acronym: SafeHER

title: A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer

design_allocation: Non-Randomized

ReferenceCitation: Jung KH, Ataseven B, Verrill M, Pivot X, De Laurentiis M, Al-Sakaff N, Lauer S, Shing M, Gligorov J, Azim HA. Adjuvant Subcutaneous Trastuzumab for HER2-Positive Early Breast Cancer: Subgroup Analyses of Safety and Active Medical Conditions by Body Weight in the SafeHer Phase III Study. Oncologist. 2018 Oct;23(10):1137-1143. doi: 10.1634/theoncologist.2018-0065. Epub 2018 Jul 17.

ReferenceCitation: Gligorov J, Ataseven B, Verrill M, De Laurentiis M, Jung KH, Azim HA, Al-Sakaff N, Lauer S, Shing M, Pivot X; SafeHer Study Group. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients. Eur J Cancer. 2017 Sep;82:237-246. doi: 10.1016/j.ejca.2017.05.010. Epub 2017 Jun 16.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Croatia
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
Lithuania
Ukraine
Venezuela
El Salvador
Peru
Romania
Philippines
South Africa
Czechia
Poland
Albania
Hong Kong
Portugal
Slovenia
Russian Federation
Australia
Argentina
Indonesia
Uruguay
Turkey
Panama
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Egypt
Bosnia and Herzegovina
Brazil
Canada
Switzerland
Guatemala
Hungary
Germany
Bulgaria
Taiwan
Dominican Republic
Greece
Ireland
New Zealand
Ecuador
Thailand
Vietnam
Algeria
France
Chile
Korea, Republic of
Colombia
Netherlands
Morocco
Pakistan
United Arab Emirates

location_facility: Istanbul Uni of Medicine Faculty; Oncology Dept

location_facility: Oncology Unit, Faculty of Medicine, Vajira Hospital; Department of Medicine

location_facility: Emergency University Bucharest Hospital; Oncology Department

location_facility: Klinikum Leverkusen; Med. Klinik III / Onkologie

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: Philippine General Hospital; Section Of Medical Oncology

location_facility: Royal Perth Hospital; Department of Medical Oncology

location_facility: Royal Shrewsbury Hospital; Pharmacy Department

location_facility: Tri-Service General Hospital, Division of General Surgery

location_facility: ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

location_facility: Hospital de Sao Joao; Servico de Oncologia

location_facility: Ospedale Garibaldi Nesima; Biomedicina Clinica e Molecolare

location_facility: Marmara Uni Faculty of Medicine; Medical Oncology

location_facility: University Hospital of Larissa; Oncology

location_facility: Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe

location_facility: Glan Clwyd Distr Gen Hospital;Nth Wales Cancer Treatment Ctr

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

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

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: National Cancer Centre; Medical Oncology

location_facility: Centre Antoine Lacassagne; B3 Medecine Conventionnelle

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Fakultna nemocnica s poliklinikou J.A. Reimana Presov

location_facility: Fakultna nemocnica Trencín; Onkologicke odd.

location_facility: Beaumont Hospital; Cancer Clinical Trials Unit

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

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Poradnia Onkologiczna oraz Oddzial Kliniczny Onkologii SPZOZ Szpital Uniwersytecki

location_facility: Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer

location_facility: King Faisal Specialist Hospital & Research Centre

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: 19 Mayis University Medical Faculty; Medical Oncology Department

location_facility: Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: Hospital Lluis Alcanys; Servicio de Oncologia

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

location_facility: Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Hasan Sadikin Hospital; Internal Medicine

location_facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: IFO - Istituto Regina Elena; Oncologia Medica

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum

location_facility: Klinikum Ludwigsburg; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Maasstad ziekenhuis; Afdeling oncologie hematologie

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde

location_facility: Masarykův onkologický ústav; Klinika komplexní onkologické péče

location_facility: Clinical Hospital Osijek; Dept For Oncology & Radiotherapy

location_facility: Ch Lyon Sud; Onco Secteur Jules Courmont

location_facility: Periph. University General Hospital of Heraklion Crete; Oncology Department

location_facility: Pramongkutklao Hospital; Medicine - Medical Oncology Unit

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia

location_facility: Centre Georges-François Lecler; Ctr de Lutte Contre le Canc

location_facility: Skaraborgs sjukhus Skoevde, Dept of surgery

location_facility: Catharina Ziekenhuis; Dept of Internal Medicin

location_facility: Ausl Frosinone - Ospedale Umberto I; Divisione Di Oncologia

location_facility: University "Mother Theresa" Hospital Center; Oncology Department

location_facility: Hospital Carlos Van Buren, Servicio de Oncologia

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: National Cancer Institute - Comenius University; Dept. Clinical Oncology

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Kyiv City Clinical Oncological Center; Chemotherapy Department

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori; S. C. Oncologia Medica 2

location_facility: Ankara Uni School of Medicine; Medical Oncology

location_facility: Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

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

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Praxis Dr. Prechtl & Dr. Kowolik; Frauenklinik

location_facility: Martini Ziekenhuis; Dept of Internal Medicine

location_facility: Policlinica Sfanta Maria - Oncology; Medical Oncology

location_facility: Kantonsspital Frauenfeld, Frauenklinik Thurgau

location_facility: Hopitaux Du Leman Site Thonon; Maternite Gynecologie

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: University Hospital Birmingham Queen Elizabeth Hospital

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Caritas Klinik St. Theresia -Frauenklinik Brustzentrum

location_facility: Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia

location_facility: Shaukat Khanum Memorial Cancer Hospital; Department of Oncology

location_facility: Maxima Medisch Centrum; Inwendige Geneeskunde

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

location_facility: Instituto De Investigaciones Clinicas Zarate

location_facility: Princess Alexandra Hospital; Oncology Department

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: Ospedale Vito Fazzi; Div. Oncoematologia

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: CMCO De La Cote D Opale; Auberge De Jour

location_facility: Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia

location_facility: Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe

location_facility: Atrium Medisch Centrum Parkstad, Heerlen

location_facility: Internist; Praxis Für Haemotologie & Onkologie

location_facility: Laiko General Hospital; 1St Pathological Clinic

location_facility: University Medical Centre Maribor; Depart. of Gynecology & Breast Oncology

location_facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Kantonsspital Winterthur; Medizinische Onkologie

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: Institut National D'oncologie Sidi Med Benabdellah

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

location_facility: Waterford Regional Hospital; Department Of Medical Oncology

location_facility: Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: Rijnstate Ziekenhuis; Inwendige Geneeskunde

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: China Medical University Hospital; Surgery

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

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

location_facility: Clinical Hospital Center Bezanijska kosa; Clinic for Oncology

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Clinical Centre Nis, Clinic for Oncology

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología

location_facility: Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3

location_facility: CiptoMangunkusumo Hospital; Internal Medicine

location_facility: Hospital de Cabueñes; Servicio de Oncologia

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: NZOZ Onko-Dent SP. P. G. L. Slomian, Poradnia Onkologiczna

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Josa Andras Korhaz; Dept of Oncoradiology

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Centro Estatal de Cancerologia de Nayarit

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

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: DONAU ISAR Klinikum Deggendorf; Frauenklinik

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

location_facility: Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

location_facility: Clinical Hospital 1 Craiova; Medical Oncology

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

location_facility: Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: King Abdul Aziz Medical City, King Fahd National Guard; Oncology

location_facility: Princess Alexandra Hospital; Division of Cancer Services

location_facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

location_facility: Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Sardjito Hospital; Instalasi Kanker Tulip

location_facility: Centro Médico Docente La Trinidad; Unidad de Protocolos Clínicos

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Lahn-Dill Kliniken GmbH Klinikum Wetzlar Gynäkologie/Geburtshilfe

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: National Cheng Kung Uni Hospital; Surgery

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: University Clinical Center of the Republic of Srpska

location_facility: IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

location_facility: Hospital General de Elda; Servicio de Oncologia

location_facility: Spaarne Ziekenhuis; Inwendige Geneeskunde

location_facility: Albert Schweitzer Ziekenhuis - loc Dordrecht

location_facility: medius KLINIK OSTFILDERN-RUIT; Brustzentrum

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

location_facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

location_facility: Ospedale Civile SS Annunziata; oncologia medica

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Hospital Do Meixoeiro; Servicio de Oncologia

location_facility: Forth Valley Royal Hospital ; Oncology Department

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: Heartlands Hospital; Department Of Medicine

location_facility: Ospedale Oncologico A.Businco; Div. Oncologia Medica II

location_facility: Hospital Pulau Pinang; Jabatan Radioterapi & Onkologi

location_facility: Shifa International Hospital; Department of Oncology

location_facility: Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Instituto de Cáncer SOLCA Cuenca; Oncología

location_facility: Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: S.C. Life Search S.R.L; Medical Oncology Clinic

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: Katholische Hospitalvereinigung Ostwestfalen gGmbH

location_facility: Queen Elizabeth Hospital; Medical Oncology

location_facility: Klinikum St. Georg GmbH; Franziskus-Hospital Harderberg; Klinik für Gynaekologie und Geburtshilfe

location_facility: University Malaya Medical Centre; Clinical Oncology Unit,

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel

location_facility: Cluj Clinical County Hospital; Oncology Dept

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Institut de Cancerologie de La Loire; Pneumologie

location_facility: MHAT Serdika; Department of medical oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: ASKLEPIOS KREISKRANKENHÄUSER WEIßENFELS-HOHENMÖLSEN GMBH

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Department of Surgery, King Chulalongkorn Memorial Hospital

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

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

location_facility: Uni Hospital of Alexandroupoli; Dept. of Oncology - Duth

location_facility: Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin

location_facility: Azienda USL di Ravenna; Unità Operativa di Oncologia Medica

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

location_facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

location_facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: Hameed Latif Hospital; Department of Oncology

location_facility: Derriford Hospital; Plymouth Oncology Centre

location_facility: The Royal Wolverhampton Hospitals NHS Trust

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Hospital Pereira Rossell; Oncology Department

location_facility: Centre Azureen De Cancerologie; Cons externes

location_facility: Solca Guayaquil- Sociedad de Lucha Contra El Cáncer; Oncology

location_facility: Royal Hampshire County Hospital; Winchester & Andover Breast Unit

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Vlietland Ziekenhuis, Locatie Schiedam; Interne Geneeskunde

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: City Clinical Oncology Dispensary, SPb SBIH CCOD

location_facility: Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde

location_facility: IRRCCS San Matteo; Dip Oncoematologico ; Divisione Oncologia

location_facility: Gesellschaft für Medizinische Studien Würselen

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: Hospital de Basurto; Servicio de Oncologia

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

location_facility: Aga Khan University; Department of Oncology

location_facility: Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Ch Francois Mitterrand; Medecine Oncologie

location_facility: Clinique Radio Des Dentellieres; Chimiotherapie Radiotherapie

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Centro Clinico Champalimaud; Oncologia Medica

summary: This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).


type: EudraCT Number

type: Other Identifier

title: Adjuvant Systemic Treatment for Oestrogen-receptor (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment. A French UNICANCER Geriatric Oncology Group (GERICO) and Breast Group (UCBG) Multicentre Phase III Trial

acronym: ASTER 70s

summary: The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: UNICANCER

location_country: France Belgium

location_facility: Centre d'oncologie et de radiothérapie du Parc

location_facility: Centre Hospitalier Intercommunal de Meulan - Les Mureaux

location_facility: Groupe Hospitalier des Diaconesses - Croix Saint Simon

location_facility: Cliniques universitaires Saint-Luc - UCL

location_facility: Groupement Hospitalier Public du Sud de l'Oise - site de Creil

location_facility: Institut Curie - Hôpital Claudius Regaud

location_facility: RISSA Sarcelles (GCS Recherche & Innovation Santé Sarcelles)

location_facility: Centre Hôspitalier de Wallonie Picarde (CHWAPI)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Global Multi-centre Observational Study in RA Patients Who Are Non Responders or Intolerant to a Single TNF Inhibitor.

summary: This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

lead_sponsor: Hoffmann-La Roche

location_country:
Portugal
Spain
Greece
Italy
Mexico
United Kingdom
Canada
Monaco
France
Colombia
Norway
Germany

status_simplified: Completed


title: A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)

acronym: STOP-HCC

summary: The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.

ReferenceType: derived

ReferenceCitation: Chauhan N, Bukovcan J, Boucher E, Cosgrove D, Edeline J, Hamilton B, Kulik L, Master F, Salem R. Intra-Arterial TheraSphere Yttrium-90 Glass Microspheres in the Treatment of Patients With Unresectable Hepatocellular Carcinoma: Protocol for the STOP-HCC Phase 3 Randomized Controlled Trial. JMIR Res Protoc. 2018 Aug 15;7(8):e11234. doi: 10.2196/11234.

lead_sponsor: Boston Scientific Corporation

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

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Azienda Ospedaliero -Universitaria di Bologna

location_facility: Servicio de Radiología, Hospital Universitario Virgen de la Arrixaca.

location_facility: University College London Cancer Institute

location_facility: Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie

location_facility: Universitätsklinikum Leipzig, Klinik für Diagnostische und Interventionelle Radiologie

location_facility: Banner - University Medical Center Phoenix

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: McGill University Health Centre / Royal Victoria Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Seattle Cancer Care Alliance/University of Washington Medical Center

location_facility: Hosptal Universitario Central de Asturias (nuevo HUCA)

location_facility: Hospital Clínico Universitario de Valladolid

intervention_type: Device


title: Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) in Patients With Resected Pancreatic Adenocarcinoma

source: euctr

ReferenceCitation: Conroy T, Castan F, Lopez A, Turpin A, Ben Abdelghani M, Wei AC, Mitry E, Biagi JJ, Evesque L, Artru P, Lecomte T, Assenat E, Bauguion L, Ychou M, Bouché O, Monard L, Lambert A, Hammel P; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer: A Randomized Clinical Trial. JAMA Oncol. 2022 Sep 1. doi: 10.1001/jamaoncol.2022.3829. [Epub ahead of print]

ReferenceCitation: Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Choné L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.

location_country: Canada France

location_facility: McGill University (Department of Oncology)

location_facility: Juravinski Cancer centre at Hamilton Health Sciences

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: The Royal Victoria Hospital - Cancer Care Program

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: General Surgery - TGH Site, Univ. Health Network

location_facility: Fondation Ambroise Paré / Hôpital Européen

location_facility: Department of Medical Oncology Health Sciences North

location_facility: Saskatoon Cancer Centre, University of Saskatchewan

location_facility: CancerCare Manitoba, St. Boniface General Hospital

location_facility: Algoma District Cancer Program, Sault Area Hospital

summary: This is a multicentric randomized phase III trial comparing adjuvant chemotherapy with gemcitabine versus 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFolfirinox) in patients with resected pancreatic adenocarcinoma.


title: Medtronic Product Surveillance Registry

acronym: PSR

summary: The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Qin D, Filippaios A, Murphy J, Berg M, Lampert R, Schloss EJ, Noone M, Mela T. Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry. Circ Arrhythm Electrophysiol. 2022 Aug;15(8):e011029. doi: 10.1161/CIRCEP.122.011029. Epub 2022 Aug 4.

ReferenceCitation: Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.

ReferenceCitation: Singh JP, Cha YM, Lunati M, Chung ES, Li S, Smeets P, O'Donnell D. Real-world behavior of CRT pacing using the AdaptivCRT algorithm on patient outcomes: Effect on mortality and atrial fibrillation incidence. J Cardiovasc Electrophysiol. 2020 Apr;31(4):825-833. doi: 10.1111/jce.14376. Epub 2020 Feb 28.

ReferenceCitation: Stearns LM, Abd-Elsayed A, Perruchoud C, Spencer R, Hammond K, Stromberg K, Weaver T. Intrathecal Drug Delivery Systems for Cancer Pain: An Analysis of a Prospective, Multicenter Product Surveillance Registry. Anesth Analg. 2020 Feb;130(2):289-297. doi: 10.1213/ANE.0000000000004425.

lead_sponsor: Medtronic

location_country:
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
United States
Belgium
Iceland
Japan
South Africa
Czechia
Poland
Hong Kong
Portugal
Slovenia
Russian Federation
Australia
Argentina
Puerto Rico
India
Israel
Mexico
Norway
Malaysia
Sweden
Slovakia
Kuwait
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Greece
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands
United Arab Emirates


title: LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy

summary: This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.

ReferenceCitation: Lu S, Li W, Zhou C, Hu CP, Qin S, Cheng G, Feng J, Wang J, Cseh A, Peil B, Gibson N, Ehrnrooth E, Zhang L. Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung. Onco Targets Ther. 2018 Nov 30;11:8565-8573. doi: 10.2147/OTT.S161506. eCollection 2018.

ReferenceCitation: Goss GD, Felip E, Cobo M, Lu S, Syrigos K, Lee KH, Göker E, Georgoulias V, Li W, Guclu S, Isla D, Min YJ, Morabito A, Ardizzoni A, Gadgeel SM, Fülöp A, Bühnemann C, Gibson N, Krämer N, Solca F, Cseh A, Ehrnrooth E, Soria JC. Association of ERBB Mutations With Clinical Outcomes of Afatinib- or Erlotinib-Treated Patients With Lung Squamous Cell Carcinoma: Secondary Analysis of the LUX-Lung 8 Randomized Clinical Trial. JAMA Oncol. 2018 Sep 1;4(9):1189-1197. doi: 10.1001/jamaoncol.2018.0775.

ReferenceCitation: Gadgeel S, Goss G, Soria JC, Felip E, Georgoulias V, Lu S, Cobo M, Syrigos K, Lee KH, Göker E, Guclu SZ, Isla D, Morabito A, Dupuis N, Bühnemann C, Krämer N, Solca F, Ehrnrooth E, Ardizzoni A. Evaluation of the VeriStrat(®) serum protein test in patients with advanced squamous cell carcinoma of the lung treated with second-line afatinib or erlotinib in the phase III LUX-Lung 8 study. Lung Cancer. 2017 Jul;109:101-108. doi: 10.1016/j.lungcan.2017.05.010. Epub 2017 May 11.

ReferenceCitation: Soria JC, Felip E, Cobo M, Lu S, Syrigos K, Lee KH, Göker E, Georgoulias V, Li W, Isla D, Guclu SZ, Morabito A, Min YJ, Ardizzoni A, Gadgeel SM, Wang B, Chand VK, Goss GD; LUX-Lung 8 Investigators. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015 Aug;16(8):897-907. doi: 10.1016/S1470-2045(15)00006-6. Epub 2015 Jul 5.

lead_sponsor: Boehringer Ingelheim

location_country:
Spain
Italy
United Kingdom
United States
Portugal
Austria
Argentina
India
Turkey
Mexico
Singapore
Canada
Hungary
China
Germany
Denmark
Taiwan
Greece
Ireland
Korea, Republic of
France
Chile
Netherlands

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Washington University School of Medicine

location_facility: Centro Hemato-Oncologico Privado de Toluca S.A. de C.V.

location_facility: METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht

location_facility: Ospedale Molinette, AO Città della Salute e della

location_facility: Uludag Universitesi Tip Fakultesi, Bursa

location_facility: Institute of Chest Diseases Csongrad County,Dpt. Pulmonology

location_facility: B. P .Poddar Hospital & Medical Research Ltd.

location_facility: West Jefferson General Hospital and Cancer Clinic

location_facility: Paris Cancer Center (PCC), Texas Oncology

location_facility: National Koranyi TBC and Pulm. Internal Med. Clinic

location_facility: Maidstone Hospital, Kent Oncology Centre

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Instituto de Terapias Oncologicas Providencia

location_facility: Sri Ramachandra Medical College & Research Institute

location_facility: Pulmonology Institute of Veszprem County, Farkasgyepu

location_facility: Aladar Petz County Teaching Hospital, Dept. Pulmonology

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

location_facility: Gaziantep Univ. Tip Fakultesi Tibbi Onkoloji Bilim Dali

location_facility: Boca Raton Reginl Hospital-Lynn Cancer Institute

location_facility: Johns Hopkins Singapore International Medical Centre

location_facility: P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna

location_facility: Hospital Regional Universitario de Málaga

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: University Hospital of Larisa, Oncology Clinic

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Pest County Lung Hospital, Department No. 3

location_facility: The Ohio State University Wexner Medical Center

location_facility: University of Pecs, 1st internal Med. Dept., Pulmonology

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Koo Foundation Sun Yet-Sen Cancer Center

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: General Hospital of Chest Diseases Sotiria

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Centro Internacional de Estudios Clinicos - CIEC

location_facility: Seoul National University Bundang Hospital

location_facility: Xiangya Hospital, Central South University

location_facility: "Hippokratio" Hospital of Athens, 2nd Internal Medicine Clin

location_facility: Lung Hospital of Matra, Dept. Pulmonology

location_facility: Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali

location_facility: SMZ Baumgartner Hoehe Otto Wagner Spital

location_facility: Cancer Center of Cookeville Regional Medical Center

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

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

location_facility: University General Hospital of Heraklion

location_facility: Oncology Hematology Associates of Norhtern Pennsylvania, PC


title: An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)

summary: Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

time_perspective: Other

ReferenceCitation: Halimi JM, Al-Dakkak I, Anokhina K, Ardissino G, Licht C, Lim WH, Massart A, Schaefer F, Walle JV, Rondeau E. Clinical characteristics and outcomes of a patient population with atypical hemolytic uremic syndrome and malignant hypertension: analysis from the Global aHUS registry. J Nephrol. 2022 Sep 24. doi: 10.1007/s40620-022-01465-z. [Epub ahead of print]

ReferenceCitation: Woodward L, Johnson S, Walle JV, Beck J, Gasteyger C, Licht C, Ariceta G; aHUS Registry SAB. An innovative and collaborative partnership between patients with rare disease and industry-supported registries: the Global aHUS Registry. Orphanet J Rare Dis. 2016 Nov 21;11(1):154. Review.

ReferenceCitation: Licht C, Ardissino G, Ariceta G, Cohen D, Cole JA, Gasteyger C, Greenbaum LA, Johnson S, Ogawa M, Schaefer F, Vande Walle J, Frémeaux-Bacchi V. The global aHUS registry: methodology and initial patient characteristics. BMC Nephrol. 2015 Dec 10;16:207. doi: 10.1186/s12882-015-0195-1.

ReferenceCitation: Belingheri M, Possenti I, Tel F, Paglialonga F, Testa S, Salardi S, Ardissino G. Cryptic activity of atypical hemolytic uremic syndrome and eculizumab treatment. Pediatrics. 2014 Jun;133(6):e1769-71. doi: 10.1542/peds.2013-2921. Epub 2014 May 19.

ReferenceCitation: Ardissino G, Possenti I, Tel F, Testa S, Paglialonga F. Time to change the definition of hemolytic uremic syndrome. Eur J Intern Med. 2014 Feb;25(2):e29. doi: 10.1016/j.ejim.2013.12.002. Epub 2013 Dec 21.

ipd_sharing: No

lead_sponsor: Alexion Pharmaceuticals

location_country:
Denmark
Poland
Taiwan
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Korea, Republic of
United States
France
Israel
Belgium
Germany

location_facility: University of Florida, Division of Nephrology

location_facility: Washington University School of Medicine

location_facility: HEGP - Hopital Europeen Georges Pompidou

location_facility: Emory Children's Center Emory University

location_facility: CHRU de Caen Hopital Clemenceau Service de Nephrologie

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

location_facility: Soon ChunHyang University Hospital Cheonan

location_facility: Pusan National University Yangsan Hospital

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: Hopital Robert Debre Service de Nephrologie Pediatrique

location_facility: China Medical University Hospital (CMUH)

location_facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Klinkzny

location_facility: Centre Hospitialier Regional de Chambery

location_facility: Chang Cung Memorial Hospital - LK (CGMH-LK)

location_facility: Pad Croff Nefrologia Ospedale Maggiore Policlinico

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Le Centre Hospitialier Universitarie de Nice Hopital Pasteur

location_facility: Hopital Necker, Enfants Malades Service de Nephrologie Pediatrique

location_facility: Cliniques Universitaires Saint-Luc (Pediatric)

location_facility: Medizinische Hochschule Hannover Pediatric Nephrology

location_facility: Children's City Clinical Hospital of Saint Vladimir

location_facility: National Taiwan University Hospital (NTUH)

location_facility: CHU de Liege - Clinique de l'Esperance (pediatric)

location_facility: Cliniques Universitaires Saint-Luc (adult)

location_facility: S C Nefrologia - A O Ospedale Niguarda-Ca Granda

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico

location_facility: U O Nefrologia e Dialisi Pediatrica Ospedale Giovanni XXIII

location_facility: Severance Hospital Yonsei University Health System

location_facility: Royal Devon & Exeter NHS Foundation Trust

location_facility: Medizinische Hochschule Hannover Adult Nephrology

location_facility: Veteran's General Hospital - Kaohsiung (VGH-KS)

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Dipartmento di Nefrologia e Urologia Ospedale Pediatrico Bambin Gesu


title: An Observational, Multi-Center, Multi-National, Long Term Follow-Up Study of Atypical Hemolytic Uremic Syndrome (aHUS) Patients Treated With Eculizumab in a Prior Clinical Study

acronym: LTFU

summary: There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.

status: Terminated

ReferenceCitation: Menne J, Delmas Y, Fakhouri F, Licht C, Lommelé Å, Minetti EE, Provôt F, Rondeau E, Sheerin NS, Wang J, Weekers LE, Greenbaum LA. Outcomes in patients with atypical hemolytic uremic syndrome treated with eculizumab in a long-term observational study. BMC Nephrol. 2019 Apr 10;20(1):125. doi: 10.1186/s12882-019-1314-1.

location_country:
United Kingdom
Italy
Austria
Australia
Netherlands
Canada
Switzerland
Sweden
United States
France
Belgium
Germany

location_facility: Universitaetsklinikum Aachen Klinik fuer Nieren- und Hochdruckkrankheiten

location_facility: Dunwoody Pediatrics & Children's Healthcare of Atlanta

location_facility: Hopital de la Timone Enfants, Unité de Néphrologie

location_facility: INSELSPITAL Universitaetsklinik fuer Kinderheilkunde Kindernephrologie

location_facility: Centre Hospitalier Universitaire Pellegrin, Service de Nephrologie Transplantation Dialyse

location_facility: Radboud University Nijmegen Medical Centre Nijmegen

location_facility: Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico Maggiore Policlinico

location_facility: City Hospital, Nottingham University Hospitals, NHS Trust

location_facility: Le Centre Hospitalier Universitaire de Nice

location_facility: The Methodist Hospital Research Institute

location_facility: Centre Hospitalier Inter-Communal de Cornouaille

location_facility: Hopital Robert-Debré, Service de Néphrologie Pédiatrique

location_facility: Le Kremlin Bicetre Hospital, Nephrology Unit

location_facility: Centre Hospitalier Universitaire (CHU) Sainte-Justine

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Nephrology Clinic, Karolinska University Hospital

location_facility: Universitatsklinik fur Innere Medizin Medizinische Universitat Graz

location_facility: Centre Hospitalier Regional de la Source, Service de nephrologie/hemodialyse

location_facility: CHU-CH Charles Nicolle Pavillon de Pédiatrie

location_facility: Providence Sacred Heart Medical Center & Children's Hospital

status_simplified: Unknown


title: A Multinational, Randomised, Open-labelled, Parallel Group Four Months Comparison of Twice Daily Biphasic Human Insulin 30 and Thrice Daily Biphasic Insulin Aspart 50 and 70 in Subjects With Type 1 or Type 2 Diabetes

summary: This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.

ReferenceType: result

ReferenceCitation: Clements MR, Tits J, Kinsley BT, Råstam J, Friberg HH, Ligthelm RJ. Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes. Diabetes Obes Metab. 2008 Mar;10(3):229-37. doi: 10.1111/j.1463-1326.2006.00687.x.

lead_sponsor: Novo Nordisk A/S

location_country:
United Kingdom
Ireland
France
Belgium
Netherlands


title: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma

acronym: IMAGE

summary: The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting

ReferenceCitation: Dalle S, Mortier L, Corrie P, Lotem M, Board R, Arance AM, Meiss F, Terheyden P, Gutzmer R, Buysse B, Oh K, Brokaw J, Le TK, Mathias SD, Scotto J, Lord-Bessen J, Moshyk A, Kotapati S, Middleton MR. Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study. BMC Cancer. 2021 May 29;21(1):642. doi: 10.1186/s12885-021-08032-y.

ReferenceCitation: Middleton MR, Dalle S, Claveau J, Mut P, Hallmeyer S, Plantin P, Highley M, Kotapati S, Le TK, Brokaw J, Abernethy AP. Real-world treatment practice in patients with advanced melanoma in the era before ipilimumab: results from the IMAGE study. Cancer Med. 2016 Jul;5(7):1436-43. doi: 10.1002/cam4.717. Epub 2016 Apr 26.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Spain
Greece
Austria
Australia
Ireland
Argentina
Canada
Switzerland
United Kingdom
United States
France
Israel
Belgium
Germany

location_facility:
Mid Ohio Onc/Hem, Inc
Local Institutio
Local Institution
Local institution


acronym: Zevalin in patients with Diffuse Large B-cell Lymphoma

title: A Phase 3, Open-label, Multicenter, Randomized Study of Sequential Zevalin (Ibritumomab Tiuxetan) Versus Observation in Patients at Least 60 Years of Age With Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP or R-CHOP-like Therapy

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
Spain
Ireland
Austria
Australia
Italy
Canada
United Kingdom
Puerto Rico
United States
France
Israel
Belgium
Netherlands

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: Spaarne Ziekenhuis, Internal Medicine/Ocology

location_facility: Thunder Bay Regional Health Sciences Centre-Regional Cancer Care

location_facility: Nuclear Medicine Physician, Jules Bordet Institute

location_facility: Department of Haematology Bristol Royal Infirmary

location_facility: Azienda Ospedaliera San. Giovanni Battista di Torino, Dipartimento di Oncologia U.O.A Ematologia, Le Molinette,

location_facility: University Medical Center Radboud Nijmegen

location_facility: Oncology Research-Park Nicollet Institute

location_facility: Service d'Hématologie Centre Henri Becquerel

location_facility: Centre François Baclesse, Comite Hématologie

location_facility: Decatur Memorial Hospital Cancer Care Specialists of Central Illinois

location_facility: Policlinico S Orsola Malpighi, Istituto di Ematologia ''L.e A. Seragnoli''

location_facility: Hackensack UMC / John Theurer Cancer Center

location_facility: York Cancer Center / Cancer Care Associates of York

location_facility: Northwestern University Feinberg School of Medicine

location_facility: St. Luke's Mountain States Tumor Institute (MSTI)

location_facility: CH de la Côte Basque, Service d'Hématologie

location_facility: University Medical Centre Groningen (UMCG)

location_facility: University of Iowa Hospitals and Clinics

location_facility: New Ematologia dell'Ospedale "Spedali Civili" di Brescia

location_facility: The Christie NHS Foundation Trust, The Christie Hospital,

summary: The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy.


title: A Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)

acronym: LIBERATE

summary: The primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific Adverse Events (AEs) of interest from participants taking Fampyra in routine clinical practice. The secondary objectives of this study are to characterize utilization patterns of Fampyra in routine clinical practice, to assess the effectiveness of risk minimization measures as described in the risk management plan for Fampyra, to assess the change over time in participant self-reported evaluation of the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to assess the change over time in physician assessment of walking ability in participants taking Fampyra (MS participants only).

ReferenceCitation: Castelnovo G, Gerlach O, Freedman MS, Bergmann A, Sinay V, Castillo-Triviño T, Kong G, Koster T, Williams H, Gafson AR, Killestein J. Safety, Patient-Reported Well-Being, and Physician-Reported Assessment of Walking Ability in Patients with Multiple Sclerosis for Prolonged-Release Fampridine Treatment in Routine Clinical Practice: Results of the LIBERATE Study. CNS Drugs. 2021 Sep;35(9):1009-1022. doi: 10.1007/s40263-021-00840-x. Epub 2021 Jul 28.

lead_sponsor: Biogen

location_country:
Portugal
Spain
Ireland
Lebanon
Netherlands
Argentina
Canada
United Arab Emirates
France
Israel
Norway
Germany
Czechia

location_facility:
Research site
Reasearch Center
Site Research
Research Site
Rsearch Site


acronym: BOOST

intervention_type: Biological

title: A Prospective Randomised Phase III Trial to Evaluate Optimal Treatment Duration of First-line Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Primary Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

lead_sponsor: AGO Study Group

ReferenceCitation: Pfisterer J, Joly F, Kristensen G, Rau J, Mahner S, Pautier P, El-Balat A, Kurtz JE, Canzler U, Sehouli J, Heubner ML, Hartkopf AD, Baumann K, Hasenburg A, Hanker LC, Belau A, Schmalfeldt B, Denschlag D, Park-Simon TW, Selle F, Jackisch C, Burges A, Lück HJ, Emons G, Meier W, Gropp-Meier M, Schröder W, de Gregorio N, Hilpert F, Harter P. Optimal Treatment Duration of Bevacizumab as Front-Line Therapy for Advanced Ovarian Cancer: AGO-OVAR 17 BOOST/GINECO OV118/ENGOT Ov-15 Open-Label Randomized Phase III Trial. J Clin Oncol. 2022 Nov 4:JCO2201010. doi: 10.1200/JCO.22.01010. [Epub ahead of print]

location_country: Denmark Finland Sweden France Norway Germany

summary: The purpose of this study is to determine whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months.


acronym: MabCute

title: A Randomized Study Comparing Maintenance Therapy With Subcutaneous Rituximab Continued Until Progression With Observation Only in Patients With Relapsed or Refractory, Indolent Non-Hodgkin's Lymphoma Who Completed and Responded to Rituximab-based Immunochemotherapy Induction and Initial 2-year Rituximab Maintenance Therapy Administered Subcutaneously

ReferenceCitation: Rule S, Barreto WG, Briones J, Carella AM, Casasnovas O, Pocock C, Wendtner CM, Zaja F, Robson S, MacGregor L, Tschopp RR, Nick S, Dreyling M. Efficacy and safety assessment of prolonged maintenance with subcutaneous rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: results of the phase III MabCute study. Haematologica. 2022 Feb 1;107(2):500-509. doi: 10.3324/haematol.2020.274803.

ReferenceCitation: Theodore-Oklota C, Humphrey L, Wiesner C, Schnetzler G, Hudgens S, Campbell A. Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to subcutaneous administration of rituximab. Patient Prefer Adherence. 2016 Sep 13;10:1767-1776. eCollection 2016.

ReferenceCitation: Rule S, Collins GP, Samanta K. Subcutaneous vs intravenous rituximab in patients with non-Hodgkin lymphoma: a time and motion study in the United Kingdom. J Med Econ. 2014 Jul;17(7):459-68. doi: 10.3111/13696998.2014.914033. Epub 2014 May 7.

location_country:
Spain
Italy
United Kingdom
Lithuania
Romania
Albania
Slovenia
Austria
Russian Federation
Argentina
Turkey
Norway
Sweden
Slovakia
Egypt
Brazil
Switzerland
Hungary
Germany
Bulgaria
Greece
Ecuador
France
Colombia

location_facility: University College London, Department of Haematology

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia

location_facility: A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica

location_facility: Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel

location_facility: University "Mother Theresa" Hospital Center; Oncology Department

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

location_facility: St. Olavs Hospital HF, Kreftavdelingen, Gastrosentret

location_facility: Centre Antoine Lacassagne;B4 Hematologie Cancerologie

location_facility: Hospital Duran i Reynals; Servicio de Hematologia

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

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

location_facility: Ospedale Cardarelli; Divisione Di Ematologia

location_facility: Rus Med Academy for Postgraduate Education; Oncology Department

location_facility: Marmara University Pendik Training and Research Hospital, Hematology Department

location_facility: Hospital Univ. Central de Asturias; servicio de Hematologia

location_facility: Hamatol Onkol Praxisgemeinschaft Dres H H-D Schick/D Schick

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin

location_facility: A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1

location_facility: Az. Osp. Di Careggi; Divisione Di Ematologia

location_facility: Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio de Hematología

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: The Royal Marsden Hospital; Dept of Medicine

location_facility: Hopital Andre Mignot; Hematologie - Oncologie

location_facility: Hospital das Clinicas - FMUSP; Hematologia

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

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

location_facility: Spitalul Clinic Coltea; Clinica de Hematologie

location_facility: Regional Clinical Hospital N.A. Semashko; Hematology

location_facility: Leicester Royal Infirmary; Dept of Haematology

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia

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

location_facility: Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia

location_facility: County Clinical Emergency Hospital Brasov

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

location_facility: Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie

location_facility: Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia

location_facility: Hôpital Lapeyronie; Hématologie Oncologie Médicale

location_facility: Hospital Universitario de Canarias;servicio de Hematologia

location_facility: University of Pecs, I st Dept of Internal Medicine

location_facility: Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia

location_facility: University Hospital of Ioannina; Hematology

location_facility: Tokuda Hospital Sofia; Hematology department

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

location_facility: Uni of Debrecen; 2Nd Clinic of Internal Medicine

location_facility: Uni Hospital of Wales; Dept of Haematology

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

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Dres. Richard Hansen Susanne Pfitzner-Dempfle und Manfred Reeb

location_facility: A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica

location_facility: Hôpital Albert Michallon; Hematologie Clinique

location_facility: Royal Bournemouth General Hospital; Haematology

location_facility: Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan

location_facility: Centre Hospitalier Uni Ire; Service Des Maladies Du Sang

location_facility: CH Henri Mondor; Med Interne Neuro Endocrinologie

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

location_facility: Hopital Pitie Salpetriere; Hematologie Clinique

location_facility: Ch Sud Francilien; Hematologie Oncologie

location_facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

location_facility: Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie

location_facility: Södersjukhuset, Medicinkliniken/Sektionen för Hematologi

location_facility: Capio, S:T Gorans Hospital; Dept of Medicine

location_facility: Birmingham Heartlands Hospital; Department of Haematology

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

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

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

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: A.O. Universitaria S. Martino Di Genova; Ematologia 1

location_facility: Västmanlands sjukhus Västerås, Onkologmottagningen

location_facility: Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie

location_facility: Hospital Universitario San Cecilio; Servicio de Oncologia

location_facility: Kasr Eieny Uni Hospital; Oncology (Nemrock)

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: National Oncology Inst. ; Dept. of Haematology

location_facility: Centre Hospitalier de La Cote Basque; Hematologie

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Royal Marsden Hospital; Dept. of Medicine

location_facility: Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie

location_facility: Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer

location_facility: Norfolk & Norwich Hospital; Dept of Haematology

location_facility: Dres. Andreas Hübner, Andreas Lück und Petra Bruhn

location_facility: Instituto Nacional de Cancerologia; Hematology

location_facility: Hospital Quiron de Madrid; Servicio de Hematologia

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Teodoro Maldonado Carbo Hospital; Oncology Service

location_facility: Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)

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

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: Hospital de Jerez de la Frontera; Servicio de Hematologia

location_facility: General Hospital of Athens Evangelismos; Hematology

location_facility: St. Johannes Hospital; Abt. für Hämatologie und Onkologie

location_facility: Semmelweis University, First Dept of Medicine

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

location_facility: Ospedale Ferrarotto; Divisione Di Ematologia

location_facility: Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; III. Medizinische Abteilung

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Centro de Tratamento Oncologico - CETRON

location_facility: Hacettepe Uni Medical Faculty; Hematology

location_facility: Hospital San Pedro De Alcantara; Servicio de Hematologia

location_facility: University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division

location_facility: Hospital Royo Villanova; Servicio de Hematologia

location_facility: University Hospital of Larissa; Hematology Dept.

location_facility: Royal Liverpool Uni Hospital; Haematology

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

location_facility: Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.

location_facility: Kent & Canterbury Hospital; Clinical Haematology

location_facility: Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale

location_facility: Istanbul Uni Capa Medical Faculty; Inst. of Oncology

location_facility: Dres. Emil Höring Matthias Respondek und Ulrike Schwinger

location_facility: Uni Hospital ; Dept. of Haematol. & Transfusion Medicine

summary: This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter [mg/m^2] intravenously [IV] in Cycle 1, then 1400 mg subcutaneous [SC] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first.


title: International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Chemotherapy-treated Cancer Patients at Risk for Febrile Neutropenia and Treated Prophylactically With Filgrastim Biosimilar.

acronym: Monitor-GCSF

summary: This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically in physician's best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.

lead_sponsor: Sandoz

location_country:
Poland
Romania
Spain
Italy
Austria
United Kingdom
Czech Republic
Switzerland
Hungary
France
Belgium
Germany


title: Non-Interventional Cohort Study on the Utilization and Impact of Dual and Triple Therapies Based on Pegylated Interferon for the Treatment of Chronic Hepatitis C

summary: This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.

location_country: Macedonia, The Former Yugoslav Republic of


title: Electronic Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia: An International Prospective Observational Study (eAQUA)

summary:
This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia.

Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL

ReferenceType: background

ReferenceCitation: Mouysset JL, Freier B, van den Bosch J, Levaché CB, Bols A, Tessen HW, Belton L, Bohac GC, Terwey JH, Tonini G. Hemoglobin levels and quality of life in patients with symptomatic chemotherapy-induced anemia: the eAQUA study. Cancer Manag Res. 2016 Jan 21;8:1-10. doi: 10.2147/CMAR.S88110. eCollection 2016.

lead_sponsor: Amgen

location_country: Poland Romania Greece Austria Italy Netherlands France Belgium Germany


title: A Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy

summary: This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.

ReferenceCitation: Chen SC, Quartino A, Polhamus D, Riggs M, French J, Wang X, Vadhavkar S, Smitt M, Hoersch S, Strasak A, Jin JY, Girish S, Li C. Population pharmacokinetics and exposure-response of trastuzumab emtansine in advanced breast cancer previously treated with ≥2 HER2-targeted regimens. Br J Clin Pharmacol. 2017 Dec;83(12):2767-2777. doi: 10.1111/bcp.13381. Epub 2017 Sep 3.

ReferenceCitation: Krop IE, Kim SB, Martin AG, LoRusso PM, Ferrero JM, Badovinac-Crnjevic T, Hoersch S, Smitt M, Wildiers H. Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial. Lancet Oncol. 2017 Jun;18(6):743-754. doi: 10.1016/S1470-2045(17)30313-3. Epub 2017 May 16.

ReferenceCitation: Krop IE, Kim SB, González-Martín A, LoRusso PM, Ferrero JM, Smitt M, Yu R, Leung AC, Wildiers H; TH3RESA study collaborators. Trastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):689-99. doi: 10.1016/S1470-2045(14)70178-0. Epub 2014 May 2.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Poland
Russian Federation
Australia
India
Israel
Norway
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Czech Republic
Thailand
Korea, Republic of
France


acronym: ISIS-ICD

summary: ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up

ReferenceCitation: Ruiz-Granell R, Dovellini EV, Dompnier A, Khalighi K, García-Campo E, Olivier A, Barcelo A, Ritter P. Algorithm-based reduction of inappropriate defibrillator shock: Results of the Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator Study. Heart Rhythm. 2019 Sep;16(9):1429-1435. doi: 10.1016/j.hrthm.2019.03.016. Epub 2019 Mar 22.

lead_sponsor: MicroPort CRM

location_country:
Spain
Italy
United Kingdom
United States
France
Japan
Germany

location_facility: Centre Hospitalier Universitaire D'Amiens

location_facility: Southern California Electrophysiology Associates

location_facility: CHRU du Morvan Hôpital la Cavale Blanche

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Centre Hospitalier Universitaire de La Timone

location_facility: Universitatsklinikum Schleswig-Holstein Campus Lübeck

location_facility: CHU Groupe Hospitalo-universitaire Caremeau

location_facility: Policlinico Consorziale di Bari U.O Cardiologia Universitaria

location_facility: Pitt Memeorial Hospital Heart Rhythm Associates

location_facility: Kardiologische Praxis Dr. med Taggeselle

location_facility: Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH


title: Randomized Phase III Study of a Treatment Driven by Early PET Response Compared to a Treatment Not Monitored by Early PET in Patients With Ann Arbor Stage III-IV or High Risk IIB Hodgkin Lymphoma

summary:
All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine).

The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment

Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result.

ReferenceCitation: Casasnovas RO, Bouabdallah R, Brice P, Lazarovici J, Ghesquieres H, Stamatoullas A, Dupuis J, Gac AC, Gastinne T, Joly B, Bouabdallah K, Nicolas-Virelizier E, Feugier P, Morschhauser F, Sibon D, Bonnet C, Berriolo-Riedinger A, Edeline V, Parrens M, Damotte D, Coso D, André M, Meignan M, Rossi C. Positron Emission Tomography-Driven Strategy in Advanced Hodgkin Lymphoma: Prolonged Follow-Up of the AHL2011 Phase III Lymphoma Study Association Study. J Clin Oncol. 2022 Apr 1;40(10):1091-1101. doi: 10.1200/JCO.21.01777. Epub 2022 Jan 6.

ReferenceCitation: Demeestere I, Racape J, Dechene J, Dupuis J, Morschhauser F, De Wilde V, Lazarovici J, Ghesquieres H, Touati M, Sibon D, Alexis M, Gac AC, Moatti H, Virelizier E, Maisonneuve H, Pranger D, Houot R, Fornecker LM, Tempescul A, André M, Casasnovas RO. Gonadal Function Recovery in Patients With Advanced Hodgkin Lymphoma Treated With a PET-Adapted Regimen: Prospective Analysis of a Randomized Phase III Trial (AHL2011). J Clin Oncol. 2021 Oct 10;39(29):3251-3260. doi: 10.1200/JCO.21.00068. Epub 2021 Jun 22.

ReferenceCitation: Casasnovas RO, Bouabdallah R, Brice P, Lazarovici J, Ghesquieres H, Stamatoullas A, Dupuis J, Gac AC, Gastinne T, Joly B, Bouabdallah K, Nicolas-Virelizier E, Feugier P, Morschhauser F, Delarue R, Farhat H, Quittet P, Berriolo-Riedinger A, Tempescul A, Edeline V, Maisonneuve H, Fornecker LM, Lamy T, Delmer A, Dartigues P, Martin L, André M, Mounier N, Traverse-Glehen A, Meignan M. PET-adapted treatment for newly diagnosed advanced Hodgkin lymphoma (AHL2011): a randomised, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2019 Feb;20(2):202-215. doi: 10.1016/S1470-2045(18)30784-8. Epub 2019 Jan 15.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_country: France Belgium

location_facility: Hopitaux Civil de Colmar - Hopital Pasteur

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: CHU Haut Leveque - Centre François Magendie

location_facility: CHU de Strasbourg-Hopital de Hautepierre

location_facility: Institut Curie - Hopital Claudius Régaud

lead_sponsor_type: academique


title: A 30 Day International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase IV Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for PCI.

acronym: ATLANTIC

summary:
The aim of this study is to determine whether initiation of ticagrelor as early as in the ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the patient.

The study will assess the efficacy and safety of pre-hospital compared to in-hospital administration of ticagrelor in co-administration with aspirin, on restoring the blood flow in the occluded heart artery and improving the myocardial perfusion in patients suffering from myocardial infarction and planned to have a PCI. Patients can be randomised in either one of the 2 arms:

re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the pre-hospital administration and placebo for in-hospital administration.

or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital administration and 180 mg ticagrelor loading dose for in-hospital administration.

Patients are initially managed by ambulance physician/personnel in pre hospital settings. They are then transferred into a Catheterization room to undergo a PCI.

After the administration of the loading dose of ticagrelor (double blind), patients will continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.

ReferenceCitation: Montalescot G, van 't Hof AW, Lapostolle F, Silvain J, Lassen JF, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Goodman SG, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Zeymer U, Stibbe O, Ecollan P, Heutz WM, Swahn E, Collet JP, Willems FF, Baradat C, Licour M, Tsatsaris A, Vicaut E, Hamm CW; ATLANTIC Investigators. Prehospital ticagrelor in ST-segment elevation myocardial infarction. N Engl J Med. 2014 Sep 11;371(11):1016-27. doi: 10.1056/NEJMoa1407024. Epub 2014 Sep 1.

ReferenceCitation: Lapostolle F, Van't Hof AW, Hamm CW, Stibbe O, Ecollan P, Collet JP, Silvain J, Lassen JF, Heutz WMJM, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Goodman SG, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Ten Berg J, Zeymer U, Licour M, Tsatsaris A, Montalescot G; ATLANTIC Investigators. Morphine and Ticagrelor Interaction in Primary Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction: ATLANTIC-Morphine. Am J Cardiovasc Drugs. 2019 Apr;19(2):173-183. doi: 10.1007/s40256-018-0305-0.

ReferenceCitation: Fabris E, Van't Hof A, Hamm CW, Lapostolle F, Lassen JF, Goodman SG, Ten Berg JM, Bolognese L, Cequier A, Chettibi M, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Zeymer U, Cantor WJ, Kerneis M, Diallo A, Vicaut E, Montalescot G; ATLANTIC investigators. Pre-hospital administration of ticagrelor in diabetic patients with ST-elevation myocardial infarction undergoing primary angioplasty: A sub-analysis of the ATLANTIC trial. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):E369-E377. doi: 10.1002/ccd.27921. Epub 2018 Oct 9.

ReferenceCitation: Bagai A, Goodman SG, Cantor WJ, Vicaut E, Bolognese L, Cequier A, Chettibi M, Hammett CJ, Huber K, Janzon M, Lapostolle F, Lassen JF, Merkely B, Storey RF, Ten Berg JM, Zeymer U, Diallo A, Hamm CW, Tsatsaris A, El Khoury J, Van't Hof AW, Montalescot G. Duration of ischemia and treatment effects of pre- versus in-hospital ticagrelor in patients with ST-segment elevation myocardial infarction: Insights from the ATLANTIC study. Am Heart J. 2018 Feb;196:56-64. doi: 10.1016/j.ahj.2017.10.021. Epub 2017 Nov 4.

ReferenceCitation: Kilic S, Fabris E, Van't Hof AWJ, Hamm CW, Lapostolle F, Lassen JF, Tsatsaris A, Diallo A, Vicaut E, Montalescot G; ATLANTIC Investigators. Thrombus aspiration and prehospital ticagrelor administration in ST-elevation myocardial infarction: Findings from the ATLANTIC trial. Am Heart J. 2018 Feb;196:1-8. doi: 10.1016/j.ahj.2017.09.018. Epub 2017 Oct 3.

ReferenceCitation: Venetsanos D, Sederholm Lawesson S, Alfredsson J, Janzon M, Cequier A, Chettibi M, Goodman SG, Van't Hof AW, Montalescot G, Swahn E. Association between gender and short-term outcome in patients with ST elevation myocardial infraction participating in the international, prospective, randomised Administration of Ticagrelor in the catheterisation Laboratory or in the Ambulance for New ST elevation myocardial Infarction to open the Coronary artery (ATLANTIC) trial: a prespecified analysis. BMJ Open. 2017 Sep 21;7(9):e015241. doi: 10.1136/bmjopen-2016-015241.

ReferenceCitation: Cayla G, Lapostolle F, Ecollan P, Stibbe O, Benezet JF, Henry P, Hammett CJ, Lassen JF, Storey RF, Ten Berg JM, Hamm CW, Van't Hof AW, Montalescot G; ACTION study group. Pre-hospital ticagrelor in ST-segment elevation myocardial infarction in the French ATLANTIC population. Int J Cardiol. 2017 Oct 1;244:49-53. doi: 10.1016/j.ijcard.2017.06.009. Epub 2017 Jun 9.

ReferenceCitation: Lupi A, Schaffer A, Lazzero M, Tessitori M, De Martino L, Rognoni A, Bongo AS, Porto I. Pre-hospital ticagrelor in patients with ST-segment elevation myocardial infarction with long transport time to primary PCI facility. Cardiovasc Revasc Med. 2016 Dec;17(8):528-534. doi: 10.1016/j.carrev.2016.08.005. Epub 2016 Aug 20.

ReferenceCitation: Silvain J, Storey RF, Cayla G, Esteve JB, Dillinger JG, Rousseau H, Tsatsaris A, Baradat C, Salhi N, Hamm CW, Lapostolle F, Lassen JF, Collet JP, Ten Berg JM, Van't Hof AW, Montalescot G. P2Y12 receptor inhibition and effect of morphine in patients undergoing primary PCI for ST-segment elevation myocardial infarction. The PRIVATE-ATLANTIC study. Thromb Haemost. 2016 Aug 1;116(2):369-78. doi: 10.1160/TH15-12-0944. Epub 2015 May 19.

ReferenceCitation: Montalescot G, van 't Hof AW, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Collet JP, Goodman SG, Hammett CJ, Huber K, Janzon M, Lapostolle F, Lassen JF, Licour M, Merkely B, Salhi N, Silvain J, Storey RF, Ten Berg JM, Tsatsaris A, Zeymer U, Vicaut E, Hamm CW; ATLANTIC Investigators. Effect of Pre-Hospital Ticagrelor During the First 24 h After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction: The ATLANTIC-H²⁴ Analysis. JACC Cardiovasc Interv. 2016 Apr 11;9(7):646-56. doi: 10.1016/j.jcin.2015.12.024. Epub 2016 Mar 5.

ReferenceCitation: Montalescot G, Lassen JF, Hamm CW, Lapostolle F, Silvain J, ten Berg JM, Cantor WJ, Goodman SG, Licour M, Tsatsaris A, van't Hof AW. Ambulance or in-catheterization laboratory administration of ticagrelor for primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: rationale and design of the randomized, double-blind Administration of Ticagrelor in the cath Lab or in the Ambulance for New ST elevation myocardial Infarction to open the Coronary artery (ATLANTIC) study. Am Heart J. 2013 Apr;165(4):515-22. doi: 10.1016/j.ahj.2012.12.015. Epub 2013 Feb 13.

lead_sponsor: AstraZeneca

location_country:
Denmark
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Sweden
Hungary
Algeria
France
Germany


title: A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Disease in Subjects With Newly Diagnosed Multiple Myeloma

summary: The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.

primary_purpose: Supportive Care

ReferenceCitation: Raje N, Roodman GD, Willenbacher W, Shimizu K, García-Sanz R, Terpos E, Kennedy L, Sabatelli L, Intorcia M, Hechmati G. A cost-effectiveness analysis of denosumab for the prevention of skeletal-related events in patients with multiple myeloma in the United States of America. J Med Econ. 2018 May;21(5):525-536. doi: 10.1080/13696998.2018.1445634. Epub 2018 Mar 5.

ReferenceCitation: Raje N, Terpos E, Willenbacher W, Shimizu K, García-Sanz R, Durie B, Legieć W, Krejčí M, Laribi K, Zhu L, Cheng P, Warner D, Roodman GD. Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma: an international, double-blind, double-dummy, randomised, controlled, phase 3 study. Lancet Oncol. 2018 Mar;19(3):370-381. doi: 10.1016/S1470-2045(18)30072-X. Epub 2018 Feb 9.

ReferenceCitation: Huang SY, Yoon SS, Shimizu K, Chng WJ, Chang CS, Wong RS, Gao S, Wang Y, Gordon SW, Glennane A, Min CK. Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study-Asian Subgroup Analysis. Adv Ther. 2020 Jul;37(7):3404-3416. doi: 10.1007/s12325-020-01395-x. Epub 2020 Jun 10.

ReferenceCitation: Terpos E, Raje N, Croucher P, Garcia-Sanz R, Leleu X, Pasteiner W, Wang Y, Glennane A, Canon J, Pawlyn C. Denosumab compared with zoledronic acid on PFS in multiple myeloma: exploratory results of an international phase 3 study. Blood Adv. 2021 Feb 9;5(3):725-736. doi: 10.1182/bloodadvances.2020002378.

ipd_sharing: Yes

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

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Japan
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Turkey
Malaysia
Singapore
Slovakia
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Greece
Ireland
New Zealand
Korea, Republic of
France


title: LUMINOUS: Study to Observe the Effectiveness and Safety of Ranibizumab Through Individualized Patient Treatment and Associated Outcomes

acronym: LUMINOUS

summary: This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.

ReferenceCitation: Holz FG, Minnella AM, Tuli R, Yoganathan P, Parikh S, Hamilton R; LUMINOUS™ study group. Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study. PLoS One. 2020 Dec 30;15(12):e0244183. doi: 10.1371/journal.pone.0244183. eCollection 2020.

ReferenceCitation: Leys AM, Ramboer E, Favreau M, Denhaerynck K, MacDonald K, Abraham I, Brié H. Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUS(TM) Study. Clin Ophthalmol. 2020 Jun 2;14:1473-1481. doi: 10.2147/OPTH.S242547. eCollection 2020.

ReferenceCitation: Pearce I, Clemens A, Brent MH, Lu L, Gallego-Pinazo R, Minnella AM, Creuzot-Garcher C, Spital G, Sakamoto T, Dunger-Baldauf C, McAllister IL; all the LUMINOUS™ study investigators. Real-world outcomes with ranibizumab in branch retinal vein occlusion: The prospective, global, LUMINOUS study. PLoS One. 2020 Jun 18;15(6):e0234739. doi: 10.1371/journal.pone.0234739. eCollection 2020.

ReferenceCitation: Mitchell P, Sheidow TG, Farah ME, Mahmood S, Minnella AM, Eter N, Eldem B, Al-Dhibi H, Macfadden W, Parikh S, Dunger-Baldauf C, Mahgoub MM, Schmidt-Erfurth U; LUMINOUS study investigators. Effectiveness and safety of ranibizumab 0.5 mg in treatment-naïve patients with diabetic macular edema: Results from the real-world global LUMINOUS study. PLoS One. 2020 Jun 3;15(6):e0233595. doi: 10.1371/journal.pone.0233595. eCollection 2020.

ReferenceCitation: Schmidt-Erfurth U, Chong V, Loewenstein A, Larsen M, Souied E, Schlingemann R, Eldem B, Monés J, Richard G, Bandello F; European Society of Retina Specialists. Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA). Br J Ophthalmol. 2014 Sep;98(9):1144-67. doi: 10.1136/bjophthalmol-2014-305702. Review.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Ukraine
Venezuela
Costa Rica
Peru
Belgium
Japan
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
India
Israel
Panama
Turkey
Mexico
Malaysia
Singapore
Slovakia
Egypt
Brazil
Canada
Guatemala
Hungary
China
Germany
Dominican Republic
Greece
Ireland
Ecuador
Czech Republic
Korea, Republic of
France
Chile
Colombia
Netherlands

intervention_type: Other


title: BRIEF: Bendamustine and Rituximab In Elderly Follicular: A Multicentric Phase II Study Evaluating the Benefit of a Short Induction Treatment by Bendamustine and Rituximab Followed by Maintenance Therapy With Rituximab In Elderly (≥ 60 Years Old) Patients With Untreated Follicular Lymphoma Patients, With an Intermediate or High FLIPI Score

acronym: BRIEF

summary:
The objective of this study is to evaluate the complete response rate after a short induction treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in In Elderly (≥ 60 years old) patients with untreated Follicular lymphoma, with an intermediate or high FLIPI score and without high tumor burden.

This short induction is followed by a rituximab (375mg/m2)maintenance/ Induction schedule:Rituximab+Bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, rituximab on day 22, Bendamustine on Day 29, Bendamustine on Day 30 Maintenance schedule: 12 infusions of rituximab, each 8 weeks

ReferenceCitation: Gyan E, Sonet A, Brice P, Anglaret B, Laribi K, Fruchart C, Tilly H, Araujo C, Soubeyran P, Gonzalez H, Morineau N, Nicolas-Virelizier E, Ghesquières H, Salles B, Bouabdallah R, Orfeuvre H, Fahri J, Couturier O, Xerri L, Feugier P; Lymphoma Study Association (LYSA). Bendamustine and rituximab in elderly patients with low-tumour burden follicular lymphoma. Results of the LYSA phase II BRIEF study. Br J Haematol. 2018 Oct;183(1):76-86. doi: 10.1111/bjh.15513. Epub 2018 Aug 16.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: CHU LIMOGES - Hôpital Universitaire Dupuytren

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Centre Hospitalier de Wallonie Picarde - CHwapi

location_facility: Université Catholique de Louvain Saint Luc

location_facility: AZ Groeninge - Campus Maria's Voorzienigheid

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Clinique Victor Hugo - Centre Jean Bernard


title: Observational Study to Assess Clinical Management Patterns in Patients With Hospitalised Community-Acquired Pneumonia (CAP) or Complicated Skin and Skin Structure Infections (cSSSI)

acronym: REACH

summary: This study will collect real-life data from patients with community acquired pneumonia (CAP) OR complicated skin and skin structure infections (cSSSI) to assess the burden of the disease, review the treatment pathways, evaluate how health resources are used and identify any areas of unmet medical needs. The aim of the study is to compare how patients who are admitted to hospital with CAP or cSSSI are managed across Europe. This will be done by collecting data to understand the patient and disease characteristics, current practice of treatment, and outcomes for the patient. Overall 4000 patients will be recruited from 10 European countries.

time_perspective: Retrospective

ReferenceCitation: Garau J, Blasi F, Medina J, McBride K, Ostermann H; REACH study group. Early response to antibiotic treatment in European patients hospitalized with complicated skin and soft tissue infections: analysis of the REACH study. BMC Infect Dis. 2015 Feb 19;15:78. doi: 10.1186/s12879-015-0822-2.

ReferenceCitation: Blasi F, Ostermann H, Racketa J, Medina J, McBride K, Garau J; REACH study group. Early versus later response to treatment in patients with community-acquired pneumonia: analysis of the REACH study. Respir Res. 2014 Jan 22;15:6. doi: 10.1186/1465-9921-15-6.

ReferenceCitation: Blasi F, Garau J, Medina J, Ávila M, McBride K, Ostermann H; REACH study group. Current management of patients hospitalized with community-acquired pneumonia across Europe: outcomes from REACH. Respir Res. 2013 Apr 15;14:44. doi: 10.1186/1465-9921-14-44.

location_country:
Portugal
Spain
Italy
Greece
Netherlands
United Kingdom
France
Turkey
Belgium
Germany


title: Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma

summary: This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.

ReferenceCitation: Wang M, Ramchandren R, Chen R, Karlin L, Chong G, Jurczak W, Wu KL, Bishton M, Collins GP, Eliadis P, Peyrade F, Lee Y, Eckert K, Neuenburg JK, Tam CS. Concurrent ibrutinib plus venetoclax in relapsed/refractory mantle cell lymphoma: the safety run-in of the phase 3 SYMPATICO study. J Hematol Oncol. 2021 Oct 30;14(1):179. doi: 10.1186/s13045-021-01188-x.

lead_sponsor: Pharmacyclics LLC.

location_country:
Poland
Spain
Greece
Italy
Australia
Netherlands
Canada
United Kingdom
Ukraine
Hungary
Korea, Republic of
United States
France
Turkey
Belgium
Germany
Czechia

location_facility: Charite- Universitatsmedizin Berlin, Campus Benjamin Franklin

location_facility: Andrii Novak Transcarpathian Regional Clinical Hospital, Department of Hematology

location_facility: Gemeinschaftpraxis Haematologie und Onkologie

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika

location_facility: Markusovszky Egyetemi Oktatokorhaz, Haematologiai es Haemoszatazeologiai Osztaly

location_facility: Azienda Ospedaliero Universitaria Molinette San Giovanni Battista di Torino

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

location_facility: Vseobecna fakultni nemocnice v Praze, l. interni klinika-klinika hematologie

location_facility: Azienda Ospedaliera S. Croce e Carle Cuneo

location_facility: Gazi Universitesi Tip Fakultesi, Besevler

location_facility: Ondokuz Mayiz universitesi Tip Fakultesi

location_facility: The University of Arizona Cancer Centre-North Campus

location_facility: National Inst. of Cancer, Scientific and Research Dept of Chemotherapy of Hemoblastosis and Adjuvant Treatment Methods, Dept of Oncohematology with Sector of Adjuvant treatment methods

location_facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu, PZOZ

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: ZiekenhuisNetwerk Antwerpen (ZNA) Stuivenberg

location_facility: FN Brno, Interni hematologicka a onkologicka klinika

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico Saint Orsola Malpighi

location_facility: Namik Kemal Universitesi Saglik Uyg. ve.Ars. Hastanesi

location_facility: Queen Elizabeth II Health Science Centre

location_facility: Universitatsklinikum des Saarlandes, Klinik fur Innere Medizin I

location_facility: Universitaetsmedizin der Johannes Gutenberg, Langenbeckstrasse 1

location_facility: Hospital Universitari Germans Trias I Pujol

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

location_facility: Petz Aladar Megyei Oktato Korhaz, II. Belgyogyaszat-Hematologia

location_facility: Asst Grande Ospedale Metropolitano Niguarda

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Texas MD Anderson Cancer Center

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: Communal Nonprofit enterprise Cherkasy Regional Oncology Dispensary ofCherkasy Oblast Council,Regional Treatment and Diagnostic Hematological Center

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Klinikum der Universitaet Muenchen Campus Grosshadern

location_facility: Fakultni Nemocnice (FN) Hradec Kravlove, a.s. IV. Interni hematologicka klinika

location_facility: Communal Institution O.F. Herbachevskyi Regional Clinical Hospital of Zhytomyr Regional Council Dept of Hematology with beds of Intensive Therapy

location_facility: SI national Scientific Center of Radiation Medicine of NAMS of Ukraine, Dep. of Radiation Oncohematology and Stem Cell Transplantation Unit

location_facility: The University of Kansas Cancer Center and Medical Pavilion

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Oddzial Hematologiczny

location_facility: Nottingham University Hospitals NHS Trust

location_facility: UCLA Department of Medicine-Hematology/Oncology

location_facility: Universitatsklinikum Essen, Klinik fur Hamatologie

location_facility: ICO l'Hospitalet- Hospital Duran i Reynals

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

location_facility: Communal Non-profit Enterprise Regional Center of Oncology, Department of Hematology

location_facility: Kliniken Ostalb Stauferklinikum Schwab. Gmund

location_facility: Institut Paoli Calmettes, Service Hematologie

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria