FJ, Teramoto T, Koren MJ, Stein EA, Wang H, Monsalvo ML. Time-averaged low-density lipoprotein cholesterol lowering with evolocumab: Pooled analysis of phase 2 trials. J Clin Lipidol. 2022 Jul-Aug;16(4):538-543. doi: 10.1016/j.jacl.2022.05.069. Epub 2022 Jun 6.

ReferenceCitation: Fagundes A Jr, Morrow DA, Oyama K, Furtado RHM, Zelniker TA, Tang M, Kuder JF, Murphy SA, Hamer A, Keech AC, Sever P, Giugliano RP, Sabatine MS, Bergmark BA. Biomarker Prediction of Complex Coronary Revascularization Procedures in the FOURIER Trial. J Am Coll Cardiol. 2022 Aug 30;80(9):887-897. doi: 10.1016/j.jacc.2022.05.051.

ReferenceCitation: Furtado RHM, Fagundes AA Jr, Oyama K, Zelniker TA, Tang M, Kuder JF, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab in Patients With Prior Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2022 Mar;15(3):e011382. doi: 10.1161/CIRCINTERVENTIONS.121.011382. Epub 2022 Feb 25.

ReferenceCitation: Oyama K, Giugliano RP, Tang M, Bonaca MP, Saver JL, Murphy SA, Ruzza A, Keech AC, Sever PS, Sabatine MS, Bergmark BA. Effect of evolocumab on acute arterial events across all vascular territories : results from the FOURIER trial. Eur Heart J. 2021 Dec 14;42(47):4821-4829. doi: 10.1093/eurheartj/ehab604.

ReferenceCitation: Keech AC, Oyama K, Sever PS, Tang M, Murphy SA, Hirayama A, Lu C, Tay L, Deedwania PC, Siu CW, Lira Pineda A, Choi D, Charng MJ, Amerena J, Wan Ahmad WA, Chopra VK, Pedersen TR, Giugliano RP, Sabatine MS; FOURIER Study Group. Efficacy and Safety of Long-Term Evolocumab Use Among Asian Subjects - A Subgroup Analysis of the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) Trial. Circ J. 2021 Oct 25;85(11):2063-2070. doi: 10.1253/circj.CJ-20-1051. Epub 2021 May 15.

ReferenceCitation: Oyama K, Furtado RHM, Fagundes A Jr, Zelniker TA, Tang M, Kuder J, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization. J Am Coll Cardiol. 2021 Jan 26;77(3):259-267. doi: 10.1016/j.jacc.2020.11.011. Epub 2020 Nov 13.

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

ReferenceCitation: Deedwania P, Murphy SA, Scheen A, Badariene J, Pineda AL, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS, Giugliano RP. Efficacy and Safety of PCSK9 Inhibition With Evolocumab in Reducing Cardiovascular Events in Patients With Metabolic Syndrome Receiving Statin Therapy: Secondary Analysis From the FOURIER Randomized Clinical Trial. JAMA Cardiol. 2021 Feb 1;6(2):139-147. doi: 10.1001/jamacardio.2020.3151.

ReferenceCitation: Gencer B, Mach F, Murphy SA, De Ferrari GM, Huber K, Lewis BS, Ferreira J, Kurtz CE, Wang H, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS, Giugliano RP. Efficacy of Evolocumab on Cardiovascular Outcomes in Patients With Recent Myocardial Infarction: A Prespecified Secondary Analysis From the FOURIER Trial. JAMA Cardiol. 2020 Aug 1;5(8):952-957. doi: 10.1001/jamacardio.2020.0882. Erratum in: JAMA Cardiol. 2021 Aug 1;6(8):980.

ReferenceCitation: Bergmark BA, O'Donoghue ML, Murphy SA, Kuder JF, Ezhov MV, Ceška R, Gouni-Berthold I, Jensen HK, Tokgozoglu SL, Mach F, Huber K, Gaciong Z, Lewis BS, Schiele F, Jukema JW, Pedersen TR, Giugliano RP, Sabatine MS. An Exploratory Analysis of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition and Aortic Stenosis in the FOURIER Trial. JAMA Cardiol. 2020 Jun 1;5(6):709-713. doi: 10.1001/jamacardio.2020.0728.

ReferenceCitation: Wiviott SD, Giugliano RP, Morrow DA, De Ferrari GM, Lewis BS, Huber K, Kuder JF, Murphy SA, Forni DM, Kurtz CE, Honarpour N, Keech AC, Sever PS, Pedersen TR, Sabatine MS. Effect of Evolocumab on Type and Size of Subsequent Myocardial Infarction: A Prespecified Analysis of the FOURIER Randomized Clinical Trial. JAMA Cardiol. 2020 Jul 1;5(7):787-793. doi: 10.1001/jamacardio.2020.0764.

ReferenceCitation: Giugliano RP, Pedersen TR, Saver JL, Sever PS, Keech AC, Bohula EA, Murphy SA, Wasserman SM, Honarpour N, Wang H, Lira Pineda A, Sabatine MS; FOURIER Investigators. Stroke Prevention With the PCSK9 (Proprotein Convertase Subtilisin-Kexin Type 9) Inhibitor Evolocumab Added to Statin in High-Risk Patients With Stable Atherosclerosis. Stroke. 2020 May;51(5):1546-1554. doi: 10.1161/STROKEAHA.119.027759. Epub 2020 Apr 21.

ReferenceCitation: Charytan DM, Sabatine MS, Pedersen TR, Im K, Park JG, Pineda AL, Wasserman SM, Deedwania P, Olsson AG, Sever PS, Keech AC, Giugliano RP; FOURIER Steering Committee and Investigators. Efficacy and Safety of Evolocumab in Chronic Kidney Disease in the FOURIER Trial. J Am Coll Cardiol. 2019 Jun 18;73(23):2961-2970. doi: 10.1016/j.jacc.2019.03.513. Erratum in: J Am Coll Cardiol. 2019 Aug 27;74(8):1162-1166.

ReferenceCitation: Murphy SA, Pedersen TR, Gaciong ZA, Ceska R, Ezhov MV, Connolly DL, Jukema JW, Toth K, Tikkanen MJ, Im K, Wiviott SD, Kurtz CE, Honarpour N, Giugliano RP, Keech AC, Sever PS, Sabatine MS. Effect of the PCSK9 Inhibitor Evolocumab on Total Cardiovascular Events in Patients With Cardiovascular Disease: A Prespecified Analysis From the FOURIER Trial. JAMA Cardiol. 2019 Jul 1;4(7):613-619. doi: 10.1001/jamacardio.2019.0886.

ReferenceCitation: O'Donoghue ML, Fazio S, Giugliano RP, Stroes ESG, Kanevsky E, Gouni-Berthold I, Im K, Lira Pineda A, Wasserman SM, Češka R, Ezhov MV, Jukema JW, Jensen HK, Tokgözoğlu SL, Mach F, Huber K, Sever PS, Keech AC, Pedersen TR, Sabatine MS. Lipoprotein(a), PCSK9 Inhibition, and Cardiovascular Risk. Circulation. 2019 Mar 19;139(12):1483-1492. doi: 10.1161/CIRCULATIONAHA.118.037184.

ReferenceCitation: Qamar A, Giugliano RP, Keech AC, Kuder JF, Murphy SA, Kurtz CE, Wasserman SM, Sever PS, Pedersen TR, Sabatine MS. Interindividual Variation in Low-Density Lipoprotein Cholesterol Level Reduction With Evolocumab: An Analysis of FOURIER Trial Data. JAMA Cardiol. 2019 Jan 1;4(1):59-63. doi: 10.1001/jamacardio.2018.4178.

ReferenceCitation: Martin SS, Giugliano RP, Murphy SA, Wasserman SM, Stein EA, Ceška R, López-Miranda J, Georgiev B, Lorenzatti AJ, Tikkanen MJ, Sever PS, Keech AC, Pedersen TR, Sabatine MS. Comparison of Low-Density Lipoprotein Cholesterol Assessment by Martin/Hopkins Estimation, Friedewald Estimation, and Preparative Ultracentrifugation: Insights From the FOURIER Trial. JAMA Cardiol. 2018 Aug 1;3(8):749-753. doi: 10.1001/jamacardio.2018.1533.

ReferenceCitation: Sabatine MS, De Ferrari GM, Giugliano RP, Huber K, Lewis BS, Ferreira J, Kuder JF, Murphy SA, Wiviott SD, Kurtz CE, Honarpour N, Keech AC, Sever PS, Pedersen TR. Clinical Benefit of Evolocumab by Severity and Extent of Coronary Artery Disease: Analysis From FOURIER. Circulation. 2018 Aug 21;138(8):756-766. doi: 10.1161/CIRCULATIONAHA.118.034309.

ReferenceCitation: Bohula EA, Giugliano RP, Leiter LA, Verma S, Park JG, Sever PS, Lira Pineda A, Honarpour N, Wang H, Murphy SA, Keech A, Pedersen TR, Sabatine MS. Inflammatory and Cholesterol Risk in the FOURIER Trial. Circulation. 2018 Jul 10;138(2):131-140. doi: 10.1161/CIRCULATIONAHA.118.034032. Epub 2018 Mar 12.

ReferenceCitation: Bonaca MP, Nault P, Giugliano RP, Keech AC, Pineda AL, Kanevsky E, Kuder J, Murphy SA, Jukema JW, Lewis BS, Tokgozoglu L, Somaratne R, Sever PS, Pedersen TR, Sabatine MS. Low-Density Lipoprotein Cholesterol Lowering With Evolocumab and Outcomes in Patients With Peripheral Artery Disease: Insights From the FOURIER Trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk). Circulation. 2018 Jan 23;137(4):338-350. doi: 10.1161/CIRCULATIONAHA.117.032235. Epub 2017 Nov 13.

ReferenceCitation: Sabatine MS, Leiter LA, Wiviott SD, Giugliano RP, Deedwania P, De Ferrari GM, Murphy SA, Kuder JF, Gouni-Berthold I, Lewis BS, Handelsman Y, Pineda AL, Honarpour N, Keech AC, Sever PS, Pedersen TR. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Dec;5(12):941-950. doi: 10.1016/S2213-8587(17)30313-3. Epub 2017 Sep 15.

ReferenceCitation: Giugliano RP, Pedersen TR, Park JG, De Ferrari GM, Gaciong ZA, Ceska R, Toth K, Gouni-Berthold I, Lopez-Miranda J, Schiele F, Mach F, Ott BR, Kanevsky E, Pineda AL, Somaratne R, Wasserman SM, Keech AC, Sever PS, Sabatine MS; FOURIER Investigators. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial. Lancet. 2017 Oct 28;390(10106):1962-1971. doi: 10.1016/S0140-6736(17)32290-0. Epub 2017 Aug 28.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Iceland
Japan
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
Estonia
Latvia
Finland
New Zealand
Korea, Republic of
France
Chile
Colombia
Netherlands


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission

acronym: QUAZAR AML-001

summary:
This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy.

The study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the investigator, to continue receiving oral azacitidine after unblinding by sponsor until the participant meets the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the follow-up phase will be followed for survival in the EP.

ReferenceCitation: Roboz GJ, Montesinos P, Selleslag D, Wei A, Jang JH, Falantes J, Voso MT, Sayar H, Porkka K, Marlton P, Almeida A, Mohan S, Ravandi F, Garcia-Manero G, Skikne B, Kantarjian H. Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia. Future Oncol. 2016 Feb;12(3):293-302. doi: 10.2217/fon.15.326. Epub 2016 Jan 19.

ReferenceCitation: Döhner H, Wei AH, Roboz GJ, Montesinos P, Thol FR, Ravandi F, Dombret H, Porkka K, Sandhu I, Skikne B, See WL, Ugidos M, Risueño A, Chan ET, Thakurta A, Beach CL, Lopes de Menezes D. Prognostic impact of NPM1 and FLT3 mutations in patients with AML in first remission treated with oral azacitidine. Blood. 2022 Oct 13;140(15):1674-1685. doi: 10.1182/blood.2022016293.

ReferenceCitation: Zhu J, Wu Q, Wang J, Niu T. Cost-effectiveness analysis of azacitidine maintenance therapy in patients with acute myeloid leukemia. Expert Rev Hematol. 2022 Apr;15(4):375-382. doi: 10.1080/17474086.2022.2061456. Epub 2022 May 11.

ReferenceCitation: Roboz GJ, Ravandi F, Wei AH, Dombret H, Thol F, Voso MT, Schuh AC, Porkka K, La Torre I, Skikne B, Zhong J, Beach CL, Risueño A, Menezes DL, Ossenkoppele G, Döhner H. Oral azacitidine prolongs survival of patients with AML in remission independently of measurable residual disease status. Blood. 2022 Apr 7;139(14):2145-2155. doi: 10.1182/blood.2021013404.

ReferenceCitation: Ravandi F, Roboz GJ, Wei AH, Döhner H, Pocock C, Selleslag D, Montesinos P, Sayar H, Musso M, Figuera-Alvarez A, Safah H, Tse W, Sohn SK, Hiwase D, Chevassut T, Pierdomenico F, La Torre I, Skikne B, Bailey R, Zhong J, Beach CL, Dombret H. Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial. J Hematol Oncol. 2021 Aug 28;14(1):133. doi: 10.1186/s13045-021-01142-x.

ReferenceCitation: Wei AH, Döhner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, Ravandi F, Sayar H, Jang JH, Porkka K, Selleslag D, Sandhu I, Turgut M, Giai V, Ofran Y, Kizil Çakar M, Botelho de Sousa A, Rybka J, Frairia C, Borin L, Beltrami G, Čermák J, Ossenkoppele GJ, La Torre I, Skikne B, Kumar K, Dong Q, Beach CL, Roboz GJ; QUAZAR AML-001 Trial Investigators. Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission. N Engl J Med. 2020 Dec 24;383(26):2526-2537. doi: 10.1056/NEJMoa2004444.

lead_sponsor: Celgene

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Mexico
Brazil
Canada
Germany
Taiwan
Ireland
Finland
Korea, Republic of
France

location_facility: Nizhniy Novgorod State Medical Academy of Roszdrav

location_facility: Washington University School of Medicine

location_facility: Center Hospitalier Universitaire Ambroise Pare

location_facility: Northwestern University Medical Center Division of Hematology Oncology

location_facility: Centro Hospital e Universitario de Coimbra

location_facility: Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira

location_facility: George Washington University Cancer Center

location_facility: University of California San Francisco Fresno Campus

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Kansas City VA Medical Center University of Kansas Medical Center

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Cancer Care Centers of South Texas - Loop

location_facility: Institute of Internal Diseases University of Medicine

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

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

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: University Hospitals Case Medical Center

location_facility: Hospital Angeles Lomas - Consultorio 830

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centre hospitalier de Boulognes - Duchenne

location_facility: Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce

location_facility: ASST Grande Ospedale Metropolitano Niguarda, Milano

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord AORMN

location_facility: Norton Cancer Institute Louisville Oncology

location_facility: Fondazione Ca Granda IRCCS Ospedale Maggiore

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Centre Hospitalier de Versailles Hopital Andre Mignot

location_facility: Regional Health Authority B-Saint John Regional Hospital

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

location_facility: Az. Osp. SS.Antonio e Biagio - SC Ematologia

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Wilhelm-Anton-Hospital Goch gGmbH Hämatologie und Internistische Onkologie

location_facility: Flinders Medical Centre, Dept Of Oncology

location_facility: SLK Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen

location_facility: Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL

location_facility: Saint Petersburg Medical State Institution Municipal n.a. I.P. Pavlov

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji hospital

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

location_facility: VA Commonwealth University Massey Cancer Center

location_facility: Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust

location_facility: Casa di Cura La Maddalena, Divisione di Ematologia

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Ondokuz Mayis University Medical Faculty

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Kaiser Permanente Northwest Oncology Hematology

location_facility: Yakima Valley Memorial Hospital/ North Star Lodge

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Mater Private Medical Centre Haematology and Oncology Clinics of Australasia Research Centre

location_facility: Azienda ospedeliera della 2 Universita di Napoli

location_facility: University of Florida Health Cancer Center at Orlando Health

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

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Biziela

location_facility: Froedtert Hospital BMT Medical College of Wisconsin

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: McGill University, Dept. Oncology Clinical Research Program

location_facility: IRCCS AziendaOspedaliera Universitaria San Martino

location_facility: Staedtisches Klinikum Muenchen Schwabing

location_facility: University HospitaClinik of internal medicin

location_facility: Azienda Ospedaliera S. Andrea - Università La Sapienza

location_facility: Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin

location_facility: Institute of Hematology and Transfusion Medicine

location_facility: Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos

location_facility: Staedtische Kliniken Frankfurt am Main Hochst

location_facility: Instituto Portugues de Oncologia do Porto, Francisco Gentil

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

location_facility: Providence St Joseph Medical Center Cancer Center

location_facility: Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I

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

location_facility: University of Texas Southwestern Medical Center

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: University of Southern California Norris Cancer Center


title: A Prospective, Randomized, Open Label, Two Arm Phase III Study to Evaluate Treatment Free Remission (TFR) Rate in Patients With Philadelphia-positive CML After Two Different Durations of Consolidation Treatment With Nilotinib 300mg BID.

acronym: ENESTPath

summary: This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained in treatment-free remission (≥MR4.0) without molecular relapse 12 months after starting the Treatment-Free Remission (TFR) phase.

ReferenceCitation: Borghi L, Rosti G, Maggi A, Breccia M, Di Bona E, Iurlo A, La Barba G, Sportoletti P, Albano F, Galimberti S, Rivellini F, Cambrin GR, Capodanno I, Cuneo A, Bonifacio M, Sica S, Arcaini L, Capochiani E, Minotto C, Ciceri F, Crugnola M, Di Caprio L, Supekar S, Elena C, Baccarani M, Vegni E. Perspectives and Emotional Experiences of Patients With Chronic Myeloid Leukemia During ENESTPath Clinical Trial and Treatment-Free Remission: Rationale and Protocol of the Italian Substudy. Front Oncol. 2021 May 26;11:638689. doi: 10.3389/fonc.2021.638689. eCollection 2021.

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

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

location_country:
Serbia
Spain
Italy
United Kingdom
Romania
Belgium
Czechia
Poland
Portugal
Slovenia
Austria
Norway
Sweden
Slovakia
Hungary
Germany
Bulgaria
Denmark
Greece
Finland
France


title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

acronym: OPTIMISMM

summary: The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.

ReferenceCitation: Richardson PG, Oriol A, Beksac M, Liberati AM, Galli M, Schjesvold F, Lindsay J, Weisel K, White D, Facon T, San Miguel J, Sunami K, O'Gorman P, Sonneveld P, Robak P, Semochkin S, Schey S, Yu X, Doerr T, Bensmaine A, Biyukov T, Peluso T, Zaki M, Anderson K, Dimopoulos M; OPTIMISMM trial investigators. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):781-794. doi: 10.1016/S1470-2045(19)30152-4. Epub 2019 May 13.

ReferenceCitation: Richardson PG, Hofmeister CC, Raje NS, Siegel DS, Lonial S, Laubach J, Efebera YA, Vesole DH, Nooka AK, Rosenblatt J, Doss D, Zaki MH, Bensmaine A, Herring J, Li Y, Watkins L, Chen MS, Anderson KC. Pomalidomide, bortezomib and low-dose dexamethasone in lenalidomide-refractory and proteasome inhibitor-exposed myeloma. Leukemia. 2017 Dec;31(12):2695-2701. doi: 10.1038/leu.2017.173. Epub 2017 Jun 2. Erratum in: Leukemia. 2018 Oct;32(10):2305.

location_country:
Spain
Italy
United Kingdom
United States
Japan
Poland
Portugal
Austria
Russian Federation
Puerto Rico
Israel
Turkey
Norway
Sweden
Canada
Germany
Denmark
Greece
Ireland
Finland
France
Netherlands

location_facility: Gazi Universitesi Tip Fakultesi Hastanesi

location_facility: Wilhelminenspital-Center for Hematology and Oncology

location_facility: University of California San Francisco Fresno Campus

location_facility: Klinika Hematoonkologii i Transplantacji Szpiku

location_facility: Kansas City VA Medical Center University of Kansas Medical Center

location_facility: Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine

location_facility: Alves Domenech Oncology and Hematology Clinic

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: Centre De Sante Et De Services Sociaux De Rimouski-Neigette

location_facility: Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego

location_facility: USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII

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

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: Universitaetsklinikum EssenInnere Klinik und Poliklinik

location_facility: Brooke Army Medical Center Francis Street Medical Center

location_facility: Klinika Hematologii Akademii Medycznej w Gdansku

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: St. John's Clinic Cancerand Hematology - Springfield

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Copenhagen University Hospital Rigshosptalet

location_facility: RSM Durham Regional Cancer Center - Lakeridge Health Oshawa

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital

location_facility: Joe Arrington Cancer Research and Treatment Center

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

location_facility: Hematology-Oncology Associates of NNJ, P

location_facility: Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont

location_facility: Complejo Hospitalario Nuestra Senora de Valme

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Biziela

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit

location_facility: University Hospital of North Staffordshire Nhs Trust - City General Hospital

location_facility: Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole

location_facility: Western Kentucky Hematology and Oncology Group, PSC

location_facility: George Papanikolaou General Hospital of Thessaloniki

location_facility: Worcestershire Acute Hospitals NHS Trust

location_facility: University of Tennessee Medical Center - Cancer Institute

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

location_facility: Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara

location_facility: State Budgetary Healthcare Institution of Nizhniy Novgorod Region

location_facility: A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC

location_facility: Azienda Ospedaliera San Giovanni Battista

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Henry Ford Medical Center - New Center One

location_facility: University of Athens Medical school - Regional General Hospital

location_facility: Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute

location_facility: Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie


primary_purpose: Prevention

acronym: EUCLID

title: A Randomized, Double-blind, Parallel Group, Multicentre Phase IIIb Study to Compare Ticagrelor With Clopidogrel Treatment on the Risk of Cardiovascular Death, Myocardial Infarction and Ischemic Stroke in Patients With Established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)

lead_sponsor: AstraZeneca

ReferenceCitation: Szarek M, Hess C, Patel MR, Jones WS, Berger JS, Baumgartner I, Katona B, Mahaffey KW, Norgren L, Blomster J, Rockhold FW, Hsia J, Fowkes FGR, Bonaca MP. Total Cardiovascular and Limb Events and the Impact of Polyvascular Disease in Chronic Symptomatic Peripheral Artery Disease. J Am Heart Assoc. 2022 Jun 7;11(11):e025504. doi: 10.1161/JAHA.122.025504. Epub 2022 May 27.

ReferenceCitation: Govsyeyev N, Nehler MR, Low Wang CC, Kavanagh S, Hiatt WR, Long C, Jones WS, Fowkes FGR, Berger JS, Baumgartner I, Patel MR, Goodney PP, Beckman JA, Katona BG, Mahaffey KW, Blomster J, Norgren L, Bonaca MP. Etiology and outcomes of amputation in patients with peripheral artery disease in the EUCLID trial. J Vasc Surg. 2022 Feb;75(2):660-670.e3. doi: 10.1016/j.jvs.2021.08.096. Epub 2021 Sep 28.

ReferenceCitation: Norgren L, North R, Baumgartner I, Berger JS, Blomster JI, Hiatt WR, Jones WS, Katona BG, Mahaffey KW, Mulder H, Patel MR, Rockhold FW, Fowkes FGR. World regional differences in outcomes for patients with peripheral artery disease: Insights from the EUCLID trial. Vasc Med. 2022 Feb;27(1):21-29. doi: 10.1177/1358863X211038620. Epub 2021 Sep 13.

ReferenceCitation: Hiatt WR, Hess CN, Bonaca MP, Kavanagh S, Patel MR, Baumgartner I, Berger JS, Blomster JI, Jones WS, Katona BG, Mahaffey KW, Norgren L, Rockhold FW, Fowkes FGR. Ankle-Brachial Index for Risk Stratification in Patients With Symptomatic Peripheral Artery Disease With and Without Prior Lower Extremity Revascularization: Observations From the EUCLID Trial. Circ Cardiovasc Interv. 2021 Jul;14(7):e009871. doi: 10.1161/CIRCINTERVENTIONS.120.009871. Epub 2021 Jul 13.

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location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Philippines
Japan
Czechia
Poland
Russian Federation
Argentina
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Thailand
Vietnam
Korea, Republic of
France
Chile
Netherlands

summary: The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.


title: A Randomized, Multicenter, Multicountry Study to Evaluate the Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and to Evaluate the Relationship Between Florbetapir (18F) PET Scan Status and Cognitive Decline

summary: This study is designed to determine the effectiveness of florbetapir (18F) in changing patient management and to evaluate the association between scan status and cognitive decline.

primary_purpose: Diagnostic

lead_sponsor: Avid Radiopharmaceuticals

location_country:
United States
Italy
France