acronym: VIALE-T

lead_sponsor: AbbVie

summary:
The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT).

This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).

location_facility: IEO -Istituto Europeo di Oncologia /ID# 242579

location_facility: UCHSC Anschultz Cancer Pavilion /ID# 215618

location_facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 216148

location_facility: Children's Hospital of Philadelphia - Main /ID# 215410

location_facility: General Hospital of Athens Evangelismos /ID# 238810

location_facility: Taipei Veterans General Hosp /ID# 239289

location_facility: Fukushima Medical University Hospital /ID# 252293

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939

location_facility: Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145

location_facility: Roswell Park Comprehensive Cancer Center /ID# 217857

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359

location_facility: Universitaetsklinikum Muenster /ID# 215213

location_facility: China Medical University Hospital /ID# 215198

location_facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591

location_facility: University of Mississippi Medical Center /ID# 239343

location_facility: Princess Margaret Cancer Centre /ID# 215344

location_facility: National Cancer Center Hospital /ID# 242639

location_facility: Peking University People's Hospital /ID# 215551

location_facility: Arizona Oncology - Scottsdale - Cancer Transplant Institute /ID# 239711

location_facility: University of Oklahoma, Stephenson Cancer Center /ID# 215611

location_facility: Massachusetts General Hospital /ID# 215765

location_facility: University General Hospital of Patras /ID# 238811

location_facility: Hospital Clinico Universitario de Valencia /ID# 215106

location_facility: University Hospitals - Seidman Cancer Center /ID# 239260

location_facility: Seoul National University Hospital /ID# 214891

location_facility: Zhujiang Hospital of Southern Medical University /ID# 216333

location_facility: Weill Cornell Medical College /ID# 214887

location_facility: Linkou Chang Gung Memorial Hospital /ID# 215319

location_facility: Hokkaido University Hospital /ID# 215937

location_facility: Nanfang Hospital of Southern Medical University /ID# 215553

location_facility: Universitaetsklinikum Wuerzburg /ID# 215212

location_facility: University of Fukui Hospital /ID# 253383

location_facility: Colorado Blood Cancer Institute /ID# 215980

location_facility: AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680

location_facility: King's College Hospital NHS Foundation Trust /ID# 215338

location_facility: TriStar Centennial Medical Center /ID# 218750

location_facility: Fred Hutchinson Cancer Research Center /ID# 214436

location_facility: Universitaetsklinikum Leipzig /ID# 245892

location_facility: Jichi Medical University Hospital /ID# 216091

location_facility: Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735

location_facility: Karmanos Cancer Institute - Dresner Clinic /ID# 214581

location_facility: Hospital de Clinicas de Porto Alegre /ID# 215042

location_facility: Zhongda Hospital Southeast University /ID# 218926

location_facility: The Royal Marsden NHS Foundation Trust /ID# 215124

location_facility: Xiangya Hospital Central South University /ID# 219025

location_facility: The University of Chicago Medical Center /ID# 215616

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373

location_facility: Columbia University Medical Center /ID# 240875

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 217522

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 214055

location_facility: Hospital General Universitario Gregorio Maranon /ID# 215107

location_facility: Ustav hematologie a krevni transfuze /ID# 215133

location_facility: NHS Greater Glasgow and Clyde /ID# 215663

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254964

location_facility: Loyola University Medical Ctr /ID# 215617

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 214060

location_facility: Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840

location_facility: Hyogo Medical University Hospital /ID# 215389

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 217916

location_facility: Yamagata University Hospital /ID# 253304

location_facility: Ochsner Clinic Foundation-New Orleans /ID# 213834

location_facility: Hospital Universitario Virgen del Rocio /ID# 215463

location_facility: Tel Aviv Sourasky Medical Center /ID# 214508

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 241123

location_facility: Hospital Santa Creu i Sant Pau /ID# 240397

location_facility: Fakultni nemocnice Hradec Kralove /ID# 214814

location_facility: ASST Spedali civili di Brescia /ID# 215997

location_facility: Jichi Medical University Saitama Medical Center /ID# 216092

location_facility: Indiana Blood & Marrow Transpl /ID# 215842

location_facility: Penn State Hershey Medical Ctr /ID# 217120

location_facility: Kanazawa University Hospital /ID# 242955

location_facility: The Affiliated Hospital of Xuzhou Medical University /ID# 239098

location_facility: Hospital Universitario Ramon y Cajal /ID# 218102

location_facility: Kobe City Medical Center General Hospital /ID# 215388

location_facility: Hadassah Medical Center-Hebrew University /ID# 218697

location_facility: CHU de Nice - Hôpital Archet 1 /ID# 214056

location_facility: CHU de Besancon - Jean Minjoz /ID# 241171

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 239516

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546

location_facility: National Center for Child Health and Development /ID# 242479

location_facility: Chinese PLA General Hospital /ID# 216287

location_facility: Perelman Center for Advanced Medicine - /ID# 214518

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197

location_facility: Imperial College Healthcare NHS Trust /ID# 215665

location_facility: University of Arkansas for Medical Sciences /ID# 239804

location_facility: University General Hospital Attikon /ID# 238812

location_facility: University College London Hospitals NHS Foundation Trust /ID# 215662

location_facility: Shenzhen Second People's Hospital /ID# 239401

location_facility: National Taiwan University Hospital /ID# 215245

location_facility: Osaka Metropolitan University Hospital /ID# 215227

location_facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 239203

location_facility: University of Maryland Med Ctr /ID# 213855

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214892

location_facility: Taichung Veterans General Hospital /ID# 239288

location_facility: Medizinische Hochschule Hannover /ID# 214243

location_facility: The First Affiliated Hospital of Nanchang University /ID# 239168

location_facility: Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 216096

location_facility: Oregon Health & Science University /ID# 215874

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 215253

location_facility: Texas Oncology - Medical City Dallas /ID# 216720

location_facility: University of Arizona Cancer Center - Tucson /ID# 242507

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550

location_facility: Schneider Children's Medical Center /ID# 224326

location_facility: Universitaetsklinikum Halle (Saale) /ID# 239585

location_facility: The First Affiliated Hospital of Soochow University /ID# 216605

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 215120

location_facility: Universitaetsklinik Heidelberg /ID# 216623

location_facility: University of North Carolina /ID# 215814

location_facility: Hospital Universitario La Paz /ID# 218103

location_facility: Montefiore Medical Center - Moses Campus /ID# 241669

location_facility: The Chaim Sheba Medical Center /ID# 214305

location_facility: Hospital Clinic de Barcelona /ID# 215108

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552

location_facility: AP-HP - Hopital Saint-Antoine /ID# 216957

location_facility: Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282

location_facility: Fujian Medical University Union Hospital /ID# 215555

location_facility: Guangdong Provincial People's Hospital /ID# 218666

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214244

title: A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Germany
Italy
Hungary
Israel
United Kingdom
Australia
Brazil
Japan
Switzerland
United States
China
Korea, Republic of
Spain
Greece
Taiwan
Czechia
Canada
France


study_start_date_type: Actual

acronym: MANDARA

intervention_type: Biological

lead_sponsor: AstraZeneca

summary:
This is a randomized, double blind, active-controlled, parallel group, multicenter 52-week Phase 3 study to compare the efficacy and safety of benralizumab 30 mg versus mepolizumab 300 mg administered by subcutaneous (SC) injection in patients with relapsing or refractory EGPA on corticosteroid therapy with or without stable immunosuppressive therapy.

All patients who complete the 52-week double-blind treatment period on IP may be eligible to continue into an open label extension (OLE) period. The OLE period is intended to allow each patient at least 1 year of treatment with open-label benralizumab 30 mg administered SC (earlier enrolled patients may therefore be in the OLE for longer than 1 year).

ReferenceType: derived

ReferenceCitation: Serling-Boyd N, Wallace ZS. Management of primary vasculitides with biologic and novel small molecule medications. Curr Opin Rheumatol. 2021 Jan;33(1):8-14. doi: 10.1097/BOR.0000000000000756.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

status: Active, not recruiting

title: A Randomized, Double-blind, Active-controlled 52-week Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Patients Receiving Standard of Care Therapy

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Germany
Italy
Israel
United Kingdom
Japan
Belgium
United States
Canada
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG

acronym: CheckMate 7G8

summary: A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Israel
Argentina
Australia
Brazil
Japan
Austria
Netherlands
Sweden
United States
Spain
Greece
Chile
Canada
Russian Federation
France

location_facility:
Local Institution - 0075
Local Institution - 0011
Local Institution - 0009
Local Institution - 0072
Local Institution - 0164
Local Institution - 0105
Local Institution - 0103
Local Institution - 0095
Local Institution - 0096
Local Institution - 0058
Local Institution - 0063
Local Institution - 0157
Local Institution - 0016
Local Institution - 0106
Local Institution - 0008
Local Institution - 0107
Local Institution
Local Institution - 0074
Local Institution - 0097
Local Institution - 0099
Local Institution - 0087
Local Institution - 0158
Local Institution - 0042
Local Institution - 0031
Local Institution - 0054
Local Institution - 0149
Local Institution - 0104
Local Institution - 0037
Local Institution - 0156
Local Institution - 0155
Local Institution - 0066
Local Institution - 0159
Local Institution - 0051
Local Institution - 0060
Local Institution - 0154
Local Institution - 0165
Local Institution - 0111
Local Institution - 0150
Local Institution - 0083
Local Institution - 0161
Local Institution - 0067
Local Institution - 0059
Local Institution - 0081
Local Institution - 0146
Local Institution - 0040
Local Institution - 0038
Local Institution - 0064
Local Institution - 0061
Local Institution - 0052
Local Institution - 0145
Local Institution - 0151
Local Institution - 0108
Local Institution - 0114
Local Institution - 0047
Local Institution - 0065
Local Institution - 0049
Local Institution - 0050
Local Institution - 0048
Local Institution - 0010
Local Institution - 0017
Local Institution - 0057
Local Institution - 0084
Local Institution - 0041
Local Institution - 0080
Local Institution - 0055
Local Institution - 0002
Local Institution - 0032
Local Institution - 0147
Local Institution - 0073
Local Institution - 0012
Local Institution - 0160
The University Of Chicago
Local Institution - 0062
Local Institution - 0001
Local Institution - 0153
Local Institution - 0094
Local Institution - 0045
Local Institution - 0162
Local Institution - 0093
Local Institution - 0098
Local Institution - 0088

intervention_type: Drug


lead_sponsor: Hoffmann-La Roche

summary: Study MO39874 is an open-label, Phase IIIb, single arm, global study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received chemotherapy for their unresectable locally advanced or metastatic disease.

location_facility: CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie

location_facility: Clinica Oncologica-Ospedali Riuniti Ancona

location_facility: USL Umbria 1 - Osp. Città di Castello; U.O. di Oncologia

location_facility: Bács-Kiskun Vármegyei Oktatókórház; Onkoradiológiai Központ

location_facility: Hospital Central Fap Juan Benavides Dorich; Oncology

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház; Klin. Onkológiai és Sugárterápiás Centrum

location_facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria ? Polo Oncologico

location_facility: Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

location_facility: Hôpital Franco-Britannique- Fondation Cognacq-Jay; Cancerologie

location_facility: Hospital Garcia de Orta; Servico de Oncologia Medica

location_facility: Fondazione IRCCS Policlinico San Matteo, Oncologia

location_facility: Hospital Universitario San Cecilio; Servicio de Oncologia

location_facility: Institut de Cancérologie de Bourgogne; Oncologie Médicale

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Komarom-Eszergom Varmegyei Szent Borbala Korhaz; Onkologiai Osztaly

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Hospital de S. Francisco Xavier; Unidade de Oncologia Medica

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Azienda ospedaliero-universitaria careggi, Sezione di radioterapia del dipartimento di fisiopatolo

location_facility: Univerzitetni klini?ni center Maribor; Oddelek za onkologijo

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Clinique Onco Des Dentellieres; Chimiotherapie Radiotherapie

location_facility: AULSS3 - Presidio di Mirano; Dip. di Oncologia

location_facility: Hospital Cuf Descobertas; Unidade de Oncologia

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

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Pontificia Universidad Catolica de Chile; Centro Del Cáncer

location_facility: Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol

location_facility: Presidio Ospedaliero di Summa-Perrino; Oncologia Medica

location_facility: Nemocnice na Bulovce; Ustav radiacni onkologie

location_facility: Hospital Nacional Cayetano Heredia; Hematology - Oncology

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

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Ospedale Della Misericordia; U.O. Di Medicina Ia - Oncologia Medica

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii

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

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Azienda Universitaria Magna Grecia; Dip. di Medicina Sperimentale e Clinica_U.O. Oncologia Medica

location_facility: Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

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

location_facility: Fondazione del Piemonte per l?Oncologia (IRCCS)

location_facility: Zala Vármegyei Szent Rafael Kórház; Onkológiai Osztály

title: An Open-Label, Phase IIIb, Single Arm, Multicenter Safety Study of Atezolizumab (Tecentriq) Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

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

location_country: Slovenia Italy Poland Portugal Hungary Argentina Romania Mexico Spain Chile Czechia Peru France


title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Mepolizumab 100 mg SC as add-on Treatment in Participants With COPD Experiencing Frequent Exacerbations and Characterized by Eosinophil Levels (Study 208657)

acronym: MATINEE

summary: This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

sponsor_collaborators: GlaxoSmithKline PPD

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Canada
France
Hungary
Denmark
United States
India
Belgium
China
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Israel


type: Other Identifier

title: A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations

summary:
Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D).

Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric subjects with advanced or metastatic malignancies harboring ALK, ROS1, or NTRK1-3 alterations.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Wachter F, Al-Ibraheemi A, Trissal MC, Hollowell M, DuBois SG, Collins NB, Church AJ, Janeway KA. Molecular Characterization of Inflammatory Tumors Facilitates Initiation of Effective Therapy. Pediatrics. 2021 Dec 1;148(6):e2021050990. doi: 10.1542/peds.2021-050990.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: American Academy of Pediatrics (AAP)

ipd_sharing: No

ipd_sharing_description: There are no plans to share individual participant data with other researchers.

lead_sponsor: Turning Point Therapeutics, Inc.

location_country:
Italy
Singapore
Denmark
Australia
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Washington University School of Medicine in St. Louis

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center.

location_facility: Children's Hospital Colorado - Anschutz Medical Campus


lead_sponsor: Taiho Oncology, Inc.

summary: This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of patients with advanced, metastatic, or recurrent unresectable iCCA harboring FGFR2 gene rearrangements

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: University College London Hospital NHS Foundation Trust

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: National Cheng Kung University Hospital NCKUH

location_facility: Chulabhorn Hospital, HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy

location_facility: Instituto Nacional de Cancer Jose Alencar Gomes da Silva - INCA

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

location_facility: Medical Oncology Associates, PS - Summit Cancer Centers

location_facility: The University of Hong Kong, Queen Mary Hospital

location_facility: Technische Universitaet Muenchen - Klinikum rechts der Isar

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Instituto Nacional de Enfermedades Neoplasicas (INEN)

location_facility: Instituto do Cancer do Estado de Sao Paulo

location_facility: Centro de Estudios y Prevencion del Cancer (CEPREC)

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Chi Mei Medical Center CMMC - Yongkang branch

location_facility: Fundacion Favaloro para la Docencia e Investigacion Medica

location_facility: Hospital de Gastroenterologia Dr. C. Bonorino Udaondo

location_facility: Institut de Cancerologie Strasbourg Europe ICAENS

location_facility: Hospital Universitario Virgen de la Arrixaca HUVA

location_facility: Hospital Universitario Jose Eleuterio Gonzalez

location_facility: Hopitaux Universitaires Paris Nord Val de Seine - Hopital Beaujon

location_facility: Fundacao Antonio Prudente - A.C.Camargo Cancer Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University

location_facility: The Chinese University of Hong Kong Prince of Wales Hospital

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Ospedale Maggiore della Carita di Novara

location_facility: Yonsei University Health System - Severance Hospital

location_facility: Khon Kaen University KKU - Faculty of Medicine-Srinagarind Hospital

location_facility: Szpital Kliniczny Przemienienia Pańskiego UM im. Karola Marcinkowskiego w Poznaniu

title: A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements FOENIX-CCA3

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
France
Portugal
Hong Kong
United States
Belgium
Peru
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan


type: Registry Identifier

title: Phase 1/2 Study of TAK-981 in Combination With Rituximab in Patients With Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma

summary:
This study is about a medicine called TAK-981 given with rituximab, used to treat adults with relapsed or refractory CD20-positive non-Hodgkin lymphoma.

This study has 2 parts.

The main aims of the study are:

To check for side effects from treatment with TAK-981 given with rituximab.
To check how much TAK-981 participants can tolerate.
To check if participants with diffuse large B-cell lymphoma or follicular lymphoma respond well to treatment.

Participants will receive TAK-981 and rituximab in 21-day cycles. They will continue treatment for about 12 months unless their condition gets worse (disease progression), they cannot tolerate the treatment, or they leave the study for certain reasons.

status: Terminated

study_completion_date_type: Actual

design_allocation: Non-Randomized

ReferenceCitation: Nakamura A, Grossman S, Song K, Xega K, Zhang Y, Cvet D, Berger A, Shapiro G, Huszar D. The SUMOylation inhibitor subasumstat potentiates rituximab activity by IFN1-dependent macrophage and NK cell stimulation. Blood. 2022 May 5;139(18):2770-2781. doi: 10.1182/blood.2021014267.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Hematology

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Germany
Italy
United Kingdom
Japan
United States
China
Spain
Canada
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: Beatson West of Scotland Cancer Centre - PPDS

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Complejo Asistencial Universitario de Salamanca H. Clinico

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Mayo Clinic - Cancer Center - Rochester - PPDS

location_facility: City of Hope - Comprehensive Cancer Center (CCC)

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Sir Mortimer B Davis Jewish General Hospital

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier de l'Universite de Montreal

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

location_facility: Ohio State University Wexner Medical Center

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: University of Michigan Comprehensive Cancer Center

status_simplified: Unknown


lead_sponsor: Vertex Pharmaceuticals Incorporated

summary: This study will evaluate the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes).

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.

publisher_dissemination: Wiley

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Charite Paediatric Pulmonology Department

location_facility: Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie

location_facility: University of California San Francisco, Lung Transplant Program

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: Papworth Hospital NHS Foundation Trust, Papworth Everard

location_facility: Clinical Research Facility, Queen Elizabeth University Hospital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: The University of Texas Southwestern Medical Center

location_facility: Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

location_facility: University of California Davis Medical Center

location_facility: Washington University School of Medicine / St. Louis Children's Hospital

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

location_facility: University of Miami Miller School of Medicine

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center

location_facility: Justus-Liebig-Universitaet Gießen Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Banner University of Arizona Medical Center

location_facility: Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

location_facility: Azienda Ospedaliero Universitaria Ospedale Riuniti

location_facility: Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Miller Children's Hospital / Long Beach Memorial

location_facility: University of Utah / Primary Children's Medical Center

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

location_facility: CHU de Montpellier - Hopital Arnaud de Villeneuve

status: Completed

title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing.

location_country:
Germany
Ireland
Italy
United Kingdom
Denmark
Australia
Netherlands
Belgium
United States
Spain
Canada
France

status_simplified: Completed


summary: This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).

ReferenceCitation: Barry PJ, Mall MA, Alvarez A, Colombo C, de Winter-de Groot KM, Fajac I, McBennett KA, McKone EF, Ramsey BW, Sutharsan S, Taylor-Cousar JL, Tullis E, Ahluwalia N, Jun LS, Moskowitz SM, Prieto-Centurion V, Tian S, Waltz D, Xuan F, Zhang Y, Rowe SM, Polineni D; VX18-445-104 Study Group. Triple Therapy for Cystic Fibrosis Phe508del-Gating and -Residual Function Genotypes. N Engl J Med. 2021 Aug 26;385(9):815-825. doi: 10.1056/NEJMoa2100665.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

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

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

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

version: submittedVersion

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

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

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

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Charite Paediatric Pulmonology Department

location_facility: Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie

location_facility: University of California San Francisco, Lung Transplant Program

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: Malattie Apparato Respiratorio 2 - Fibrosi Cistica

location_facility: Papworth Hospital NHS Foundation Trust, Papworth Everard

location_facility: Clinical Research Facility, Queen Elizabeth University Hospital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: The University of Texas Southwestern Medical Center

location_facility: Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

location_facility: University of California Davis Medical Center

location_facility: Washington University School of Medicine / St. Louis Children's Hospital

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

location_facility: University of Miami Miller School of Medicine

location_facility: Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital

location_facility: The University of Iowa Hospitals and Clinics

location_facility: Northwell Health- Long Island Jewish Medical Center

title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing

location_country:
Germany
Ireland
Italy
Israel
United Kingdom
Denmark
Australia
Netherlands
Belgium
United States
Spain
Canada
France


lead_sponsor: ADC Therapeutics S.A.

summary: The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).

location_facility: Cleveland Clinic - Taussig Cancer Center

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

location_facility: UCSF Health - Hematology and Blood and Marrow Transplant Clinic

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Washington University School of Medicine in Saint Louis

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Norton Cancer Institute - Saint Matthews

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

location_facility: University Hospitals Seidman Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Memorial Sloan-Kettering Cancer Center - New York

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clínico

title: A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Belgium
United States
Spain
Czechia
Canada
France


title: A Follow-up Phase 2a Open-label Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 in Patients With Moderate to Severe Active Rheumatoid Arthritis

summary: A phase 2a open-label study to evaluate the long-term safety and efficacy of ABX464 50mg as maintenance therapy in patients with moderate to severe rheumatoid arthritis.

ipd_sharing: Undecided

lead_sponsor: Abivax S.A.

location_country: Poland Hungary Belgium Czechia France

location_facility: CMed Rehabilitációs és Diagnosztikai Központ


lead_sponsor: ViiV Healthcare

summary: The aim of this study is to determine if virologically suppressed Human Immunodeficiency Virus (HIV) Type 1 infected adults on a current antiretroviral regimen (CAR) (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC). The main objective of the study is to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks in virologically suppressed adults living with HIV-1. The study will also evaluate information regarding the safety and health related quality of life. The study will include Screening Phase (up to 28 days), a Randomization Phase (up to Week 52) and a Continuation Phase (post Week 52). The Continuation Phase is not applicable for participants in Sweden and Denmark. Approximately 490 participants will be randomized in 1:1 ratio to receive DTG/3TC FDC once daily for up to 52 weeks or continue their CAR for 52 weeks. Participants in the DTG/3TC FDC arm who successfully complete up to 52 weeks of treatment will have the opportunity to continue receiving DTG/3TC FDC once daily in Continuation Phase.

ReferenceType: background

ReferenceCitation: Llibre JM, Brites C, Cheng CY, Osiyemi O, Galera C, Hocqueloux L, Maggiolo F, Degen O, Taylor S, Blair E, Man C, Wynne B, Oyee J, Underwood M, Curtis L, Bontempo G, van Wyk J. Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With Human Immunodeficiency Virus 1 (HIV-1): Week 48 Results From the Phase 3, Noninferiority SALSA Randomized Trial. Clin Infect Dis. 2023 Feb 18;76(4):720-729. doi: 10.1093/cid/ciac130.

ReferenceCitation: Masters MC, Cohn SE. Two-drug HIV regimens: more data still needed. Lancet HIV. 2021 Aug;8(8):e454-e455. doi: 10.1016/S2352-3018(21)00106-5. No abstract available.

publisher_dissemination: Elsevier

sponsor_collaborators:
ViiV Healthcare
GlaxoSmithKline
PPD

title: A Phase III, Randomized, Multicenter, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine Fixed Dose Combination in HIV-1 Infected Adults Who Are Virologically Suppressed

location_country:
Germany
Italy
United Kingdom
Argentina
Denmark
Brazil
Sweden
Mexico
Belgium
United States
China
Spain
South Africa
Taiwan
Canada
Russian Federation
France

collaborators: GlaxoSmithKline PPD


summary: Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)

title: A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Poland
Argentina
Japan
Brazil
Thailand
Vietnam
Turkey
Czechia
Canada
France
Colombia
Portugal
Slovakia
Hungary
United States
India
China
Malaysia
Peru
Philippines
United Kingdom
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
South Africa
Taiwan
Russian Federation
Sweden


acronym: MabCute

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

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

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Trieste https://www.units.it/ - ArTS Archivio della ricerca di Trieste

repository_institution: University of Plymouth - PEARL

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Theodore-Oklota C, Humphrey L, Wiesner C, Schnetzler G, Hudgens S, Campbell A. Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to subcutaneous administration of rituximab. Patient Prefer Adherence. 2016 Sep 13;10:1767-1776. doi: 10.2147/PPA.S108489. eCollection 2016.

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Informa

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

evidence: open (via free pdf)

location_facility: Centro de Tratamento Oncologico - CETRON

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

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

location_facility: University College London, Department of Haematology

location_facility: University Hospital of Ioannina; Hematology

location_facility: Rus Med Academy for Postgraduate Education; Oncology Department

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

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

location_facility: Spitalul Clinic Coltea; Clinica de Hematologie

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

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

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

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

location_facility: Royal Marsden Hospital; Dept. of Medicine

location_facility: Hopital Andre Mignot; Hematologie - Oncologie

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

location_facility: Hôpital Lapeyronie; Hématologie Oncologie Médicale

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

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

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

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

location_facility: Centre Hospitalier de La Cote Basque; Hematologie

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

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

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

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

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

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

location_facility: Ospedale Ferrarotto; Divisione Di Ematologia

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

location_facility: Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie

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

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

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

location_facility: Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia

location_facility: Kent & Canterbury Hospital; Clinical Haematology

location_facility: CH Henri Mondor; Med Interne Neuro Endocrinologie

location_facility: Semmelweis University, First Dept of Medicine

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

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

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

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

location_facility: Hospital Royo Villanova; Servicio de Hematologia

location_facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia

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

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

location_facility: University Hospital of Larissa; Hematology Dept.

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

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

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

location_facility: Södersjukhuset, Medicinkliniken/Sektionen för Hematologi

location_facility: National Oncology Inst. ; Dept. of Haematology

location_facility: Hacettepe Uni Medical Faculty; Hematology

location_facility: Hospital Duran i Reynals; Servicio de Hematologia

location_facility: The Royal Marsden Hospital; Dept of Medicine

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Norfolk & Norwich Hospital; Dept of Haematology

location_facility: County Clinical Emergency Hospital Brasov

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

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

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

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

location_facility: Centre Antoine Lacassagne;B4 Hematologie Cancerologie

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

location_facility: Leicester Royal Infirmary; Dept of Haematology

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

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

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

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

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

location_facility: Kasr Eieny Uni Hospital; Oncology (Nemrock)

location_facility: Hôpital Albert Michallon; Hematologie Clinique

location_facility: Hospital Quiron de Madrid; Servicio de Hematologia

location_facility: Hospital Universitario San Cecilio; Servicio de Oncologia

location_facility: Birmingham Heartlands Hospital; Department of Haematology

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: General Hospital of Athens Evangelismos; Hematology

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

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: Royal Bournemouth General Hospital; Haematology

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

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

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

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

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: St. Olavs Hospital HF, Kreftavdelingen, Gastrosentret

location_facility: Uni Hospital of Wales; Dept of Haematology

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

location_facility: Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel

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

location_facility: Ospedale Cardarelli; Divisione Di Ematologia

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

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

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

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

location_facility: Hopital Pitie Salpetriere; Hematologie Clinique

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

location_facility: Instituto Nacional de Cancerologia; Hematology

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

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

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

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

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

location_facility: Teodoro Maldonado Carbo Hospital; Oncology Service

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

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

location_facility: Hospital San Pedro De Alcantara; Servicio de Hematologia

location_facility: Hospital das Clinicas - FMUSP; Hematologia

location_facility: Ch Sud Francilien; Hematologie Oncologie

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

location_facility: Royal Liverpool Uni Hospital; Haematology

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

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

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

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

location_facility: Tokuda Hospital Sofia; Hematology department

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

location_facility: Dres. Emil Höring Matthias Respondek und Ulrike Schwinger

location_facility: Hospital Universitario de Canarias;servicio de Hematologia

location_facility: Västmanlands sjukhus Västerås, Onkologmottagningen

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

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


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

acronym: Monitor-GCSF

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

study_type: Observational

time_perspective: Prospective

lead_sponsor: Sandoz

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


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

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

location_country: Macedonia, The Former Yugoslav Republic of


title: Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes

acronym: SOUL

summary: The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Argentina
Algeria
Japan
Brazil
Thailand
Turkey
Croatia
Czechia
Canada
Serbia
France
Colombia
Slovakia
Hong Kong
Denmark
United States
Ukraine
India
Romania
Belgium
China
Malaysia
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


title: A Phase 1, First-in-Human, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-67856633, an Inhibitor of MALT1, in Participants With NHL and CLL

summary: The purpose of this study is to determine the recommended Phase 2 dose regimen or the maximum tolerated dose of JNJ-67856633 in participants with relapsed/ refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia.

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Japan
United States
China
Korea, Republic of
Spain
Greece
France

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science

location_facility: Tianjin Medical University Cancer Institute and Hospital


title: A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

summary: An observational study to evaluate the natural progression of dry AMD in genetically defined subjects

lead_sponsor: Gyroscope Therapeutics Limited

sponsor_collaborators:
Gyroscope Therapeutics Limited
Novartis Pharmaceuticals

location_country:
Germany
Poland
United Kingdom
Australia
Netherlands
United States
Spain
France

location_facility: Johns Hopkins University School of Medicine

location_facility: Retinal Research Institute (retina consultants of AZ)

location_facility: University Hospital Schleswig-Holstein - Campus Luebeck

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Oftalmika - Prywatna Klinika Okulistyczna

location_facility: Proliance Retina (formally known as Vitreoretinal Associates of Washington)

location_facility: Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu

location_facility: Clinica Universidad de Navarra - Pamplona

location_facility: Retina Vitreous Associates Medical Group

location_facility: Specjalistyczny Osrodek Okulistyczny Oculomedica

location_facility: Wake Forest Baptist Medical Center - Wake Forest University School of Medicine

location_facility: Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital

location_facility: Hospital General de Catalunya Sant Cugat del Valles

location_facility: The University of Melbourne - The Centre for Eye Research Australia (CERA)

location_facility: Klinikum rechts der Isar der Technische Universitaet Muenchen


title: An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

summary:
Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups:

In patients with follicular lymphoma (FL) grade 1-3a *1,2
In patients with diffuse large B-cell lymphoma (DLBCL) *1,2
In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy.
In patients with marginal zone lymphoma (MZL) *1
In patients with other B-NHL subtypes *1

Secondary objectives are:

To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by:
ORR according to the Lugano Classification and as assessed by local investigator evaluation
Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review
Progression-free survival (PFS)*3
Overall survival (OS)
Duration of response (DOR)*3
Disease control rate (DCR)*3
To evaluate the safety and tolerability of odronextamab
To assess the pharmacokinetics (PK) of odronextamab
To assess the immunogenicity of odronextamab

To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L)

1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy
2 including an anti-CD20 antibody and an alkylating agent
3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Germany
Italy
Poland
United Kingdom
Singapore
Australia
Japan
United States
China
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Klinikum Chemnitz gGmbH Klinik fuer Innere Medizin III

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Taipei Medical University - Shuang-Ho Hospital

location_facility: Klinik fur Innere Medizin II Schwarzwald Baar Klinikum

location_facility: Kobe City Medical Center General Hospital

location_facility: The First Affiliated Hospital of Soochow University

location_facility: John Theurer Cancer Center Hackensack University Medical Center

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

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Hospital Universitario Quiron Salud Madrid

location_facility: Keimyung University Dongsan Medical Center

location_facility: Border Medical Oncology, Albury Wodonga Regional Cancer Centre

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Koo Foundation Sun Yat Sen Cancer Center

location_facility: SC Ematologia Dip to Oncologico e Tecnologie Avanzate_ IRCCS - Arcispedale Santa Maria Nuova

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

location_facility: University/Academic Hospital Mayo Clinic

location_facility: Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: The First Bethune Hospital Of Jilin University

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Saitama Medical University International Medical Center

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico

location_facility: " University Hospital Kyoto Prefectural University of Medicine"

location_facility: Apteka IHiT (Instytut Hematologii I Transfuzjologii

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

location_facility: Second Affiliated Hospital of Army Medical University, PLA

location_facility: The First Affiliated Hospital of Xi 'an Jiaotong University

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

location_facility: Harbin Medical University Cancer Hospital

location_facility: Centre Hospitalier Universitaire (CHU) de Poitiers

location_facility: Sun Yat-Sen University Cancer Center (Cancer Prevention and Treatment Center, Sun Yat-sen University)

location_facility: National Hospital Organization National Kyushu Cancer Center

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research)

location_facility: West China Hospital of Sichuan University

location_facility: Struttura Complessa di Ematologia e Trapianto di cellule staminali emopoietiche _ IRCCS Casa Sollievo della Sofferenza

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Penninsula & South Eastern Haemotology and Oncology Group


acronym: Clarity AD

lead_sponsor: Eisai Inc.

summary: This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.

sponsor_collaborators:
Eisai Inc.
Biogen

location_facility: Severance Hospital, Yonsei University Health System

location_facility: National Clinical Research Inc.-Richmond

location_facility: HammondCare Malvern Clinical Trials Unit

location_facility: Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais

location_facility: University of Kansas Medical Center Research Institute

location_facility: Clinica Neurologica, IRCCS Ospedale Policlinico San Martino, Genova

location_facility: Australian Alzheimer's Research Foundation

location_facility: Prima Clinica Neurologica, Primo Policlinico AOU "L. Vanvitelli"

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Xiangya Hospital Central South University

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: MoCA Clinic and Institute/NeuroSearch Developpements Inc.

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Universita' Sapienza di Roma - Dipartimento di Neuroscienze Umane

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Alliance for Multispecialty Research LLC, New Orleans Center for Clinical Research / Volunteer Research Group, an AMR company

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Alzheimer's Research and Treatment Center

location_facility: Memory Assessment & Research Centre (MARC),

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Emory University Cognitive Neurology Clinic & ADRC

location_facility: North Bay Neuroscience Research Institute

location_facility: The Second Hospital of Hebei Medical University

location_facility: Sun Yat-Sent Memorial Hospital of Sun Yat-Sen University

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - U.O.S.D. Malattie Neurodegenerative

location_facility: Raleigh Neurology Associates, P.A. - Research Department

location_facility: Ospedale S. Maria della Misericordia, S. Andrea delle Fratte

location_facility: Allied Biomedical Research (Clinical Trial)

location_facility: Banner Alzheimer's Institute- Clinical Trials Department

location_facility: Advanced Memory Research Institute of NJ, PC

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

location_facility: Central Adelaide Local Health Network, The Queen Elizabeth Hospital and the Royal Adelaide Hospital

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: Butler Hospital - Memory and Aging Program

location_facility: ANI Neurology, PLLC d/b/a Alzheimer's Memory Center

location_facility: True North Clinical Research Kentville, Inc.

location_facility: Neuropsychiatric Research Center of Southwest FL

location_facility: The Prince Charles Hospital/Internal Medicine & Dementia Research Unit

location_facility: The First Bethune Hospital of Jilin University

location_facility: Neurological Associates of Tucson dba Center for Neurosciences

location_facility: Memory Clinic, Malmö University Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Institute for Neurodegenerative Disorders

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Baylor College of Medicine AD and Memory Disorders Center

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Centre de Recherche Clinique du Gérontopôle

location_facility: New York University Medical Center PRIME

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Fondazione Policlinico Agostino Gemelli - UCSC

location_facility: True North Clinical Research Halifax, Inc.

location_facility: Associated Neurologists of Southern Connecticut

location_facility: Austin Health - Medical and Cognitive Research Unit

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

location_facility: Renji Hospital Shanghai Jiaotong Universtiy School of Medicine

location_facility: Nanjing Brain Hospital, Affiliated to Nanjing Medical University

location_facility: St Vincent's Hospital - Translational Research Centre

location_facility: Seoul National University Boramae Medical Center

location_facility: Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory Clinic

title: A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

location_country:
Germany
Italy
United Kingdom
Singapore
Australia
Japan
Sweden
United States
China
Korea, Republic of
Spain
Canada
Russian Federation
France


lead_sponsor: Centre Hospitalier Universitaire Dijon

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

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

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

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

repository_institution: University of Liège - Open Repository and Bibliography

publisher_dissemination: American Society of Clinical Oncology (ASCO)

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

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

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

repositories_concat: HAL

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

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

sponsor_collaborators:
Centre Hospitalier Universitaire Dijon
The Lymphoma Study Association

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Hopitaux Civil de Colmar - Hopital Pasteur

location_facility: CHU Haut Leveque - Centre François Magendie

location_facility: Institut Curie - Hopital Claudius Régaud

location_facility: CHU de Strasbourg-Hopital de Hautepierre

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

location_country: Belgium France

lead_sponsor_type: academique


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

acronym: ATLANTIC

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

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

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

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

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

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

ReferenceType: result

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

license: public-domain

license_normalized: public-domain

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

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

publisher_dissemination: Springer-Nature

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

repositories_institution: University of Trieste https://www.units.it/ - ArTS Archivio della ricerca di Trieste

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

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

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

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_institution: Linkoping University - DiVA

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

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

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

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

ReferenceCitation: Montalescot G, van 't Hof AW, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Collet JP, Goodman SG, Hammett CJ, Huber K, Janzon M, Lapostolle F, Lassen JF, Licour M, Merkely B, Salhi N, Silvain J, Storey RF, Ten Berg JM, Tsatsaris A, Zeymer U, Vicaut E, Hamm CW; ATLANTIC Investigators. Effect of Pre-Hospital Ticagrelor During the First 24 h After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction: The ATLANTIC-H(2)(4) Analysis. JACC Cardiovasc Interv. 2016 Apr 11;9(7):646-56. doi: 10.1016/j.jcin.2015.12.024. Epub 2016 Mar 5.

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

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

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Italy
Hungary
United Kingdom
Algeria
Australia
Denmark
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Austria
Sweden
Spain
Canada
France


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

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

primary_purpose: Supportive Care

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

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

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

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

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

lead_sponsor: Amgen

sponsor_collaborators:
Amgen
Daiichi Sankyo, Inc.

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