title: ADVATE/ ADYNOVI Hemophilia A Outcome Database

acronym: AHEAD

summary: The purpose of the study is to document the natural history of hemophilia A disease and long-term outcomes in terms of effectiveness, safety and quality of life in participants receiving Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) or Antihemophilic Factor (Recombinant) - Pegylated (rAHF-PEG) in routine clinical practice

lead_sponsor: Baxalta now part of Shire

collaborators: Baxalta Innovations GmbH, now part of Shire

location_country:
Poland
Australia
Brazil
Czechia
Canada
France
Slovenia
Colombia
Portugal
Hungary
Denmark
Switzerland
Belgium
China
Italy
Norway
United Kingdom
Austria
Spain
Greece
Russian Federation
Sweden

location_facility: Azienda Ospedaliera Policlinico Consorziale Di Bari

location_facility: Azienda Ospedaliera di Padova Clinica Medica II

location_facility: Federal State Budget Institution "Hematology Research Center" of Ministry of Healthcare of Russian Federation

location_facility: FMH Kinder und Jugendmedizin, im Wabern-Zentrum

location_facility: Landes Frauen und Kinderklinik Linz (LFKK Linz)

location_facility: Kepler Universitätsklinikum Klinik für Kinder-und Jugendheilkunde

location_facility: IPS FUSA SAS Centro Integral de Coagulacion

location_facility: Università degli studi di Roma "La Sapienza"

location_facility: Hôpital de la Mère et de l'Enfant - CHU de LIMOGES

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: South Metropolitan Health Service trading as Fiona Stanley Hospital

location_facility: Hospital Universitari Vall d'Hebron (HUVH)

location_facility: Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital

location_facility: Hampshire Hospitals NHS Foundation Trust, Basingstoke and North Hampshire Hospital

location_facility: Stollery Children's Hospital, University of Alberta

location_facility: Beijing Children's Hospital Affiliated to Capital University of Medical Sciences

location_facility: Szpital Uniwersytecki nr 1 im. dr Andrzeja Jurasza

location_facility: Clinics of FSBEI High Education Samara SMU of MoH of Russia

location_facility: SBHI Chelyabinsk Regional Children's Clinical Hospital

location_facility: Kliniska studier i Sverige - Forum Söder

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Centro Hospitalar Lisboa Norte Hospital de Sta. Maria

location_facility: Institute of Hematology, Blood Disease Hospital, PUMC&CAMS

location_facility: Nanfang Hospital Affiliated to Nanfang Medical University

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

location_facility: General Hospital of Thessaloniki "Ippokratio"

location_facility: Centre Régional de Traitement de l'Hémophilie et des Maladies hémorragiques. CHU de Rennes - Hôpital Pontchaillou

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: State Budget Healthcare Institution of Saint-Petersburg "City polyclinic #37"

location_facility: Azienda Ospedaliera Universitaria Vittorio Emanuele, Ferrarotto, S. Bambino

location_facility: Centro Hospitalar e Universitade de Coimbra

location_facility: Faculdade de Medicina da Universidade de São Paulo

location_facility: Rikshospitalet, Oslo University Hospital

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: East Kent Hospitals University Foundation Trust, Kent & Canterbury Hospital

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: SBHI of the Republic of Kareliya Republican Hospital n.a. V.A. Baranov

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: CHU de Reims Hôpital Maison Blanche - CRTH

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: Uniwersytecki Szpital Kliniczny we Wrocławiu

location_facility: Fakultní nemocnice Ostrava, Oddělení dětské hematologie a hematoonkologie

location_facility: Hospital Teresa Herrera-Materno Infantil

location_facility: Great Ormond Street Hospital for Children NHS Trust

location_facility: Fundación Oftalmológica de Santander FOSCAL

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1


title: A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM)

acronym: ESTEEM

summary: The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Biogen

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Czechia
Canada
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Puerto Rico
Italy
Norway
United Kingdom
Netherlands
Austria
Spain

location_facility:
Research site
Research Site
Research Sites

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: MURANO

lead_sponsor: Hoffmann-La Roche

summary: The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B).

ReferenceType: derived

ReferenceCitation: Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Seymour JF, Kipps TJ, Eichhorst BF, D'Rozario J, Owen CJ, Assouline S, Lamanna N, Robak T, de la Serna J, Jaeger U, Cartron G, Montillo M, Mellink C, Chyla B, Panchal A, Lu T, Wu JQ, Jiang Y, Lefebure M, Boyer M, Kater AP. Enduring undetectable MRD and updated outcomes in relapsed/refractory CLL after fixed-duration venetoclax-rituximab. Blood. 2022 Aug 25;140(8):839-850. doi: 10.1182/blood.2021015014.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: American Society of Hematology

ReferenceCitation: Kater AP, Wu JQ, Kipps T, Eichhorst B, Hillmen P, D'Rozario J, Assouline S, Owen C, Robak T, de la Serna J, Jaeger U, Cartron G, Montillo M, Dubois J, Eldering E, Mellink C, Van Der Kevie-Kersemaekers AM, Kim SY, Chyla B, Punnoose E, Bolen CR, Assaf ZJ, Jiang Y, Wang J, Lefebure M, Boyer M, Humphrey K, Seymour JF. Venetoclax Plus Rituximab in Relapsed Chronic Lymphocytic Leukemia: 4-Year Results and Evaluation of Impact of Genomic Complexity and Gene Mutations From the MURANO Phase III Study. J Clin Oncol. 2020 Dec 1;38(34):4042-4054. doi: 10.1200/JCO.20.00948. Epub 2020 Sep 28.

evidence: open (via page says license)

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

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;escholarship.org

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Kater AP, Seymour JF, Hillmen P, Eichhorst B, Langerak AW, Owen C, Verdugo M, Wu J, Punnoose EA, Jiang Y, Wang J, Boyer M, Humphrey K, Mobasher M, Kipps TJ. Fixed Duration of Venetoclax-Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia Eradicates Minimal Residual Disease and Prolongs Survival: Post-Treatment Follow-Up of the MURANO Phase III Study. J Clin Oncol. 2019 Feb 1;37(4):269-277. doi: 10.1200/JCO.18.01580. Epub 2018 Dec 3.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Seymour JF, Kipps TJ, Eichhorst B, Hillmen P, D'Rozario J, Assouline S, Owen C, Gerecitano J, Robak T, De la Serna J, Jaeger U, Cartron G, Montillo M, Humerickhouse R, Punnoose EA, Li Y, Boyer M, Humphrey K, Mobasher M, Kater AP. Venetoclax-Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. N Engl J Med. 2018 Mar 22;378(12):1107-1120. doi: 10.1056/NEJMoa1713976.

oa_colors: green other

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Jones AK, Freise KJ, Agarwal SK, Humerickhouse RA, Wong SL, Salem AH. Clinical Predictors of Venetoclax Pharmacokinetics in Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma Patients: a Pooled Population Pharmacokinetic Analysis. AAPS J. 2016 Sep;18(5):1192-1202. doi: 10.1208/s12248-016-9927-9. Epub 2016 May 27.

oa_host_type: closed

repositories_concat: closed

sponsor_collaborators:
Hoffmann-La Roche
AbbVie

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Severance Hospital, Yonsei University Health System

location_facility: North-West Federal Medical Research Center n.a. V.A. Almazov

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: Centre Hospitalier Départemental Les Oudairies

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

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

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Saskatoon City Hospital;Saskatchewan Cancer Centre

location_facility: University of California San Diego Medical Center

location_facility: Albert Schweitzer Ziekenhuis, Dordwijk; Internal Medicine, Hemato-Oncology

location_facility: Azienda Ospedaliero Universitaria San Martino

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

location_facility: Cliniques Universitaires Saint-Luc; Hematology

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience

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

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Hospital Clinic i Provincial de Barcelona; Hematology

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Perlmutter Cancer Center NYU Langone Health

location_facility: Huntsman Cancer Institute; University of Utah

location_facility: Leids Universitair Medisch Centrum; Cardiology

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

location_facility: CHU Nantes - Hôtel Dieu; Service Assistance Medicale à la Procreation

location_facility: Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

location_facility: SP ZOZ Zespol Szpitali Miejskich w Chorzowie

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Memorial Sloan Kettering Cancer Center; Clinical Trials Office

location_facility: Asst Grande Ospedale Metropolitano Niguarda; SC Farmacia Ospedale

title: A Multicenter, Phase III, Open-Label, Randomized Study in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia to Evaluate the Benefit of Venetoclax (GDC-0199/ABT-199) Plus Rituximab Compared With Bendamustine Plus Rituximab

primary_purpose: Treatment

type: EudraCT Number

source: euctr

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical 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).

design_allocation: Randomized

location_country:
Germany
Poland
New Zealand
Australia
Czechia
Canada
France
Hungary
Denmark
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Sweden

study_type: Interventional

ipd_sharing: Yes


title: Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

summary:
The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen.

The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceCitation: Gomez SM, Varela MA, Ruiz C, Sung L. Comparable Outcomes of Matched Sibling Donor and Matched Unrelated Donor Stem Cell Transplantation in Children With Acute Leukemia in Argentina. J Pediatr Hematol Oncol. 2021 Oct 1;43(7):e1020-e1024. doi: 10.1097/MPH.0000000000002174.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Peters C, Dalle JH, Locatelli F, Poetschger U, Sedlacek P, Buechner J, Shaw PJ, Staciuk R, Ifversen M, Pichler H, Vettenranta K, Svec P, Aleinikova O, Stein J, Gungor T, Toporski J, Truong TH, Diaz-de-Heredia C, Bierings M, Ariffin H, Essa M, Burkhardt B, Schultz K, Meisel R, Lankester A, Ansari M, Schrappe M; IBFM Study Group;; von Stackelberg A; IntReALL Study Group; Balduzzi A; I-BFM SCT Study Group; Corbacioglu S; EBMT Paediatric Diseases Working Party; Bader P. Total Body Irradiation or Chemotherapy Conditioning in Childhood ALL: A Multinational, Randomized, Noninferiority Phase III Study. J Clin Oncol. 2021 Feb 1;39(4):295-307. doi: 10.1200/JCO.20.02529. Epub 2020 Dec 17.

license: cc-by

license_normalized: cc-by

repository_institution: University of Geneva - Archive ouverte UNIGE

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

repositories_institution: University of Geneva - Archive ouverte UNIGE

repositories_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available.

publisher_dissemination: Elsevier

ReferenceCitation: Choong E, Uppugunduri CRS, Marino D, Kuntzinger M, Doffey-Lazeyras F, Lo Piccolo R, Chalandon Y, Peters C, Daali Y, Ansari M. Therapeutic Drug Monitoring of Busulfan for the Management of Pediatric Patients: Cross-Validation of Methods and Long-Term Performance. Ther Drug Monit. 2018 Feb;40(1):84-92. doi: 10.1097/FTD.0000000000000468. Erratum In: Ther Drug Monit. 2018 Apr;40(2):284.

lead_sponsor: St. Anna Kinderkrebsforschung

collaborators: European Society for Blood and Marrow Transplantation

collaborators: Australian & New Zealand Children's Haematology/Oncology Group

sponsor_collaborators: European Society for Blood and Marrow Transplantation

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Turkey
Croatia
Chile
Czechia
Canada
France
Slovenia
Belarus
Slovakia
Hungary
Denmark
Switzerland
Romania
Belgium
Malaysia
Italy
Norway
Sweden
Netherlands
Austria
Mexico
Saudi Arabia
Spain
Greece
Israel

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

location_facility: Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie

location_facility: Universitätsklinik für Kinder- und Jugendmedizin Tübingen

location_facility: Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: A.O. San Gerardo di Monza Clinica Pediatrica

location_facility: Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin

location_facility: CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie Pédiatrique

location_facility: Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT

location_facility: UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie

location_facility: Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin

location_facility: Universitätsklinikum Jena, Sektion für Stammzelltransplantation

location_facility: A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia

location_facility: Cape of Hope, Wroclaw Medical University

location_facility: IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique

location_facility: Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM)

location_facility: University Children's Hospital, Dept. of Women's & Children's Health Section for Pediatrics

location_facility: CHU Nantes, Service d'onco hémato pédiatrie

location_facility: Skane University Hospital, Dept. of Pediatrics, Section for Hematology and Oncology

location_facility: CancerCare Manitoba/University of Manitoba

location_facility: Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology

location_facility: King Abdullah specialists children hospital

location_facility: Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman

location_facility: Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München

location_facility: Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique

location_facility: CHU Strasbourg, Service d'hématologie et d'oncologie pédiatrique

location_facility: Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin

location_facility: Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin

location_facility: Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO

location_facility: Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki

location_facility: Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O.

location_facility: Schneider Children's Medical Center of Israel

location_facility: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

location_facility: Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit

location_facility: Universitäts-Kinderspital beider Basel (UKBB)

location_facility: Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit

location_facility: Ankara University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Erciyes University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum

location_facility: Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University

location_facility: Istituto Gaslini Genova Oncoematologia Pediatrica-

location_facility: Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322)

location_facility: Azienda Ospedaliera di Padova Oncoematologia Pediatrica

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie

location_facility: Universitätsklinikum Erlangen, Kinder- und Jugendklinik

location_facility: Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet

location_facility: Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie

location_facility: Uniklinik RWTH Aachen, Kinder- und Jugendmedizin

location_facility: University of Malaya, Department of Paediatrics

location_facility: Klinikum der Universität München, Dr. von Haunersches Kinderspital

location_facility: Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABA

location_facility: Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

location_facility: Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde

location_facility: Children's Cancer Centre The Royal Children's Hospital

location_facility: Saint Sophia Children's Hospital BMT Unit

location_facility: University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric Transplantology

location_facility: CHRU Lille, Service d'Hématologie Pédiatrique

location_facility: The Children's Hospital at Westmead Oncology Unit

location_facility: Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit

location_facility: University of Medicine and Pharmacy V. BABES, Emergency Children's Hospital LOUIS TURCANU, III. Clinic of Pediatrics , Department of Onco-hematology and Bone Marrow Transplantation

location_facility: Princess Máxima Center for Pediatric Oncology

location_facility: CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant

location_facility: Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: Hospital Universitario Central de Asturias

location_facility: Leiden University Medical Center Department of Pediatrics/BMT unit

location_facility: Universitätsklinikum Essen, Klinik für Kinderheilkunde III

location_facility: St. Anna Children's Hospital, Vienna, Austria

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie

location_facility: Hospital for Sick Children University of Toronto Division of Haematology/Oncology

location_facility: Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin

location_facility: University Children's Hospital in Krakow, Department of Transplantation

location_facility: Hospital of Southern Pest, National Insitute of Hematology and Infectious DiseaseHospital of Southern Pest, National Insitute of Hematology and Infectious Disease Pediatric Bone Marrow Transplantation Unit at Central

location_facility: Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin

location_facility: IInsitutul Clinic Fundeni, Sectia de Transplant Medular

location_facility: Karolinska University Hospital, Department of Pediatrics

location_facility: University Hospital Gent Pediatrische hemato-oncologie

location_facility: Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie

location_facility: Gazi University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: University Hospitals Leuven Kinderhemato-oncologie

location_facility: Ospedale Pediatrico Bambino Gesù, Sapienza, University of Rome

location_facility: Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti

location_facility: CHU Sainte-Justine Hematology-Oncology Division

location_facility: Ege University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Alberta Children's Hospital Division of Pediatric Oncology

status_simplified: Ongoing


title: An Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat as a Single Agent in Subjects With Advanced Solid Tumors or With B-cell Lymphomas and Tazemetostat in Combination With Prednisolone in Subjects With Diffuse Large B Cell Lymphoma

summary: This is an open-label, multicenter, Phase 1/2 study of tazemetostat as a single agent in subjects with advanced solid tumors or with B-cell lymphomas and tazemetostat in combination with prednisolone in subjects with diffuse large B-cell lymphoma (DLBCL).

ReferenceCitation: Morschhauser F, Tilly H, Chaidos A, McKay P, Phillips T, Assouline S, Batlevi CL, Campbell P, Ribrag V, Damaj GL, Dickinson M, Jurczak W, Kazmierczak M, Opat S, Radford J, Schmitt A, Yang J, Whalen J, Agarwal S, Adib D, Salles G. Tazemetostat for patients with relapsed or refractory follicular lymphoma: an open-label, single-arm, multicentre, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1433-1442. doi: 10.1016/S1470-2045(20)30441-1. Epub 2020 Oct 6.

ReferenceCitation: Italiano A, Soria JC, Toulmonde M, Michot JM, Lucchesi C, Varga A, Coindre JM, Blakemore SJ, Clawson A, Suttle B, McDonald AA, Woodruff M, Ribich S, Hedrick E, Keilhack H, Thomson B, Owa T, Copeland RA, Ho PTC, Ribrag V. Tazemetostat, an EZH2 inhibitor, in relapsed or refractory B-cell non-Hodgkin lymphoma and advanced solid tumours: a first-in-human, open-label, phase 1 study. Lancet Oncol. 2018 May;19(5):649-659. doi: 10.1016/S1470-2045(18)30145-1. Epub 2018 Apr 9.

lead_sponsor: Epizyme, Inc.

location_country:
Germany
Italy
Poland
United Kingdom
Australia
United States
Taiwan
Canada
Ukraine
France


type: Other Identifier

title: The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes. A 52-week Randomised, Treat-to-target, Placebo-controlled, Double Blinded, Parallel Group, Multinational, Multi-centre Trial

acronym: ADJUNCT ONE™

summary: This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks.

ReferenceType: result

ReferenceCitation: Mathieu C, Zinman B, Hemmingsson JU, Woo V, Colman P, Christiansen E, Linder M, Bode B; ADJUNCT ONE Investigators. Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial. Diabetes Care. 2016 Oct;39(10):1702-10. doi: 10.2337/dc16-0691. Epub 2016 Aug 9.

oa_host_type: publisher

evidence: open (via free pdf)

publisher_dissemination: American Diabetes Association

ReferenceCitation: Dejgaard TF, von Scholten BJ, Christiansen E, Kreiner FF, Bardtrum L, von Herrath M, Mathieu C, Madsbad S; ADJUNCT ONE and ADJUNCT TWO Investigators. Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials. Diabetes Obes Metab. 2021 Dec;23(12):2752-2762. doi: 10.1111/dom.14532. Epub 2021 Sep 28. Erratum In: Diabetes Obes Metab. 2022 Nov;24(11):2280.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

publisher_dissemination: Wiley

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Germany
Ireland
Poland
Israel
Argentina
Norway
Australia
Sweden
Netherlands
United Kingdom
Belgium
United States
Canada
Ukraine
Russian Federation
France


title: GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation

summary:
After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.

There are two medication strategies:

Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR
Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely

ReferenceType: background

ReferenceCitation: Vranckx P, Valgimigli M, Juni P, Hamm C, Steg PG, Heg D, van Es GA, McFadden EP, Onuma Y, van Meijeren C, Chichareon P, Benit E, Mollmann H, Janssens L, Ferrario M, Moschovitis A, Zurakowski A, Dominici M, Van Geuns RJ, Huber K, Slagboom T, Serruys PW, Windecker S; GLOBAL LEADERS Investigators. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. Lancet. 2018 Sep 15;392(10151):940-949. doi: 10.1016/S0140-6736(18)31858-0. Epub 2018 Aug 27.

ReferenceCitation: Ono M, Hara H, Kawashima H, Gao C, Wang R, Wykrzykowska JJ, Piek JJ, Garg S, Hamm C, Steg PG, Valgimigli M, Windecker S, Vranckx P, Onuma Y, Serruys PW. Ticagrelor monotherapy versus aspirin monotherapy at 12 months after percutaneous coronary intervention: a landmark analysis of the GLOBAL LEADERS trial. EuroIntervention. 2022 Aug 5;18(5):e377-e388. doi: 10.4244/EIJ-D-21-00870.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: Gragnano F, Zwahlen M, Vranckx P, Heg D, Schmidlin K, Hamm C, Steg PG, Gargiulo G, McFadden EP, Onuma Y, Chichareon P, Benit E, Mollmann H, Janssens L, Leonardi S, Zurakowski A, Arrivi A, Van Geuns RJ, Huber K, Slagboom T, Calabro P, Serruys PW, Juni P, Valgimigli M, Windecker S; GLOBAL LEADERS Investigators [Link]. Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2022 May 17;11(10):e024291. doi: 10.1161/JAHA.121.024291. Epub 2022 Mar 1.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: UHasselt - Document Server@UHasselt

repository_institution: Radboud University - Radboud Repository

unpaywall_oa_status: gold

ReferenceCitation: Westra J, Eftekhari A, Renkens M, Mejia-Renteria H, Sejr-Hansen M, Stegehuis V, Holm NR, de Winter RJ, Piek JJ, Escaned J, Wykrzykowska JJ, Christiansen EH. Characterization of quantitative flow ratio and fractional flow reserve discordance using doppler flow and clinical follow-up. Int J Cardiovasc Imaging. 2022 Jan 18. doi: 10.1007/s10554-022-02522-1. Online ahead of print.

ReferenceCitation: Vranckx P, Valgimigli M, Odutayo A, Serruys PW, Hamm C, Steg PG, Heg D, Mc Fadden EP, Onuma Y, Benit E, Janssens L, Diletti R, Ferrario M, Huber K, Raber L, Windecker S, Juni P; GLOBAL LEADERS Investigators. Efficacy and Safety of Ticagrelor Monotherapy by Clinical Presentation: Pre-Specified Analysis of the GLOBAL LEADERS Trial. J Am Heart Assoc. 2021 Sep 21;10(18):e015560. doi: 10.1161/JAHA.119.015560. Epub 2021 Sep 17.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Gao C, Tomaniak M, Takahashi K, Kawashima H, Wang R, Hara H, Ono M, Montalescot G, Garg S, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, van Geuns RJ, Hamm C, Steg PG, Onuma Y, Angiolillo DJ, Serruys PW. Ticagrelor monotherapy in patients with concomitant diabetes mellitus and chronic kidney disease: a post hoc analysis of the GLOBAL LEADERS trial. Cardiovasc Diabetol. 2020 Oct 16;19(1):179. doi: 10.1186/s12933-020-01153-x.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

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

ReferenceCitation: Kawashima H, Tomaniak M, Ono M, Wang R, Hara H, Gao C, Takahashi K, Sharif F, Thury A, Suryapranata H, Walsh S, Cotton J, Carrie D, Sabate M, Steinwender C, Leibundgut G, Wykrzykowska J, de Winter RJ, Garg S, Hamm C, Steg PG, Juni P, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW. Safety and Efficacy of 1-Month Dual Antiplatelet Therapy (Ticagrelor + Aspirin) Followed by 23-Month Ticagrelor Monotherapy in Patients Undergoing Staged Percutaneous Coronary Intervention (A Sub-Study from GLOBAL LEADERS). Am J Cardiol. 2021 Jan 1;138:1-10. doi: 10.1016/j.amjcard.2020.09.057. Epub 2020 Oct 13.

ReferenceCitation: Gao C, Takahashi K, Garg S, Hara H, Wang R, Kawashima H, Ono M, Montalescot G, Haude M, Slagboom T, Vranckx P, Valgimigli M, Windecker S, Hamm C, Steg PG, Storey R, van Geuns RJ, Tao L, Onuma Y, Serruys PW. Regional variation in patients and outcomes in the GLOBAL LEADERS trial. Int J Cardiol. 2021 Feb 1;324:30-37. doi: 10.1016/j.ijcard.2020.09.039. Epub 2020 Sep 15.

ReferenceCitation: Hara H, Takahashi K, Kogame N, Tomaniak M, Kerkmeijer LSM, Ono M, Kawashima H, Wang R, Gao C, Wykrzykowska JJ, de Winter RJ, Neumann FJ, Plante S, Lemos Neto PA, Garg S, Juni P, Vranckx P, Windecker S, Valgimigli M, Hamm C, Steg PG, Onuma Y, Serruys PW. Impact of Bleeding and Myocardial Infarction on Mortality in All-Comer Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2020 Sep;13(9):e009177. doi: 10.1161/CIRCINTERVENTIONS.120.009177. Epub 2020 Aug 25.

ReferenceCitation: Hara H, van Klaveren D, Takahashi K, Kogame N, Chichareon P, Modolo R, Tomaniak M, Ono M, Kawashima H, Wang R, Gao C, Niethammer M, Fontos G, Angioi M, Ribeiro VG, Barbato E, Leandro S, Hamm C, Valgimigli M, Windecker S, Juni P, Steg PG, Verbeeck J, Tijssen JGP, Sharif F, Onuma Y, Serruys PW; GLOBAL LEADERS Trial Investigators. Comparative Methodological Assessment of the Randomized GLOBAL LEADERS Trial Using Total Ischemic and Bleeding Events. Circ Cardiovasc Qual Outcomes. 2020 Aug;13(8):e006660. doi: 10.1161/CIRCOUTCOMES.120.006660. Epub 2020 Jul 30.

ReferenceCitation: Ono M, Chichareon P, Tomaniak M, Kawashima H, Takahashi K, Kogame N, Modolo R, Hara H, Gao C, Wang R, Walsh S, Suryapranata H, da Silva PC, Cotton J, Koning R, Akin I, Rensing BJWM, Garg S, Wykrzykowska JJ, Piek JJ, Juni P, Hamm C, Steg PG, Valgimigli M, Windecker S, Storey RF, Onuma Y, Vranckx P, Serruys PW. The association of body mass index with long-term clinical outcomes after ticagrelor monotherapy following abbreviated dual antiplatelet therapy in patients undergoing percutaneous coronary intervention: a prespecified sub-analysis of the GLOBAL LEADERS Trial. Clin Res Cardiol. 2020 Sep;109(9):1125-1139. doi: 10.1007/s00392-020-01604-1. Epub 2020 Jan 31.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

ReferenceCitation: Tomaniak M, Chichareon P, Klimczak-Tomaniak D, Takahashi K, Kogame N, Modolo R, Wang R, Ono M, Hara H, Gao C, Kawashima H, Rademaker-Havinga T, Garg S, Curzen N, Haude M, Kochman J, Gori T, Montalescot G, Angiolillo DJ, Capodanno D, Storey RF, Hamm C, Vranckx P, Valgimigli M, Windecker S, Onuma Y, Serruys PW, Anderson R. Impact of renal function on clinical outcomes after PCI in ACS and stable CAD patients treated with ticagrelor: a prespecified analysis of the GLOBAL LEADERS randomized clinical trial. Clin Res Cardiol. 2020 Jul;109(7):930-943. doi: 10.1007/s00392-019-01586-9. Epub 2020 Jan 10.

ReferenceCitation: Tomaniak M, Chichareon P, Takahashi K, Kogame N, Modolo R, Chang CC, Spitzer E, Neumann FJ, Plante S, Hernandez Antolin R, Jambrik Z, Gelev V, Brunel P, Konteva M, Beygui F, Morelle JF, Filipiak KJ, van Geuns RJ, Soliman O, Tijssen J, Rademaker-Havinga T, Storey RF, Hamm C, Steg PG, Windecker S, Onuma Y, Valgimigli M, Serruys PW; GLOBAL LEADERS Study Investigators. Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial. Eur Heart J Cardiovasc Pharmacother. 2020 Jul 1;6(4):222-230. doi: 10.1093/ehjcvp/pvz052.

ReferenceCitation: Tomaniak M, Chichareon P, Modolo R, Takahashi K, Chang CC, Kogame N, Spitzer E, Buszman PE, van Geuns RM, Valkov V, Steinwender C, Geisler T, Prokopczuk J, Sabate M, Zmudka K, Rademaker-Havinga T, Tijssen JGP, Juni P, Hamm C, Steg PG, Onuma Y, Vranckx P, Valgimigli M, Windecker S, Baber U, Anderson R, Dominici M, Serruys PW. Ticagrelor monotherapy beyond one month after PCI in ACS or stable CAD in elderly patients: a pre-specified analysis of the GLOBAL LEADERS trial. EuroIntervention. 2020 Apr 3;15(18):e1605-e1614. doi: 10.4244/EIJ-D-19-00699.

ReferenceCitation: Chichareon P, Modolo R, Kerkmeijer L, Tomaniak M, Kogame N, Takahashi K, Chang CC, Komiyama H, Moccetti T, Talwar S, Colombo A, Maillard L, Barlis P, Wykrzykowska J, Piek JJ, Garg S, Hamm C, Steg PG, Juni P, Valgimigli M, Windecker S, Onuma Y, Mehran R, Serruys PW. Association of Sex With Outcomes in Patients Undergoing Percutaneous Coronary Intervention: A Subgroup Analysis of the GLOBAL LEADERS Randomized Clinical Trial. JAMA Cardiol. 2020 Jan 1;5(1):21-29. doi: 10.1001/jamacardio.2019.4296.

ReferenceCitation: Takahashi K, Serruys PW, Chichareon P, Chang CC, Tomaniak M, Modolo R, Kogame N, Magro M, Chowdhary S, Eitel I, Zweiker R, Ong P, Ottesen MM, Tijssen JGP, Wykrzykowska JJ, de Winter RJ, Garg S, Stoll HP, Hamm C, Steg PG, Onuma Y, Valgimigli M, Vranckx P, Carrie D, Windecker S. Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI. J Am Coll Cardiol. 2019 Oct 22;74(16):2015-2027. doi: 10.1016/j.jacc.2019.08.997.

ReferenceCitation: Tomaniak M, Chichareon P, Onuma Y, Deliargyris EN, Takahashi K, Kogame N, Modolo R, Chang CC, Rademaker-Havinga T, Storey RF, Dangas GD, Bhatt DL, Angiolillo DJ, Hamm C, Valgimigli M, Windecker S, Steg PG, Vranckx P, Serruys PW; GLOBAL LEADERS Trial Investigators. Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial. JAMA Cardiol. 2019 Nov 1;4(11):1092-1101. doi: 10.1001/jamacardio.2019.3355.

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

ReferenceCitation: Serruys PW, Tomaniak M, Chichareon P, Modolo R, Kogame N, Takahashi K, Chang CC, Spitzer E, Walsh SJ, Adlam D, Hildick-Smith D, Edes I, van de Harst P, Krackhardt F, Tijssen JGP, Rademaker-Havinga T, Garg S, Steg PG, Hamm C, Juni P, Vranckx P, Onuma Y, Verheugt FWA. Patient-oriented composite endpoints and net adverse clinical events with ticagrelor monotherapy following percutaneous coronary intervention: insights from the randomised GLOBAL LEADERS trial. EuroIntervention. 2019 Dec 20;15(12):e1090-e1098. doi: 10.4244/EIJ-D-19-00202.

ReferenceCitation: Leonardi S, Franzone A, Piccolo R, McFadden E, Vranckx P, Serruys P, Benit E, Liebetrau C, Janssens L, Ferrario M, Zurakowski A, van Geuns RJ, Dominici M, Huber K, Slagboom T, Buszman P, Bolognese L, Tumscitz C, Bryniarski K, Aminian A, Vrolix M, Petrov I, Garg S, Naber C, Prokopczuk J, Hamm C, Steg G, Heg D, Juni P, Windecker S, Valgimigli M. Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY). BMJ Open. 2019 Mar 9;9(3):e026053. doi: 10.1136/bmjopen-2018-026053.

repository_institution: Academy of Humanities and Economics in Lodz - Homo Politicus

sponsor_collaborators:
ECRI bv
Biosensors International
AstraZeneca
The Medicines Company

location_country:
Germany
Italy
Poland
Portugal
Hungary
Singapore
Denmark
Australia
Brazil
Netherlands
Austria
Belgium
Switzerland
United Kingdom
Spain
Bulgaria
Canada
France

location_facility: Research centre Villingen - Schwenningen, 4919


summary: This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.

ReferenceCitation: Ou SI, Gadgeel SM, Barlesi F, Yang JC, De Petris L, Kim DW, Govindan R, Dingemans AM, Crino L, Lena H, Popat S, Ahn JS, Dansin E, Mitry E, Muller B, Bordogna W, Balas B, Morcos PN, Shaw AT. Pooled overall survival and safety data from the pivotal phase II studies (NP28673 and NP28761) of alectinib in ALK-positive non-small-cell lung cancer. Lung Cancer. 2020 Jan;139:22-27. doi: 10.1016/j.lungcan.2019.10.015. Epub 2019 Oct 14.

ReferenceCitation: Morcos PN, Nueesch E, Jaminion F, Guerini E, Hsu JC, Bordogna W, Balas B, Mercier F. Exposure-response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer. Cancer Chemother Pharmacol. 2018 Jul;82(1):129-138. doi: 10.1007/s00280-018-3597-5. Epub 2018 May 10.

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Gadgeel SM, Shaw AT, Govindan R, Gandhi L, Socinski MA, Camidge DR, De Petris L, Kim DW, Chiappori A, Moro-Sibilot DL, Duruisseaux M, Crino L, De Pas T, Dansin E, Tessmer A, Yang JC, Han JY, Bordogna W, Golding S, Zeaiter A, Ou SI. Pooled Analysis of CNS Response to Alectinib in Two Studies of Pretreated Patients With ALK-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Dec;34(34):4079-4085. doi: 10.1200/JCO.2016.68.4639. Epub 2016 Oct 31. Erratum In: J Clin Oncol. 2017 May 10;35(14):1631.

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement

location_facility: CHU de Grenoble - Hôpital Nord; Service d'Oncologie Thoracique

location_facility: Royal Marsden Hospital;Dept of Haematology Oncology Research

location_facility: Severance Hospital, Yonsei University Health System; Pharmacy

location_facility: Midwestern Regional Medical Center; Office of Research

location_facility: Hôpital Nord - AP-HM Marseille#; Gastroenterology and Hepatology

location_facility: Charité Campus Virchow-Klinikum; Department of Cardiology

location_facility: National University Hospital; Investigational Medicine Unit

location_facility: Hospital Regional Universitario de Malaga

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

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Columbia University Medical Center; Department of Hematology/Oncology

location_facility: Maastricht University Medical Centre; Afdeling Klinische Farmacie en Toxicologie

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

location_facility: University Hospitals Case Medical Center

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: UCLA Cancer Center; Premiere Oncology, A Medical Corporation

title: An Open-Label, Non-Randomized, Multicenter Phase I/II Trial of RO5424802 Given Orally to Non-Small Cell Lung Cancer Patients Who Have ALK Mutation and Who Have Failed Crizotinib Treatment

location_country:
Germany
Italy
United Kingdom
Singapore
Denmark
Australia
Sweden
Netherlands
Belgium
United States
Korea, Republic of
Spain
Luxembourg
Taiwan
Russian Federation
France


title: A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus

summary: This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

ReferenceCitation: Hadjadj S, Rosenstock J, Meinicke T, Woerle HJ, Broedl UC. Initial Combination of Empagliflozin and Metformin in Patients With Type 2 Diabetes. Diabetes Care. 2016 Oct;39(10):1718-28. doi: 10.2337/dc16-0522. Epub 2016 Aug 4.

lead_sponsor: Boehringer Ingelheim

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_country:
Germany
Brazil
Thailand
Turkey
Canada
Serbia
France
Czech Republic
United States
Lebanon
Malaysia
Peru
Philippines
Egypt
Guatemala
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility: 1276.1.20003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34034 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10035 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.66001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.50003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34028 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34027 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34051 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33013 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10030 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38106 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.95004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10046 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34050 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.95001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10015 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.66002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.50005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.95002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70011 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10011 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10033 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38101 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10018 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10021 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10016 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70015 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10040 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10032 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10019 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10028 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.51005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49012 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10023 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34048 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49011 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.50006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34045 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10017 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.96004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.66003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10022 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70013 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.95003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.96003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.51002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.50002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10042 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10044 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20013 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10026 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10045 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.51003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.96001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70012 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20012 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70017 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70018 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.96002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33012 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10024 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.60002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.60003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38108 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.51001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44011 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10043 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10012 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10036 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10041 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38104 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38102 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49014 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38105 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10027 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34052 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10014 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33011 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.50001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.51004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10037 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10034 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.60001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38103 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38107 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70016 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10025 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10013 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42002 Boehringer Ingelheim Investigational Site


acronym: STRATUS

lead_sponsor: Celgene

summary:
The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.

The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years.

In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses.

The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.

ReferenceCitation: Dimopoulos MA, Palumbo A, Corradini P, Cavo M, Delforge M, Di Raimondo F, Weisel KC, Oriol A, Hansson M, Vacca A, Blanchard MJ, Goldschmidt H, Doyen C, Kaiser M, Petrini M, Anttila P, Cafro AM, Raymakers R, San-Miguel J, de Arriba F, Knop S, Rollig C, Ocio EM, Morgan G, Miller N, Simcock M, Peluso T, Herring J, Sternas L, Zaki MH, Moreau P. Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma. Blood. 2016 Jul 28;128(4):497-503. doi: 10.1182/blood-2016-02-700872. Epub 2016 May 25.

ReferenceCitation: Moreau P, Dimopoulos MA, Richardson PG, Siegel DS, Cavo M, Corradini P, Weisel K, Delforge M, O'Gorman P, Song K, Chen C, Bahlis N, Oriol A, Hansson M, Kaiser M, Anttila P, Raymakers R, Joao C, Cook G, Sternas L, Biyukov T, Slaughter A, Hong K, Herring J, Yu X, Zaki M, San-Miguel J. Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. Eur J Haematol. 2017 Sep;99(3):199-206. doi: 10.1111/ejh.12903. Epub 2017 Jun 14.

ReferenceCitation: Qian X, Dimopoulos MA, Amatangelo M, Bjorklund C, Towfic F, Flynt E, Weisel KC, Ocio EM, Yu X, Peluso T, Sternas L, Zaki M, Moreau P, Thakurta A. Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS. Leuk Lymphoma. 2019 Feb;60(2):462-470. doi: 10.1080/10428194.2018.1485915. Epub 2018 Aug 2.

ReferenceCitation: Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. doi: 10.1080/10428194.2016.1177181. Epub 2016 Jun 7.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories:
LIRIAS (KU Leuven)
Zenodo

repositories_concat: LIRIAS (KU Leuven);Zenodo

repositories_institution:
INFN Catania - INFM-OAR
KU Leuven - Lirias

publisher_dissemination: Informa

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Universitatsklinik MuensterMedizinische Klinik A

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Akademia Medyczna w Gdansku Katedra i Klinika Hematologii i Transplantologii

location_facility: Cork University HospitalHaematology Consultant

location_facility: Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie

location_facility: University Hospital Bratislava - Hospital Ss Cyril and Methodius

location_facility: Service Hemato-Immunologie Hopital St Louis

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Abt Haematologie - Onkologie / Allg. Krankenhaus Altona

location_facility: Oslo University Hospital, Rikshospitalet HF

location_facility: Hospital Geral de Santo António - Serviço de Hematologia Clínica

location_facility: Hospital Clinico Universitario De Santiago De Compostela

location_facility: Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: Azienda Ospedaliera San Giovanni Battista - Ospedale Molinette

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Belfast City Hospital Haematology Department

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Instytut Hematologii i Transfuzjologii w Warszawie

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

location_facility: ASST Grande Ospedale Metropolitano Niguarda, Milano

location_facility: Charite, Campus Benjamin Franklin Universitatsmedizin Berlin

location_facility: VU University Medical Center VU Medisch Centrum

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

title: A Multicenter, Single-arm, Open-label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma

location_country:
Finland
Germany
Ireland
Poland
Turkey
France
Portugal
Slovakia
Denmark
Switzerland
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Greece
Sweden


title: High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN)

summary:
This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified > 12 months at diagnosis).

The protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomization - isotretinoin and ch14.18/CHO (Dinutuximab beta, Qarziba ®).), with or without s.c. aldesleukin (IL-2)). Patients diagnosed after the closure of R3 randomization will not be R4 randomized. For these patients the use of ch14.18/CHO antibody is recommended without scIL-2 as continuous infusion as standard of care outside of controlled trials. ch14.18/CHO received marketing authorization by EMA in May 2017 (Qarziba ®).

In the induction phase, all patients receive Rapid COJEC following the result of the R3 randomization which was closed on June 8th, 2017 after inclusion of 630 patients as planned.

Following induction treatment peripheral blood stem cell harvest (PBSCH) is performed and complete excision of the primary tumour will be attempted.

Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles.

After Rapid COJEC induction, localized patients will proceed to consolidation. Patients aged 12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without segmental chromosomal alterations (SCAs) are thought to have a good prognosis and will stop treatment after induction therapy and surgery to the primary tumour.

Consolidation consists of BuMel MAT based on the results of the R1 randomization followed by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary tumour.

The R2 immunotherapy randomization using ch14.18/CHO as 8 hour infusion on 5 consecutive days ( total dose (100mg/m²) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) is closed.

The amended R4 immunotherapy randomization using ch14.18/CHO as continuous infusion (total dose 100mg/m² over 10 days) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) has accrued according to plan with results pending awaiting data maturity and DMC approval.

ReferenceCitation: Ladenstein R, Valteau-Couanet D, Brock P, Yaniv I, Castel V, Laureys G, Malis J, Papadakis V, Lacerda A, Ruud E, Kogner P, Garami M, Balwierz W, Schroeder H, Beck-Popovic M, Schreier G, Machin D, Potschger U, Pearson A. Randomized Trial of prophylactic granulocyte colony-stimulating factor during rapid COJEC induction in pediatric patients with high-risk neuroblastoma: the European HR-NBL1/SIOPEN study. J Clin Oncol. 2010 Jul 20;28(21):3516-24. doi: 10.1200/JCO.2009.27.3524. Epub 2010 Jun 21.

ReferenceCitation: Ladenstein R, Potschger U, Pearson ADJ, Brock P, Luksch R, Castel V, Yaniv I, Papadakis V, Laureys G, Malis J, Balwierz W, Ruud E, Kogner P, Schroeder H, de Lacerda AF, Beck-Popovic M, Bician P, Garami M, Trahair T, Canete A, Ambros PF, Holmes K, Gaze M, Schreier G, Garaventa A, Vassal G, Michon J, Valteau-Couanet D; SIOP Europe Neuroblastoma Group (SIOPEN). Busulfan and melphalan versus carboplatin, etoposide, and melphalan as high-dose chemotherapy for high-risk neuroblastoma (HR-NBL1/SIOPEN): an international, randomised, multi-arm, open-label, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):500-514. doi: 10.1016/S1470-2045(17)30070-0. Epub 2017 Mar 2.

ReferenceCitation: Ladenstein R, Potschger U, Valteau-Couanet D, Luksch R, Castel V, Yaniv I, Laureys G, Brock P, Michon JM, Owens C, Trahair T, Chan GCF, Ruud E, Schroeder H, Beck Popovic M, Schreier G, Loibner H, Ambros P, Holmes K, Castellani MR, Gaze MN, Garaventa A, Pearson ADJ, Lode HN. Interleukin 2 with anti-GD2 antibody ch14.18/CHO (dinutuximab beta) in patients with high-risk neuroblastoma (HR-NBL1/SIOPEN): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Dec;19(12):1617-1629. doi: 10.1016/S1470-2045(18)30578-3. Epub 2018 Nov 12.

ReferenceCitation: Morgenstern DA, Potschger U, Moreno L, Papadakis V, Owens C, Ash S, Pasqualini C, Luksch R, Garaventa A, Canete A, Elliot M, Wieczorek A, Laureys G, Kogner P, Malis J, Ruud E, Beck-Popovic M, Schleiermacher G, Valteau-Couanet D, Ladenstein R. Risk stratification of high-risk metastatic neuroblastoma: A report from the HR-NBL-1/SIOPEN study. Pediatr Blood Cancer. 2018 Nov;65(11):e27363. doi: 10.1002/pbc.27363. Epub 2018 Jul 17.

ReferenceCitation: Berbegall AP, Bogen D, Potschger U, Beiske K, Bown N, Combaret V, Defferrari R, Jeison M, Mazzocco K, Varesio L, Vicha A, Ash S, Castel V, Coze C, Ladenstein R, Owens C, Papadakis V, Ruud E, Amann G, Sementa AR, Navarro S, Ambros PF, Noguera R, Ambros IM. Heterogeneous MYCN amplification in neuroblastoma: a SIOP Europe Neuroblastoma Study. Br J Cancer. 2018 May;118(11):1502-1512. doi: 10.1038/s41416-018-0098-6. Epub 2018 May 14.

repository_institution: University of Oslo - Duo Research Archive

version: submittedVersion

repositories_concat: PubMed Central;www.duo.uio.no

ReferenceCitation: Mueller I, Ehlert K, Endres S, Pill L, Siebert N, Kietz S, Brock P, Garaventa A, Valteau-Couanet D, Janzek E, Hosten N, Zinke A, Barthlen W, Varol E, Loibner H, Ladenstein R, Lode HN. Tolerability, response and outcome of high-risk neuroblastoma patients treated with long-term infusion of anti-GD2 antibody ch14.18/CHO. MAbs. 2018 Jan;10(1):55-61. doi: 10.1080/19420862.2017.1402997. Epub 2017 Dec 5.

ReferenceCitation: Ladenstein R, Potschger U, Valteau-Couanet D, Luksch R, Castel V, Ash S, Laureys G, Brock P, Michon JM, Owens C, Trahair T, Chi Fung Chan G, Ruud E, Schroeder H, Beck-Popovic M, Schreier G, Loibner H, Ambros P, Holmes K, Castellani MR, Gaze MN, Garaventa A, Pearson ADJ, Lode HN. Investigation of the Role of Dinutuximab Beta-Based Immunotherapy in the SIOPEN High-Risk Neuroblastoma 1 Trial (HR-NBL1). Cancers (Basel). 2020 Jan 28;12(2):309. doi: 10.3390/cancers12020309.

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

repositories_concat: PubMed Central;www.lenus.ie

publisher_dissemination: MDPI

ReferenceCitation: Bellini A, Potschger U, Bernard V, Lapouble E, Baulande S, Ambros PF, Auger N, Beiske K, Bernkopf M, Betts DR, Bhalshankar J, Bown N, de Preter K, Clement N, Combaret V, Font de Mora J, George SL, Jimenez I, Jeison M, Marques B, Martinsson T, Mazzocco K, Morini M, Muhlethaler-Mottet A, Noguera R, Pierron G, Rossing M, Taschner-Mandl S, Van Roy N, Vicha A, Chesler L, Balwierz W, Castel V, Elliott M, Kogner P, Laureys G, Luksch R, Malis J, Popovic-Beck M, Ash S, Delattre O, Valteau-Couanet D, Tweddle DA, Ladenstein R, Schleiermacher G. Frequency and Prognostic Impact of ALK Amplifications and Mutations in the European Neuroblastoma Study Group (SIOPEN) High-Risk Neuroblastoma Trial (HR-NBL1). J Clin Oncol. 2021 Oct 20;39(30):3377-3390. doi: 10.1200/JCO.21.00086. Epub 2021 Jun 11.

repository_institution: Instituto Nacional de Saúde Doutor Ricardo Jorge - Scientific Repository of the National Health Institute Doutor Ricardo Jorge

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Holmes K, Potschger U, Pearson ADJ, Sarnacki S, Cecchetto G, Gomez-Chacon J, Squire R, Freud E, Bysiek A, Matthyssens LE, Metzelder M, Monclair T, Stenman J, Rygl M, Rasmussen L, Joseph JM, Irtan S, Avanzini S, Godzinski J, Bjornland K, Elliott M, Luksch R, Castel V, Ash S, Balwierz W, Laureys G, Ruud E, Papadakis V, Malis J, Owens C, Schroeder H, Beck-Popovic M, Trahair T, Forjaz de Lacerda A, Ambros PF, Gaze MN, McHugh K, Valteau-Couanet D, Ladenstein RL; International Society of Paediatric Oncology Europe Neuroblastoma Group (SIOPEN). Influence of Surgical Excision on the Survival of Patients With Stage 4 High-Risk Neuroblastoma: A Report From the HR-NBL1/SIOPEN Study. J Clin Oncol. 2020 Sep 1;38(25):2902-2915. doi: 10.1200/JCO.19.03117. Epub 2020 Jul 8.

ReferenceCitation: Viprey VF, Gregory WM, Corrias MV, Tchirkov A, Swerts K, Vicha A, Dallorso S, Brock P, Luksch R, Valteau-Couanet D, Papadakis V, Laureys G, Pearson AD, Ladenstein R, Burchill SA. Neuroblastoma mRNAs predict outcome in children with stage 4 neuroblastoma: a European HR-NBL1/SIOPEN study. J Clin Oncol. 2014 Apr 1;32(10):1074-83. doi: 10.1200/JCO.2013.53.3604. Epub 2014 Mar 3.

location_country:
Ireland
Poland
Australia
Czechia
France
Slovenia
Portugal
Slovakia
Hungary
Denmark
Switzerland
Belgium
Italy
Norway
United Kingdom
Sweden
Austria
Spain
Greece
Israel

location_facility: Glasgow Royal Hospital for Sick Children

location_facility: Aberdeen: Royal Aberdeen Children's Hospital

location_facility: University Children's Hospital Ljubljana

location_facility: Schneider Children's Medical Center of Israel

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Sec. Univ. degli Studi di Napoli - Policlinico

location_facility: Liverpool: Alder Hey Children's Hospital

location_facility: Istituto per l'Infanzia "Burlo Garofolo"

location_facility: Clinica di Oncoematologia Pediatrica Padova

location_facility: Univ.-Klinik für Kinder- und Jugendheilkunde Graz

location_facility: Children's University Hospital in Lublin

location_facility: Univ.Klinik f. Kinder-u. Jugendheilkunde Innsbruck

location_facility: Edinburgh Royal Hospital for Sick Children

location_facility: Upper Silesian Centre of Child and Mother's Care

location_facility: Azienda Ospedaliera Universitaria di Parma-Oncoematologia Pediatrica


title: A Multicenter, Open Label, Randomized Phase II Trial of the MEK Inhibitor Pimasertib or Dacarbazine in Previously Untreated Subjects With N-Ras Mutated Locally Advanced or Metastatic Malignant Cutaneous Melanoma

summary: This is a Phase 2, multicenter, randomized, controlled, open-label trial of pimasertib versus dacarbazine aimed to confirm the activity of pimasertib in previously untreated subjects with N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma by comparing the progression-free survival (PFS) of subjects treated with either pimasertib or dacarbazine and by getting a better understanding of the efficacy, safety, pharmacogenomics (PGx) and their relationship with pimasertib exposure.

ReferenceCitation: Lebbe C, Dutriaux C, Lesimple T, Kruit W, Kerger J, Thomas L, Guillot B, Braud F, Garbe C, Grob JJ, Loquai C, Ferraresi V, Robert C, Vasey P, Conry R, Isaacs R, Espinosa E, Schueler A, Massimini G, Dreno B. Pimasertib Versus Dacarbazine in Patients With Unresectable NRAS-Mutated Cutaneous Melanoma: Phase II, Randomized, Controlled Trial with Crossover. Cancers (Basel). 2020 Jun 29;12(7):1727. doi: 10.3390/cancers12071727.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repositories_concat: PubMed Central;pure.eur.nl;repub.eur.nl

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

lead_sponsor: EMD Serono

sponsor_collaborators:
EMD Serono
Merck KGaA, Darmstadt, Germany

location_country:
Germany
Italy
New Zealand
Israel
United Kingdom
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
South Africa
France

location_facility: Please contact the US Medical Information in


acronym: coBRIM

summary: To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.

ReferenceCitation: Barteselli G, Goodman GR, Patel Y, Caro I, Xue C, McCallum S. Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies. Drug Saf. 2022 Dec;45(12):1491-1499. doi: 10.1007/s40264-022-01248-2. Epub 2022 Oct 30.

ReferenceCitation: Ascierto PA, Dreno B, Larkin J, Ribas A, Liszkay G, Maio M, Mandala M, Demidov L, Stroyakovskiy D, Thomas L, de la Cruz-Merino L, Atkinson V, Dutriaux C, Garbe C, Hsu J, Jones S, Li H, McKenna E, Voulgari A, McArthur GA. 5-Year Outcomes with Cobimetinib plus Vemurafenib in BRAFV600 Mutation-Positive Advanced Melanoma: Extended Follow-up of the coBRIM Study. Clin Cancer Res. 2021 Oct 1;27(19):5225-5235. doi: 10.1158/1078-0432.CCR-21-0809.

repository_institution: University of Seville - Deposito de Investigacion Universidad de Sevilla

repositories_concat: PubMed Central;idus.us.es

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Ascierto PA, Ribas A, Larkin J, McArthur GA, Lewis KD, Hauschild A, Flaherty KT, McKenna E, Zhu Q, Mun Y, Dreno B. Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib +/- cobimetinib: a pooled analysis of four clinical trials. J Transl Med. 2020 Aug 3;18(1):294. doi: 10.1186/s12967-020-02458-x.

repository_normalized: University of Melbourne - Minerva Access

repository_normalized: HAL

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

repository_institution: University of California - eScholarship University of California

repositories: University of Melbourne - Minerva Access

repositories_concat: HAL;PubMed Central;University of Melbourne - Minerva Access;escholarship.org

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

ReferenceCitation: de la Cruz-Merino L, Di Guardo L, Grob JJ, Venosa A, Larkin J, McArthur GA, Ribas A, Ascierto PA, Evans JTR, Gomez-Escobar A, Barteselli G, Eng S, Hsu JJ, Uyei A, Dreno B. Clinical features of serous retinopathy observed with cobimetinib in patients with BRAF-mutated melanoma treated in the randomized coBRIM study. J Transl Med. 2017 Jun 24;15(1):146. doi: 10.1186/s12967-017-1246-0.

repository_institution: University of Melbourne - Minerva Access

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;eprints.gla.ac.uk;escholarship.org;www.repositoriosalud.es

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Dreno B, Ribas A, Larkin J, Ascierto PA, Hauschild A, Thomas L, Grob JJ, Koralek DO, Rooney I, Hsu JJ, McKenna EF, McArthur GA. Incidence, course, and management of toxicities associated with cobimetinib in combination with vemurafenib in the coBRIM study. Ann Oncol. 2017 May 1;28(5):1137-1144. doi: 10.1093/annonc/mdx040.

ReferenceCitation: Ascierto PA, McArthur GA, Dreno B, Atkinson V, Liszkay G, Di Giacomo AM, Mandala M, Demidov L, Stroyakovskiy D, Thomas L, de la Cruz-Merino L, Dutriaux C, Garbe C, Yan Y, Wongchenko M, Chang I, Hsu JJ, Koralek DO, Rooney I, Ribas A, Larkin J. Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. Lancet Oncol. 2016 Sep;17(9):1248-60. doi: 10.1016/S1470-2045(16)30122-X. Epub 2016 Jul 30.

ReferenceCitation: Larkin J, Ascierto PA, Dreno B, Atkinson V, Liszkay G, Maio M, Mandala M, Demidov L, Stroyakovskiy D, Thomas L, de la Cruz-Merino L, Dutriaux C, Garbe C, Sovak MA, Chang I, Choong N, Hack SP, McArthur GA, Ribas A. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014 Nov 13;371(20):1867-76. doi: 10.1056/NEJMoa1408868. Epub 2014 Sep 29.

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Nottingham University Hospitals; QMC Campus

location_facility: TSBHI Altai Territorial oncological dispensary

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Northwestern Center For Clinical Research

location_facility: Fakultni nemocnice Motol; Neurologicka klinika

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Juravinski Cancer Clinic; Department of Oncology

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: Centre Hospitalier Universitaire de Grenoble - Albert Michallon

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: FSBSI "N. N. Blokhin Russian Cancer Research Center"

location_facility: Rhode Island Hospital; Investigational Services

location_facility: Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari

location_facility: Uni of Kansas Medical Center; Dept of Neurology

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte

location_facility: Klinikum der Ludwigs-Maximilians-Universitaet Muenchen

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Hospital General Universitario de Valencia

location_facility: Tel Aviv Sourasky MC, Dana children's hospital;Oncology Division

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: The Ottawa Hospital Cancer Center; General Campus

location_facility: U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: Rabin Medical Center-Beilinson Campus;Hematology-Oncology

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

location_facility: The Angeles Clinic and Research Institute - W LA Office

location_facility: Institut Jules Bordet; Department of Medical Oncology

location_facility: Hospital Clínic i Provincial de Barcelona

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

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: HADASSAH UNIVERSITY HOSPITAL, EIN KAREM; Oncology

location_facility: McGill University Health Centre/Glen Site / Royal Victoria Hospital

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory

location_facility: BC Cancer Agency Vancouver Island Cancer Centre

location_facility: Leids Universitair Medisch Centrum; Cardiology

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin

location_facility: Princess Margaret Hospital; Department of Med Oncology

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

location_facility: University of California Davis Health System

location_facility: Dartmouth-Hitchcock Medical Center; Department of Medicine

location_facility: Launceston General Hospital; Gastroenterology Research

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Lismore Base Hospital; Cancer Care & Haematology Unit

location_facility: London Health Sciences Centre · Victoria Hospital;Department of Pediatrics

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

title: A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

location_country:
Germany
New Zealand
Australia
Czechia
Canada
France
Hungary
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Russian Federation
Israel


title: A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy

acronym: BEYOND

summary: The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Finland
Germany
Ireland
Poland
Armenia
Turkey
Czechia
Canada
France
Slovenia
Belarus
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
Latvia
Ukraine
Lebanon
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Bulgaria
Georgia
Russian Federation
Kazakhstan


title: An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary: The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.

ReferenceCitation: Crestani B, Huggins JT, Kaye M, Costabel U, Glaspole I, Ogura T, Song JW, Stansen W, Quaresma M, Stowasser S, Kreuter M. Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med. 2019 Jan;7(1):60-68. doi: 10.1016/S2213-2600(18)30339-4. Epub 2018 Sep 14.

location_country:
Finland
Germany
Ireland
Australia
Japan
Turkey
Chile
Czechia
Canada
France
Portugal
United States
India
Belgium
China
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Russian Federation
Israel

location_facility: General Hospital of Shenyang Military Region

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente

location_facility: National Allergy Asthma Bronchitis Institute, Kolkata

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Saitama Cardiovascular and Respiratory Center

location_facility: Xiangya Hospital, Central South University

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

location_facility: Mehta Hospital & Cardiopulmonary Care Centre

location_facility: University of Texas Southwestern Medical Center

location_facility: University Hospital of Heraklion, University Pulmonology Cl

location_facility: Kobe City Medical Center General Hospital

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: Scientific Research Institute of Pulmonology

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Athens Hospital of Chest Diseases "Sotiria"

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

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: General Hospital of Ningxia Medical University


lead_sponsor: Valerio Therapeutics

summary: The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to treat chemoradiation therapy induced severe oral mucositis in patients with head and neck cancer.

location_facility: California Cancer Associates for Researche and Excellence

location_facility: Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza

location_facility: Washington University School of medecine

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Universitatsklinikum Freiburg Klinik fur Strahlentherapie

location_facility: University of Oklahoma Health Sciences Center

location_facility: Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.

location_facility: Carolinas Medical Center- Carolinas Health Care System

title: A Phase II, Multi-center, Randomised, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Clonidine Lauriad® 50 μg and 100 μg Mucoadhesive Buccal Tablet (MBT) Applied Once Daily to Those of Placebo in the Prevention and Treatment of Chemoradiation Therapy Induced Oral Mucositis in Patients With Head and Neck Cancer

location_country:
Germany
Hungary
Switzerland
United States
Spain
France