acronym: PROTECT

lead_sponsor: Provention Bio, Inc.

summary:
The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks..

Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.

location_facility: Benaroya Research Institute at Virginia Mason (Site 016)

location_facility: Hopitaux Pediatriques de Nice CHU-Lenval service de diabetologie et d'endocrinologia (Site 508)

location_facility: AM Diabetes & Endocrinology Center (Site 008)

location_facility: Washington University School of Medicine (Site 018)

location_facility: Childrens Hospital of Philadelphia - Endocrinology (Site 021)

location_facility: Universitatsklinikum Carl Gustav Carus (Site 601)

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház ( Site 705)

location_facility: Children's Medical Center Dallas (Site 033)

location_facility: Centre Hospitalier Regional (CHR) d'Orleans-Service de pediatrie (Site 513)

location_facility: Universitätsklinikum Freiburg (Site 603)

location_facility: Northwick Park Hospital - Paediatrics (site 904)

location_facility: Endocrinology Service Northwest, LLC (Site 034)

location_facility: Uniwersyteckie Centrum Kliniczne (Site 803)

location_facility: Indiana University Hospital and Riley Hospital for Children (Site 014)

location_facility: Baystate Pediatric Endocrinology & Diabetes (Site 040)

location_facility: Universitätsklinikum Heidelberg (Site 608)

location_facility: Evangelisches Klinikum Bethel Kinderklinik (Site 602)

location_facility: Rady Children's Hospital-San Diego (Site 004)

location_facility: Cardiff and Vale NHS Trust - University Hospital of Wales (Site 902)

location_facility: Vanderbilt University Medical Center (Site 024)

location_facility: University of Chicago Medical Center (Site 017)

location_facility: U. Minnesota Health Clinical Research Unit (Site 031)

location_facility: Children's Mercy Hospitals & Clinics (Site 026)

location_facility: Alberta Diabetes Institute Clinical Research Unit Li Ka Shing Centre for Health Research Innovation (Site 103)

location_facility: CHU Hopital de la Timone-Hopital d'Enfants (Site 512)

location_facility: Sanford Diabetes and Thyroiid Clinical (Site 013)

location_facility: Kinderkrankenhaus Auf Der Bult (Site 604)

location_facility: Diablo Clinical Research, Inc. (Site 002)

location_facility: Groupe hospitalier Est-Hopital Femme, Mere, Enfant (Site 509)

location_facility: Groupe Hospitalier Necker Enfants Malades (site 502)

location_facility: Nemours Children's Specialty Care-Endocrinology (Site 047)

location_facility: Sheffield Children's NHS Foundation Trust Western Bank (Site 903)

location_facility: All Children's Hospital-Johns Hopkins Medicine (Site 048)

location_facility: Capital Diabetes & Endocrine Associates (Site 029)

location_facility: Rocky Mountain Diabetes and Osteoporosis Center (Site 007)

location_facility: MultiCare Institute for Research & Innovation (Site 003)

location_facility: CHU UCL Namur, site Clinique Sainte-Elisabeth (Site 205)

location_facility: St. Luke's Children's Endocrinology (Site 052)

location_facility: Montreal Children's Hospital-McGill (Site 101)

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu (Site 804)

location_facility: University of South Florida Diabetes and Endocrinology Center (Site 011)

location_facility: UF Clinical and Translation Research Building (Site 015)

location_facility: University of Colorado-Barbara Davis Center for Childhood Diabetes (Site 005)

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka" (Site 801)

location_facility: Universitätsklinikum Augsburg (Site 606)

location_facility: Women and Children's Hospital of Buffalo (Site 010)

location_facility: Rainbow Babies & Children's Hospital (Site 049)

location_facility: Instytut Diabetologii Sp. z o.o. (Site 802)

location_facility: UNC Hospitals Children's Specialty Clinic (Site 038)

location_facility: University of Miami Health System (Site 028)

title: Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized FcR Non-Binding Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

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


study_start_date_type: Actual

acronym: iNTEGRATE

intervention_type: Drug

lead_sponsor: Pharmacyclics LLC.

summary: To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

sponsor_collaborators:
Pharmacyclics LLC.
Janssen Research & Development, LLC

location_facility: Krankenhaus der Elisabethinen Linz /ID# 1140-0849

location_facility: Kyungpook National Univ Hosp /ID# 1140-1153

location_facility: Mayo Clinic, Rochester, MN /ID# 1140-0240

location_facility: Universitatsklinikum Munster /ID# 1140-1195

location_facility: SoonChunHyang University Seoul /ID# 1140-1163

location_facility: Duplicate_University of Tsukuba Hospital /ID# 1140-1445

location_facility: Rutgers Cancer Institute of NJ /ID# 1140-0803

location_facility: University of Rochester Cancer Center /ID# 1140-0127

location_facility: University of Louisville Hospital /ID# 1140-1131

location_facility: Florida Hospital Cancer Institute/Adventist Health System/Sunbelt, Inc /ID# 1140-1121

location_facility: Yonsei University Health System, Severance Hospital /ID# 1140-0927

location_facility: Okayama University Hospital /ID# 1140-1430

location_facility: Dup_Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 1140-1439

location_facility: Stanford University/Stanford Cancer Center, Pasteur Drive /ID# 1140-0400

location_facility: Jackson Memorial Hospital, University of Miami /ID# 1140-0647

location_facility: CHU Amiens Groupe hospitalier Sud /ID# 1140-1205

location_facility: Kobe City Medical Center General Hospital /ID# 1140-1438

location_facility: University Hospital of Regensburg /ID# 1140-1446

location_facility: Emory University/Winship Cancer Institute /ID# 1140-1179

location_facility: China Medical University Hosp /ID# 1140-1199

location_facility: Stony Brook University Medical Center /ID# 1140-0719

location_facility: Hospital Universitario Virgen del Rocio /ID# 1140-0863

location_facility: Centro Trapianti Cellule Staminali, Ospedale Infantile Regina Margherita /ID# 1140-1156

location_facility: A.O. Univ. Ospedali Riuniti /ID# 1140-0932

location_facility: Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 1140-1437

location_facility: The Ottawa Hospital Regional Cancer Center /ID# 1140-0159

location_facility: Boston Childrens Hospital /ID# 1140-1615

location_facility: Hackensack University Medical Center/ John Theurer Cancer Center /ID# 1140-0343

location_facility: Montefiore Medical Center - Moses Campus /ID# 1140-0120

location_facility: Osaka Women's and Children's Hospital /ID# 1140-1440

location_facility: Tokai University Hospital /ID# 1140-1444

location_facility: Dr. Haunerschen Kinderspital /ID# 1140-1142

location_facility: Singapore General Hospital /ID# 1140-1162

location_facility: National University Cancer Institute - National University Health System /ID# 1140-1155

location_facility: Chinese PLA General Hospital /ID# 1140-1198

location_facility: Hospital Santa Creu i Sant Pau /ID# 1140-0535

location_facility: Hopital Saint-Louis - Institut Hematologie Centre Hayem CHU /ID# 1140-0735

location_facility: New York Presbyterian Hospital/Weill Cornell Med College /ID# 1140-0200

location_facility: Duplicate_Kurashiki Central Hospital /ID# 1140-1442

location_facility: Osaka City University Hospital /ID# 1140-1157

location_facility: Ospedale San Raffaele IRCCS /ID# 1140-0523

location_facility: UCHSC Anschultz Cancer Pavilion /ID# 1140-0068

location_facility: Royal Brisbane and Women's Hospital /ID# 1140-0190

location_facility: Medical University of South Carolina, MUSC /ID# 1140-0738

location_facility: Emory University, Winship Cancer Institute /ID# 1140-0033

location_facility: University of North Carolina - Lineberger Comprehensive Cancer Center /ID# 1140-1133

location_facility: National Center for Child Health and Development /ID# 1140-1443

location_facility: Hospital Clinico Universitario de Valencia /ID# 1140-1145

location_facility: Weill Cornell Physicians - Hematologic Malignancies & Bone Marrow Transplant /ID# 1140-0019

location_facility: Princess Margaret Cancer Centre /ID# 1140-0043

location_facility: Centre Hospitalier Regional Universitaire de Lille /ID# 1140-0750

location_facility: Univ. Klinik for Innere Medizin, Klinische Abteilung for Hematologie, Graz /ID# 1140-0373

location_facility: Massachusetts General Hospital Cancer Center /ID# 1140-0020

location_facility: Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 1140-1120

location_facility: Children's National Medical Center /ID# 1140-1122

location_facility: Vanderbilt University Medical Center Vanderbilt Ingram Cancer Center /ID# 1140-0024

location_facility: Universitaetsklinikum Dresden /ID# 1140-1367

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu /ID# 1140-1150

location_facility: Groupe Hospitalier Pitie-Salpetriere /ID# 1140-0918

location_facility: Columbia University Medical Center, MS-CHONY /ID# 1140-1124

location_facility: Indiana University Melvin and Bren Simon Cancer Center /ID# 1140-0010

location_facility: Fred Hutchinson Cancer Research Center /ID# 1140-0404

location_facility: The Kinghorn Cancer Centre /ID# 1140-1165

location_facility: Royal Melbourne Hospital (RMH) /ID# 1140-0633

location_facility: National Taiwan Univ Hosp /ID# 1140-1184

location_facility: University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1140-0050

location_facility: Cath Univ Seoul St Mary's Hosp /ID# 1140-0928

location_facility: Hokkaido University Hospital /ID# 1140-1436

location_facility: Dana-Farber Cancer Institute /ID# 1140-0349

location_facility: Barbara Ann Karmanos Cancer In /ID# 1140-0130

location_facility: University of British Columbia (UBC) - Vancouver General Hospital (VGH) /ID# 1140-1166

location_facility: The First Affiliated Hospital of Soochow University /ID# 1140-1208

location_facility: Hyogo College of Medicine College Hospital /Id# 1140-1434

status: Completed

title: A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)

primary_purpose: Treatment

source: euctr

enrollment_type: Actual

ipd_sharing_description: Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
Hungary
Singapore
Australia
Japan
Austria
United States
China
Korea, Republic of
Spain
Croatia
Taiwan
Canada
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Relapsed/Refractory Marginal Zone Lymphoma

summary: Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).

ReferenceType: derived

ReferenceCitation: Noy A, de Vos S, Coleman M, Martin P, Flowers CR, Thieblemont C, Morschhauser F, Collins GP, Ma S, Peles S, Smith SD, Barrientos JC, Chong E, Wu S, Cheung LW, Kwei K, Hauns B, Arango-Hisijara I, Chen R. Durable ibrutinib responses in relapsed/refractory marginal zone lymphoma: long-term follow-up and biomarker analysis. Blood Adv. 2020 Nov 24;4(22):5773-5784. doi: 10.1182/bloodadvances.2020003121.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via observed oa rate)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: American Society of Hematology

ReferenceCitation: Noy A, de Vos S, Thieblemont C, Martin P, Flowers CR, Morschhauser F, Collins GP, Ma S, Coleman M, Peles S, Smith S, Barrientos JC, Smith A, Munneke B, Dimery I, Beaupre DM, Chen R. Targeting Bruton tyrosine kinase with ibrutinib in relapsed/refractory marginal zone lymphoma. Blood. 2017 Apr 20;129(16):2224-2232. doi: 10.1182/blood-2016-10-747345. Epub 2017 Feb 6.

oa_colors: green other

evidence: open (via free article)

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

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: bronze

location_country:
Germany
United Kingdom
Belgium
United States
France

location_facility:
Site Reference ID/Investigator# 750
Site Reference ID/Investigator# 195
Site Reference ID/Investigator# 377
Site Reference ID/Investigator# 033
Site Reference ID/Investigator# 370
Site Reference ID/Investigator# 837
Site Reference ID/Investigator# 348
Site Reference ID/Investigator# 350
Site Reference ID/Investigator# 142
Site Reference ID/Investigator# 560
Site Reference ID/Investigator# 047
Site Reference ID/Investigator# 735
Site Reference ID/Investigator# 763
Site Reference ID/Investigator# 745
Site Reference ID/Investigator# 030
Site Reference ID/Investigator# 220
Site Reference ID/Investigator# 814
Site Reference ID/Investigator# 736
Site Reference ID/Investigator# 749
Site Reference ID/Investigator# 669
Site Reference ID/Investigator# 737
Site Reference ID/Investigator # 200
Site Reference ID/Investigator # 407
Site Reference ID/Investigator# 742
Site Reference ID/Investigator# 368


lead_sponsor: Takeda

summary:
The main aim is to see if TAK-018 reduces the recurrence of intestinal inflammation after abdominal resection surgery in adults with Crohn's disease.

Participants will take either TAK-018 or placebo tablets by mouth, 2 times each day for up to 26 weeks after surgery. The placebo looks like TAK-018 but will not have any medicine in it.

Participants will have 6 study visits while receiving treatment. Visits 1 and 6 will be conducted at the study clinic. The others can be in the clinic or at the participant's home. Follow-up will occur 4 weeks after final treatment.

sponsor_collaborators: Takeda Development Center Americas, Inc.

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: University of Colorado Hospital Anschutz Cancer Pavilion

location_facility: NYU Langone Inflammatory Bowel Disease Center

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: University of Miami Leonard M. Miller School of Medicine

location_facility: University of North Carolina School of Medicine

location_facility: University of Arkansas for Medical Sciences

location_facility: Les Hopitaux Universitaires de Strasbourg - Hopital Hautepierre

location_facility: Columbia University Irving Medical Center

location_facility: Saint Helens and Knowsley Teaching Hospitals NHS Trust

location_facility: The University of Chicago Medical Center

location_facility: Vanderbilt Inflammatory Bowel Disease Clinic

location_facility: Centre Hospitalier Universitaire de Nice Hopital l'Archet

location_facility: University of Kentucky Chandler Medical Center

status: Terminated

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn's Disease Recurrence

primary_purpose: Prevention

type: EudraCT Number

type: Registry Identifier

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

location_country:
Germany
United Kingdom
Austria
United States
France

status_simplified: Unknown


title: TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line Has an Immune Checkpoint Inhibitor

summary: This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Yang Y, Psutka SP, Parikh AB, Li M, Collier K, Miah A, Mori SV, Hinkley M, Tykodi SS, Hall E, Thompson JA, Yin M. Combining immune checkpoint inhibition plus tyrosine kinase inhibition as first and subsequent treatments for metastatic renal cell carcinoma. Cancer Med. 2022 Aug;11(16):3106-3114. doi: 10.1002/cam4.4679. Epub 2022 Mar 18.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

lead_sponsor: AVEO Pharmaceuticals, Inc.

collaborators:
Parexel
Bristol-Myers Squibb

sponsor_collaborators:
AVEO Pharmaceuticals, Inc.
Parexel
Bristol-Myers Squibb

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Argentina
Australia
Brazil
Mexico
Belgium
United States
Spain
Chile
Czechia
Canada
France

location_facility: Oncology Hematology West PC dba Nebraska Cancer Specialists

location_facility: COPERNICUS Podmiot Leczn. Sp z o.o.,Wojew. Centrum Onkologii

location_facility: Saint Luke's Hospital - Saint Luke's Cancer Institute - Kans

location_facility: US Oncology Texas Oncology (CCC of South Texas) - San Antonio Medical Center

location_facility: ACEREY Centro de Investigación Clínica Oncológica

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Florida Cancer Specialists & Research Institute (FCS) - Tampa Cancer Center Location

location_facility: Institut Paoli Calmettes - HÃ´pital de jour

location_facility: Hospital Universitario Y Politécnico La Fe

location_facility: CHD Vendee La Roche sur Yon - Gastro-Entérologie

location_facility: University Of Washington - Medical Center

location_facility: Instituto Português Oncologia Francisco Gentil do Porto

location_facility: Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Texas Oncology - Central Austin Cancer Center

location_facility: John Hopkins Medicine - Hematology/oncology

location_facility: H. Santo Antonio. Centro Hospitalar do Porto

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Chattanooga Oncology and Hematology Associates

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych

location_facility: Liverpool Hospital Cancer Therapy Centre

location_facility: The Christie NHS Foundation Trust - Medical Oncology

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Sunnybrook Research Institute, sunnybrook Health Sciences Ct

location_facility: US Oncology - Rocky Mountain Cancer Centers - Midtown

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: Nzoz Mrukmed Lekarz Beata Madej-Mruk I Partner Sp. P.

location_facility: University of Maryland Medical Center-Greenebaum Cancer Ctr

location_facility: Memorial Sloan Kettering Cancer Center - Nassau

location_facility: Centre Leon Berard - departement d'oncologie medicale

location_facility: Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

location_facility: Centro para la Atención Integral del paciente Oncológico

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Kaiser Permanente Riverside Medical Center

location_facility: Instituto Brasileiro de Controle do Cancer - ibcc

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Gustave Roussy (Institut de Cancerologie Gustave-Roussy)

location_facility: Szpital Specjalistyczny im. L. Rydygiera w Krakowie

location_facility: Hopital Saint-Andre - Service d'Oncologie Medicale

location_facility: H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia

location_facility: Roswell - Roswell Park Cancer Institute - Medical Oncology

location_facility: University of New Mexico - Comprehensive Cancer Center

location_facility: Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital

location_facility: Memorial Sloan Kettering Cancer Center - Westchester

location_facility: CHU Michallon - Hopital Nord - Cancérologie Et Hématologie

location_facility: University of Kentucky UK Markey Cancer Center

location_facility: Institut Jules Bordet - Oncologie Médicale

location_facility: Hospital Particular do Algarve - Gambelas-Faro

location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

location_facility: ICO - Site Rene Gauducheau - Oncologie Medicale

location_facility: Institut de cancérologie de Strasbourg Europe - ICANS

location_facility: Inova Schar Cancer Institute - Medical Oncology

location_facility: Chao Family Comprehensive Cancer Center, UC Irvine

location_facility: Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie

location_facility: PO di Cremona, ASST di Cremona - Oncologia medica

status_simplified: Ongoing


title: Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma

summary:
The participants of this study would have relapsed/refractory follicular lymphoma.

Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after treatment and 'refractory' when treatment no longer works.

Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3.

Stage 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment.

status: Recruiting

ipd_sharing: No

lead_sponsor: Epizyme, Inc.

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Western Pennsylvania Hospital Hematology & Cellular Therapy

location_facility: Klinikum rechts der Isar der Technischen Universitat Muenche

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc.

location_facility: The Second Affiliated Hospital Zhejiang University School of Medicine

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.

location_facility: H Lee Moffitt Cancer Center and Research Institute I

location_facility: Willamette Valley Cancer Institute and Research Center - Oncology

location_facility: The Fourth Hospital of Hebei Medical University

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Florida Cancer Affiliates/Ocala Oncology - Clinic

location_facility: Centre Hospitalier Universitaire de Bordeaux-Hopital du Haut Leveque

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Semmelweis Egyetem Általános Orvostudományi Kar

location_facility: Hopital Henri Mondor - Hemopathies Lymphoides

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: St Bartholomew's Hospital Barts Health NHS Trust

location_facility: Fujian Medical University Union Hospital

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: Regional Cancer Care Associates-Freehold

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology

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

location_facility: Regional Cancer Care Associates LLC - Little Silver

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center

location_facility: The office of Frederick P. Smith, MD, P.C.

location_facility: Arizona Oncology Associates - Tuscon-Rusadill Road

location_facility: Yakima Valley Memorial Hospital - North Star Lodge Cancer Center

location_facility: UCLA Clinical Research Unit Hematology/Oncology

location_facility: The Affiliated Hospital of Guizhou Medical University

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: UT Health East Texas HOPE Cancer Center - Tyler

location_facility: Barwon Health, University Hospital Geelong

location_facility: Texas Oncology - Medical City Dallas Pediatric Hematology

location_facility: The First Bethune Hospital of Jilin University

location_facility: Huntsman Cancer Institute; The University of Utah

location_facility: St. Mary's Hospital and Regional Medical Center - St. Mary's

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Mass General Cancer Center at Newton-Wellesley

location_facility: The Affiliated Hospital of Qingdao University

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hackensack University Medical John Theurer Cancer Center

location_facility: Hematology Oncology Associates of Rockland, P.C.

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

location_facility: Rocky Mountain Cancer Centers (RMCC) - Boulder

location_facility: MC Rockwood Cancer Bl Specialty Ctr - North

location_facility: Regional Cancer Care Associates LLC - Howell

location_facility: University Health Network Princess Margaret Hospital

location_facility: Mayo Clinic - Cancer Clinical Research Office

location_facility: University of Tennessee Medical Center - Cancer Institute

location_facility: Florida Cancer Specialists & Research Institute (FCS) - Atlantis

location_facility: Sir Mortimer B Davis/Jewish General Hospital

location_facility: University of Pittsburgh Medical Center - Oncology

location_facility: Del-pesti Centrumkorhaz Orszagos Hematologiai és Infektologiai Intezet

location_facility: Columbia U - Herbert Irving Comprehensive Cancer Center

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS

location_facility: Oncology Hematology Care (OHC), Inc. - Kenwood Office

location_facility: Weill Cornell Medicine-New York Presbyterian Hospital


acronym: RA-BRIDGE

lead_sponsor: Eli Lilly and Company

summary: This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis.

sponsor_collaborators:
Eli Lilly and Company
Incyte Corporation

location_facility: Spitalul Judeean de Urgen Dr. Constantin Opri Baia Mare

location_facility: St Luke's Clinic - Intermountain Orthopaedics

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi

location_facility: Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum

location_facility: Pennsylvania Regional Center for Arthritis and Osteoporosis Research

location_facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

location_facility: DM Clinical Research/Rheumatology Clinic of Houston

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Nizhny Novgorod City Clinical Hospital Number 5

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Aintree University Hospital NHS Foundation Trust

location_facility: Inland Rheumatology & Osteoporosis Medical Group

location_facility: Reumatologisk Ambulatorie, Svendborg Hospital Odense Universitet Hospital

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

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: East Bay Rheumatology Medical Group, Inc

location_facility: Izmir Katip Celebi Ataturk Egitim Arastirma Hastanesi

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: M. F. Vladimirskiy Moscow Regional Research Clinical Institute

location_facility: Cincinnati Rheumatic Disease Study Group

location_facility: Hôpital Saint Joseph (Grand hôpital de Charleroi)

location_facility: Consorci Sanitari Integral. Hospital Moisés Broggi, Sant Joan Despí

location_facility: University Hospital Basel - Rheumatology

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: City Rheumatology Center (City Hospital #25)

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei

location_facility: Ankara University Ibni Sina Hospital - Rheumatology

location_facility: Rheuma Medicus- Zak��ad Opieki Zdrowotnej

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: The Center for Rheumatology and Bone Research

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Arizona Arthritis & Rheumatology Associates, P. C.

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Rheumatology Associates of South Florida

location_facility: Twoja Przychodnia Centrum Medyczne Nowa Sol

location_facility: Institut für Präventive Medizin & Klinische Forschung GbR

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Università degli studi della Campania Luigi Vanvitelli

location_facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research

location_facility: Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.

location_facility: Hamburger Rheuma Forschungszentrum I / Dres Raabe & Heintz

location_facility: Samodzielny Publiczny Zespol Opieki Zdrowotnej W Tomaszowie Lubelskim

location_facility: North-Western State Med. Univ. n.a. I.I. Mechnikov of MoH of

location_facility: Slaskie Centrum Reumatologii, Rehabilitacji I Zapobiegania Niepelnosprawnosci Im. Gen.J.Zietka

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

location_facility: Private Practice - Dr. Christine J. Leehealey

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

location_facility: Arthritis & Osteoporosis Clinic of Brazos Valley

title: A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis

type: Other Identifier

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Germany
Poland
Australia
Turkey
Czechia
France
Lithuania
Slovakia
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Spain
Greece
South Africa
Russian Federation
Israel


title: A NOVEL Observational longiTudinal studY on Patients With Asthma and/or COPD to Describe Patient Characteristics, Treatment Patterns and the Burden of Illness Over Time and to Identify Phenotypes and Endotypes.

acronym: NOVELTY

summary: The NOVEL Observational longiTudinal studY (NOVELTY) is an observational study of obstructive lung disease and is a multi-country, multi-centre, prospective, longitudinal cohort study which will recruit patients with a diagnosis, or suspected diagnosis, of asthma and/or Chronic Obstructive Pulmonary Disease (COPD). Patients will undergo clinical assessments and receive standard medical care as determined by their treating physician. Patients enrolled in NOVELTY will be followed up yearly by their treating physician for a total duration of three years. In addition, patients will be followed up remotely every 3 months. The NOVELTY study will collect data currently lacking to allow for multinational data collection to fill regional/local gaps and improve comparability across regions.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Hughes R, Rapsomaniki E, Janson C, Keen C, Make BJ, Burgel PR, Tomaszewski EL, Mullerova H, Reddel HK; NOVELTY study investigators. Frequent productive cough: Symptom burden and future exacerbation risk among patients with asthma and/or COPD in the NOVELTY study. Respir Med. 2022 Aug-Sep;200:106921. doi: 10.1016/j.rmed.2022.106921. Epub 2022 Jun 20.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repository_institution: Uppsala University - Uppsala University Publications

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Reddel HK, Vestbo J, Agusti A, Anderson GP, Bansal AT, Beasley R, Bel EH, Janson C, Make B, Pavord ID, Price D, Rapsomaniki E, Karlsson N, Finch DK, Nuevo J, de Giorgio-Miller A, Alacqua M, Hughes R, Mullerova H, Gerhardsson de Verdier M; NOVELTY study investigators. Heterogeneity within and between physician-diagnosed asthma and/or COPD: NOVELTY cohort. Eur Respir J. 2021 Sep 23;58(3):2003927. doi: 10.1183/13993003.03927-2020. Print 2021 Sep.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Aberdeen University - Aberdeen University Research Archive

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

publisher_dissemination: European Respiratory Society

ReferenceCitation: Karlsson N, Atkinson MJ, Mullerova H, Alacqua M, Keen C, Hughes R, Janson C, Make B, Price D, Reddel HK; NOVELTY study investigators. Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD. ERJ Open Res. 2021 Feb 1;7(1):00828-2020. doi: 10.1183/23120541.00828-2020. eCollection 2021 Jan.

evidence: oa journal (via doaj)

repositories_concat: PubMed Central;aura.abdn.ac.uk

ReferenceCitation: Reddel HK, Gerhardsson de Verdier M, Agusti A, Anderson G, Beasley R, Bel EH, Janson C, Make B, Martin RJ, Pavord I, Price D, Keen C, Gardev A, Rennard S, Svereus A, Bansal AT, Brannman L, Karlsson N, Nuevo J, Nyberg F, Young SS, Vestbo J. Prospective observational study in patients with obstructive lung disease: NOVELTY design. ERJ Open Res. 2019 Feb 1;5(1):00036-2018. doi: 10.1183/23120541.00036-2018. eCollection 2019 Feb.

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_concat: DiVA.org;PubMed Central;University of Melbourne - Minerva Access;aura.abdn.ac.uk;ora.ox.ac.uk

location_country:
Germany
Argentina
Australia
Brazil
Japan
Canada
France
Colombia
Denmark
United States
China
Italy
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Sweden


lead_sponsor: Halozyme Therapeutics

summary: The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).

location_facility: Semmelweis Egyetem - Onkohaematológiai Osztály

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Universitätsklinikum Halle-Universitätsklinik und Poliklinik

location_facility: Hospital de Clinicas de Porto Alegre - UFRGS

location_facility: Pacific Central Coast Health Centers: San Luis Obispo Oncology and Hematology Health Center

location_facility: Baylor College of Medicine - Baylor Clinic

location_facility: Sarah Cannon Research Institute UK (SCRI UK)

location_facility: Samuel Oschin Comprehensive Cancer Institute

location_facility: East Tallinn Central Hospital Oncology Center

location_facility: AO S. Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Cancro

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

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Swedish Cancer Institute/ Swedish Health Services

location_facility: Innovative Clinical Research Institution

location_facility: The Chaim Sheba Medical Center [Oncology]

location_facility: Semmelweis Egyetem - Isz. Bel, Onkológiai Részleg

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Keimyung University Dongsan Medical Center

location_facility: Vilniaus Universiteto ligonines Santariskiu Klinikos

location_facility: Fundação Amaral Cravalho / Hospital Amaral Carvalho

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

location_facility: David Geffen School of Medicine (DGSOM) at UCLA

location_facility: CENANTRON - Centro Avançado de Tratamento Oncologico

location_facility: AZ Maria Middelares - Campus Maria Middelares

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onko

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: US Oncology - Rocky Mountain Cancer Centers - Midtown

location_facility: Nemocnice Na Bulovce (Hospital Na Bulovce)

location_facility: Uniklinik Köln-Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum

location_facility: Regina Elena, Istituto Nazionale dei Tumori, IFO, IRCCS

location_facility: Klinicki bolnički centar Sestre milosrdnice

location_facility: Fundacao Pio XII Hospital De Câncer de Barretos

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: University of Wisconsin Health - UW Carbone Cancer Center

location_facility: The Sidney Kimmel Comprehensive Cancer Center

location_facility: Klinikum der Universität München - Campus Grosshadern

location_facility: Edinburgh Cancer Centre Western General Hospital

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: Fort Wayne Medical Oncology/Hematology, INC.

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung

location_facility: Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona

location_facility: University of Washington (UW) - Seattle Cancer Care Alliance

location_facility: Kaiser Permanente Franklin Medical Offices - Denver

location_facility: ICM Val d'Aurelle Saint Eloi - Departement Oncologie

location_facility: Seoul National University Bundang Hospital

location_facility: The Royal Marsden NHS Foundation Trust - Chelsea

location_facility: North Estonian Medical Centre Foundation Clinic of Oncology

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire (CHU) de Liege - Domaine Un

location_facility: St. Jude Hospital Yorba DBA Linda St. Joseph Heritage Health

location_facility: Egyesített Szent István és Szent László Kórház-Rendelőintéze

location_facility: SIA "Rigas Austrumu Kliniska Universitates Slimnica"

location_facility: The Royal Marsden NHS Foundation - Sutton

location_facility: Inova Dwight and Martha Schar Cancer Institute

location_facility: NYU Langone Medical Center - NYU Langone Arena Oncology

location_facility: Memorial Healthcare System - Memorial Cancer Institute

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Mount Sinai School of Medicine - The Tisch Cancer Institute

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Institut Català d'Oncologia-Hospital Germans Trias i Pujol

location_facility: Desert Hematology Oncology Medical Group, Inc.

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Subjects With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

location_country:
Germany
Poland
Australia
Brazil
Croatia
Czechia
Canada
France
Lithuania
Hungary
Denmark
United States
Latvia
Belgium
Estonia
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Israel


title: A Phase III Double-blind, Randomised, Parallel-Group Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human IFN Beta-1a) and Placebo in the Treatment of Patients With Moderate or Severe Acute Respiratory Distress Syndrome

acronym: INTEREST

summary: In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time which a patient need to be on the ventilator and improve patient's chances of survival. Currently there are no approved drugs for treating moderate or severe ARDS patients.

ReferenceCitation: Ranieri VM, Pettila V, Karvonen MK, Jalkanen J, Nightingale P, Brealey D, Mancebo J, Ferrer R, Mercat A, Patroniti N, Quintel M, Vincent JL, Okkonen M, Meziani F, Bellani G, MacCallum N, Creteur J, Kluge S, Artigas-Raventos A, Maksimow M, Piippo I, Elima K, Jalkanen S, Jalkanen M, Bellingan G; INTEREST Study Group. Effect of Intravenous Interferon beta-1a on Death and Days Free From Mechanical Ventilation Among Patients With Moderate to Severe Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2020 Feb 25;323(8):725-733. doi: 10.1001/jama.2019.22525.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

publisher_dissemination: American Medical Association

lead_sponsor: Faron Pharmaceuticals Ltd

sponsor_collaborators:
Faron Pharmaceuticals Ltd
Seventh Framework Programme

location_country:
Germany
Finland
Italy
United Kingdom
Belgium
Spain
Czechia
France

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Hospital Universitario de Gran Canaria Dr Negrin

location_facility: Lancashire Treaching Hospitals NHS Foundation Trust

location_facility: St George's University Hospitals, NHS Foundation Trust

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Universitätsmedizin Göttingen Klinik für Anästhesiologie

location_facility: AOU Città della Salute e della Scienza di Torino

location_facility: Charing Cross Hospital Imperial College Healthcare NHS Trust

location_facility: Universitätsklinikum Hamburg-Eppendorf Klinik für Intesivmedizin

location_facility: Klinikum Augsburg Klinik für Anästhesiologie

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Hammersmith Hospital Imperial College Healthcre NHS Trust

location_facility: University College London Hospitals, NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Charing Cross Hospital St Mary's Hospital, Imperial College Healthcare NHS Trust

location_facility: Universita degli Studi di Roma "La Sapienza"

location_facility: Bristol Royal Infirmary University Hospitals, Bristol Foundation Trust

location_facility: CHU Charleroi Site Hôpital Civil Marie Curie

location_facility: Hôpital Cochin, Réanimation Médicale Hospitalisation

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Kliniken der Stadt Köln Klinikum Merheim

location_facility: Universitätsklinik Leipzig Klinik und Poliklinik für Anäesthesiologie und Intensivtherapie

location_facility: Azienda Ospedaliera Universitaria Sant' Anna

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Universitätsklinikum Carl Gustav Carus Klinik für Anästhesiologie und Intensivmedizin

location_facility: Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

location_facility: Universitätsklinikum Bonn Klinik und Poliklinik für Anästhesiologie

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Nottingham University Hospitals NHS Trust


lead_sponsor: Geron Corporation

summary: The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory to Janus Kinase (JAK)-Inhibitor treatment.

ReferenceCitation: Mascarenhas J, Harrison CN, Kiladjian JJ, Komrokji RS, Koschmieder S, Vannucchi AM, Berry T, Redding D, Sherman L, Dougherty S, Peng L, Sun L, Huang F, Wan Y, Feller FM, Rizo A, Verstovsek S. Imetelstat in intermediate-2 or high-risk myelofibrosis refractory to JAK inhibitor: IMpactMF phase III study design. Future Oncol. 2022 Jul;18(22):2393-2402. doi: 10.2217/fon-2022-0235. Epub 2022 May 5.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Future Science Ltd

location_facility: CCA-Braga. Centro Clínico Académico - Hospital Braga

location_facility: Institut de cancérologie du Gard - Hematologie clinique

location_facility: Universitätsklinikum Mannheim - University of Heidelberg

location_facility: Budgetary Healthcare Institution of Omsk Region

location_facility: Hospital de Clinicas de Porto Alegre - UFRGS

location_facility: China Medical University Hospital - Hematology/Onc

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel

location_facility: All India Institute of Medical Sciences, Dept. of Hematology, New Delhi (All India Institute Of Medical Sciences)

location_facility: Hematology-Oncology Associates of Central New York (HOACNY)

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Deenanath Mangeshkar Hospital & Research Center

location_facility: AOU Città della Salute e della Scienza di Torino

location_facility: National University Cancer Institute (NCIS)

location_facility: Universitair Ziekenhuis Brussel - Myeloom Centrum Brussel (MCB)

location_facility: Hopital Cochin - Aphp Hôpitaux Universitaires Paris Centre

location_facility: Specialized Hospital for Active Therapy of Hematological dis

location_facility: The Oncology Institute - Innovative Clinical Research Institute (ICRI)

location_facility: CHU - HÃ´pital Saint Louis - Centre D'Investigations Cliniq

location_facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Sl

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_facility: Soroka Medical Center - Hematology Institute

location_facility: Fundacao Doutor Amaral Carvalho / Hospital Amaral Carvalho

location_facility: Arcispedale S Maria Nuova, AO di Reggio Emilia

location_facility: Hopital Avicenne - HÃ©matologie Clinique

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa LTDA

location_facility: CEPON Centro de Pesquisas Oncologicas SC

location_facility: Sakarya Research and Training Hospital - Medical Oncology

location_facility: Hospital A.C.Camargo Cancer Center - Clinical Oncology

location_facility: National Cancer Institute Center for Cancer Research

location_facility: Centre Hospitalier Du Mans - Cancérologie Médicale

location_facility: First Saint-Petersburg State Medical University n.

location_facility: GOU VPO Saratov State Medical University n.a. V.I.

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: V.A. Almazov National Medical Research Center

location_facility: University of California-San Diego/Moores UCSD Cancer Center

location_facility: Seoul National University Hospital - Department of Internal

location_facility: CHU de Nice - Hopital de l'Archet II - Pharmacie

location_facility: Marmara university pendik training and research hospital

location_facility: Pusan National University Hospital - Hematology and Oncology

location_facility: Instituto Português de Oncologia de Lisboa

location_facility: Bon Secours (Greenville) - St. Francis Cancer Center

title: A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat (GRN163L) Versus Best Available Therapy (BAT) in Patients With Intermediate-2 or High-risk Myelofibrosis (MF) Relapsed / Refractory (R/R) to Janus Kinase (JAK) Inhibitor

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
France
Colombia
Portugal
Hungary
Denmark
United States
India
Belgium
Malaysia
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Georgia
Russian Federation
Israel


title: Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial

acronym: EMERALD

summary: This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

ReferenceCitation: Bidard FC, Kaklamani VG, Neven P, Streich G, Montero AJ, Forget F, Mouret-Reynier MA, Sohn JH, Taylor D, Harnden KK, Khong H, Kocsis J, Dalenc F, Dillon PM, Babu S, Waters S, Deleu I, Garcia Saenz JA, Bria E, Cazzaniga M, Lu J, Aftimos P, Cortes J, Liu S, Tonini G, Laurent D, Habboubi N, Conlan MG, Bardia A. Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. J Clin Oncol. 2022 Oct 1;40(28):3246-3256. doi: 10.1200/JCO.22.00338. Epub 2022 May 18. Erratum In: J Clin Oncol. 2023 Aug 10;41(23):3962.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Bardia A, Aftimos P, Bihani T, Anderson-Villaluz AT, Jung J, Conlan MG, Kaklamani VG. EMERALD: Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer. Future Oncol. 2019 Oct;15(28):3209-3218. doi: 10.2217/fon-2019-0370. Epub 2019 Aug 20.

lead_sponsor: Stemline Therapeutics, Inc.

location_country:
Ireland
Italy
Portugal
Hungary
Argentina
Denmark
Australia
Israel
United Kingdom
Austria
Belgium
United States
Korea, Republic of
Spain
Greece
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Mater Misericordiae Ltd Mater Cancer Care Centre

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS)

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Oncol.Med. Addarii-Zamagni

location_facility: UC Davis Medical Center, Investigational Drug Service

location_facility: Fundacion CENIT para la Investigación en Neurociencias - Clinic

location_facility: Cancer Therapy and Research Center at UTHSCSA

location_facility: Northern Westchester Hospital Cancer Center

location_facility: Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques

location_facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology

location_facility: Centre Hospitalier de l'Ardenne - Site de Libramont

location_facility: PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona

location_facility: Presence Medical Group Hematology Oncology

location_facility: New Mexico Oncology Hematology Consultants - Oncology

location_facility: Centre DeLutte Contre Le Cancer - Institut Curie - Departement d'Oncologie Medica

location_facility: CHU de Quebec - Hopital du Saint Sacrement

location_facility: Oncología en Ciudad Autónoma de Buenos Aires

location_facility: Cliniques Universitaires Saint-Luc - Oncology

location_facility: Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute

location_facility: Instituto Português Oncologia Francisco Gentil do Porto

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Saint Barnabas Medical Center - Cancer Center

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Texas Oncology - Central Austin Cancer Center

location_facility: Clinical Research Facility, St. James's Hospital

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Sharett Institute of Oncology - Hadassah Medical Center

location_facility: Benaroya Research Institute at Virginia Mason

location_facility: Strasbourg Oncologie Libérale Centre de Radiothérapie

location_facility: AZ Nikolaas - Campus Sint-Niklaas Moerland

location_facility: Mass General North Shore Cancer Center - Oncology

location_facility: University General Hospital Of Patras - Dpt Of Medicine, Division Oncology

location_facility: AOU Maggiore della Carità - SC Oncologia

location_facility: Policlinico Universitario Campus Bio-medico, Università Campus Bio-medico di Roma,

location_facility: Texas Oncology-Presbyterian Cancer Center Dallas

location_facility: New York University Clinical Cancer Center

location_facility: Servicio de Oncología Médica Edificio Materno

location_facility: Hospital Senhora da Oliveira - Guimarães, E.P.E.

location_facility: US Oncology - Rocky Mountain Cancer Centers - Midtown

location_facility: Centre Oscar Lambret, Department de Cancérologie Sénologique

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

location_facility: Fort Wayne Medical Oncology And Hematology

location_facility: INDC Entité Jolimontoise - CH de Jolimont-Lobbes

location_facility: Kent Oncology Centre, Maidstone Hospital

location_facility: Pikeville Medical Center - Oncology/Hematology

location_facility: Rabin Medical Center - Beilinson Hospital - Davidoff Cancer

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Oncology and Haematology Clinic - Michael Garron Hospital

location_facility: Hôpital Privé Jean Mermoz Département Pharmacie

location_facility: Tel Aviv Sourasky Medical Center - Oncology

location_facility: Hospital Universitario Son Espases, Servicio de Oncología

location_facility: Texas Oncology-Methodist Dallas Cancer Center

location_facility: DiMI, Dipartimento di Medicina interna e Specialità mediche,

location_facility: Seoul National University Bundang Hospital

location_facility: Texas Oncology - The Woodlands, Gynecologic Oncology

location_facility: Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques

location_facility: Chicago Association for Research and Education in Science

location_facility: Department für Hämato-Onkologie - LKH Hochsteiermark

location_facility: Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System

location_facility: Weinberg Cancer Institute at Franklin Square

location_facility: Piedmont Cancer Institute, P.C. - Oncology

location_facility: IRCCS Istituto Clinico Humanitas Humanitas Cancer Center

location_facility: Mass General Cancer Center at Newton Wellesley - Oncology

location_facility: Carolina Institute For Clinical Research

location_facility: The Gynecologic Oncology Center at Mercy

location_facility: Beaumont Hospital Cancer Clinical Trials Unit

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Hospital Universitario de Fuenlabrada. Servicio de Oncología

location_facility: McGill University Health Centre - Cedars Cancer Center - Oncology

location_facility: Instituto Português de Oncologia de Coimbra

location_facility: Hopital Trousseau - Service d'Oncologie Medicale

location_facility: Instituto Português de Oncologia do Porto

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Centre François Baclesse Service Pharmacie

location_facility: Onkologisk Afdeling, Lillebælt Hospital, Vejle

location_facility: Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital

location_facility: Institut Jules Bordet - Oncologie Médicale

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Moores Cancer Center at UC San Diego Health

location_facility: Brig Center For Cancer Care And Survivorship

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: Via G. Dottore, 1 Sc Oncologia Medica Azienda Ospedaliera di Perugia


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis

summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Hungary
Denmark
Switzerland
United States
India
Belgium
China
Peru
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Israel

location_facility: Washington University School of Medicine in St. Louis

location_facility: Medical University of South Carolina- College of Medicine

location_facility: Pulmonary Specialists of the Palm Beaches

location_facility: University of Michigan Health System - A. Alfred Taubman Health Care Center - Pulmonary Clinic

location_facility: (UPMC) - Dorothy P. and Richard P. Simmons Center for Interstitial Lung Diseases (ILD)

location_facility: University Hospitals Cleveland Medical Center

location_facility: NorthShore University HealthSystem - NorthShore Research Institute

location_facility: Coastal Pulmonary & Critical Care, P.L.C.

location_facility: McGovern Medical School - UT Physicians - Pulmonary Medicine - Texas Medical Center Location

location_facility: Western Washington Medical Group (WWMG) - Everett - Silver Lake Medical Center Location


title: A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)

summary: The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

location_country:
Germany
Poland
Australia
Japan
Czechia
Canada
France
Denmark
United States
Romania
Belgium
Italy
Norway
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Israel

location_facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

location_facility: University of California, Irvine (UCI) Health - UC Irvine Medical Center

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

location_facility: Washington University School of Medicine

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Novant Health Cancer Institute - Elizabeth

location_facility: University of California Davis (UC Davis) Comprehensive Cancer Center

location_facility: Hospital of the University of Pennsylvania

location_facility: Winship Cancer Institute, Emory University

location_facility: Columbia University Irving Medical Center

location_facility: Centre Hospitalier Universitaire de Poitiers


title: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)

summary: This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

ReferenceCitation: Eyre TA, Shah NN, Dreyling M, Jurczak W, Wang Y, Cheah CY, Song Y, Gandhi M, Chay C, Sharman J, Andorsky DJ, Messersmith HM, Ruppert AS, Muthig VA, Ito R, Wang ML. BRUIN MCL-321: phase III study of pirtobrutinib versus investigator choice of BTK inhibitor in BTK inhibitor naive mantle cell lymphoma. Future Oncol. 2022 Nov;18(36):3961-3969. doi: 10.2217/fon-2022-0976. Epub 2022 Nov 15.

ReferenceCitation: Ito R, Eyre TA, Shah NN, Gouill SL, Dreyling M, Vandenberghe E, Jurczak W, Wang Y, Cheah CY, Gandhi M, Chay C, Sharman J, Andorsky DJ, Song Y, Stark A, Muthig V, Wang ML. MCL-135 BRUIN MCL-321, a Phase 3 Open-Label, Randomized Study of Pirtobrutinib Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated, BTK Inhibitor Naive Mantle Cell Lymphoma (Trial in Progress). Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S395-S396. doi: 10.1016/S2152-2650(22)01570-1.

oa_host_type: closed

lead_sponsor: Loxo Oncology, Inc.

sponsor_collaborators:
Loxo Oncology, Inc.
Eli Lilly and Company

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Japan
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Hematology Oncology Associates Of Northern New Jersey

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: The First Affiliated Hospital of Henan Science and Technology University

location_facility: Klinikum der Universität München Großhadern

location_facility: InVO - Institut für Versorgungsforschung in der Onkologie GbR

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: GUZ of Moscow City Clinical Hospital n.a. S.P. Botkin

location_facility: Blood Institute of the Chinese Academy of Medical science

location_facility: Texas Oncology - Bayler Charles A. Sammons Cancer Center

location_facility: University of Kentucky Markey Cancer Center

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Southern Medical University Nanfang Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Arizona Oncology Associates, P.C. - HOPE

location_facility: Aarhus Universitetshospital, Aarhus Sygehus

location_facility: Willamette Valley Cancer Institute & Research Ctr.

location_facility: IEP - Instituto de Ensino e Pesquisas São Lucas

location_facility: Icon Cancer Care - The Wesley Medical Centre

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Shengjing Hospital of China Medical University

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: The First Affiliated Hospital of Nanchang University

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

location_facility: Centre hospitalier universitaire de Haut Leveque

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

location_facility: BP A Beneficencia Portuguesa da Sao Paulo

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

location_facility: Oncology-Hematology Associates of West Broward

location_facility: Irmandade da Santa Casa de Misericordia de Sao Paulo

location_facility: Pole Regionalde Cancérologie(CHU de Poitiers)

location_facility: Cancer Center Office of Clinical Research

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte

location_facility: Mercy Health-Paducah Medical Oncology and Hematology

location_facility: Universitätsmedizin Johannes Gutenberg Universität Mainz

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Albert Einstein Sociedade Beneficente Israelita Brasileira

location_facility: Presidio Ospedaliero Civile Santi Antonio e Biagio

location_facility: State Medical University named after I.P. Pavlov

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Ospedale di Circolo e Fondazione Macchi Varese

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Kyoto Furitsu Medical University Hospital

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Beijing Chaoyang Hospital, Capital Medical University

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency

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

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: West China Hospital of Sichuan University

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: City Hospital, Nottingham University Hospitals

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

location_facility: Wake Forest University School of Medicine

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"


title: A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1

summary: The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

lead_sponsor: Celgene

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Portugal
United States
Romania
Belgium
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Israel

location_facility: Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

location_facility: The University of Mississippi Medical Center

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)

location_facility: Xiangya Hospital Central South University

location_facility: Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire Carémeau

location_facility: Hospital Privado Universitario de Córdoba

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Shengjing Hospital of China Medical University

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

location_facility: University of Wisconsin Hospitals and Clinics

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

location_facility: Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

location_facility: Seoul National University Bundang Hospital

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

location_facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri

location_facility: Central Care Cancer Center - Garden City

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Istanbul University, Istanbul Faculty of Medicine

location_facility: The First Afffiliated Hospital of Chongqing Medical University

location_facility: Private Practice - Dr. James R. Berenson

location_facility: Japan Community Healthcare Organization Kyushu Hospital

location_facility: The West Clinic, PLLC dba West Cancer Center

location_facility: Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre

location_facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

location_facility: Hematology Oncology Associates of Fredericksburg


title: A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION

summary: The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Finland
Germany
Poland
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hungary
United States
India
Belgium
China
Italy
Norway
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Israel

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University Of Mississippi Medical Center

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (US

location_facility: Institute of hematology&blood disease hospital

location_facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)

location_facility: Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny

location_facility: OhioHealth Arthur G.H. Bing, MD, Cancer Center

location_facility: Theageneio Cancer Hospital of Thessaloniki

location_facility: Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórhá

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Institut Català d'Oncologia - L'Hospitalet

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,

location_facility: Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Aydın Adnan Menderes Universitesi Hastanesi

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: University Hospital,Kyoto Prefectural University of Medicine

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Rajiv Gandhi Cancer Institute And Research Centre

location_facility: Chonnam National University Hwasun Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Tongji Hospital; Tongji Medical college; Huazhong University of Science and Technonogy

location_facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi

location_facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin

location_facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site God

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)

location_facility: Institut Catala d' Oncologia. Hospital Germans Trias i Pujol

location_facility: Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital

location_facility: BP - A Beneficencia Portuguesa de São Paulo

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

location_facility: Himalayan Institute Hospital Trust University

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Azienda Ospedaliero Universitaria Senese

location_facility: University of Mississippi Medical Center

location_facility: Windsor Regional Hospital Cancer Program

location_facility: Centro de Pesquisa Clínica - Área Administrativa

location_facility: Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUS

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Centre Hospitalier Universitaire de Poitiers


summary:
The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Part 1 of the study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in transfusion-dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Part 2 of the study.

An Extension Phase has been included to allow continued treatment for those subjects who are benefitting from imetelstat and to continue to evaluate the long-term safety, overall survival (OS), and disease progression, including progression to acute myeloid leukemia (AML) in transfusion-dependent participants with low or immediate-1 risk MDS that is relapsed/refractory to ESA treatment.

ReferenceCitation: Steensma DP, Fenaux P, Van Eygen K, Raza A, Santini V, Germing U, Font P, Diez-Campelo M, Thepot S, Vellenga E, Patnaik MM, Jang JH, Varsos H, Bussolari J, Rose E, Sherman L, Sun L, Wan Y, Dougherty S, Huang F, Feller F, Rizo A, Platzbecker U. Imetelstat Achieves Meaningful and Durable Transfusion Independence in High Transfusion-Burden Patients With Lower-Risk Myelodysplastic Syndromes in a Phase II Study. J Clin Oncol. 2021 Jan 1;39(1):48-56. doi: 10.1200/JCO.20.01895. Epub 2020 Oct 27.

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

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Instytut patolohii krovi ta transfusiynoi medytsyny NAMN Ukr

location_facility: AOU di Bologna Policlinico S. Orsola Malpighi

location_facility: Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital

location_facility: Wojewódzki Szpital Specjalistyczny sp.z o.o.

location_facility: Vanderbilt University Medical - Hematology-Oncology

location_facility: University of Alberta Hospital - Hematology Research

location_facility: Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects

location_facility: AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi

location_facility: Kantonsspital St. Gallen - Onkologie/Hämatologie

location_facility: University of South Florida (USF) - H. Lee Moffitt Cancer Center

location_facility: A.O. Universitaria Policlinico Tor Vergata

location_facility: KNP "Cherkaskyi oblasnyi onkolohichnyi dyspanser Cherkaskoi

location_facility: The Ohio State Comprehensive Cancer Center

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

location_facility: Texas Oncology/Methodist Charlton Cancer Center

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: AO S. Andrea, Università degli Studi di Roma La Sapienza

location_facility: Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

location_facility: Ege Universitesi Tip Fakultesi - Hematology

location_facility: Washington University School of Medicine

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Fachärztliche Gemeinschaftspraxis mit Schwerpunkt

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Nottingham City Hospital - Clinical Haematology

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

location_facility: Fred Hutchinson Cancer Research Center (FHCRC)

location_facility: SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii

location_facility: Gachon University Gil Medical Center - oncology

location_facility: KZ "Miska bahatoprofilna klinichna likarnia No4", hematolohi

location_facility: Pusan National University Hospital - Hematology and Oncology

location_facility: Ankara University Medical Faculty - Hematology

location_facility: Studienzentrum für Hämatologie, Onkologie,Diabetologie, Endoskopie und Fußambulanz

location_facility: Azienda Ospedaliera Universitaria Careggi di Firenze

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

title: A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

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title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

summary: The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.

ReferenceCitation: Motzer RJ, McDermott DF, Escudier B, Burotto M, Choueiri TK, Hammers HJ, Barthelemy P, Plimack ER, Porta C, George S, Powles T, Donskov F, Gurney H, Kollmannsberger CK, Grimm MO, Barrios C, Tomita Y, Castellano D, Grunwald V, Rini BI, McHenry MB, Lee CW, McCarthy J, Ejzykowicz F, Tannir NM. Conditional survival and long-term efficacy with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma. Cancer. 2022 Jun 1;128(11):2085-2097. doi: 10.1002/cncr.34180. Epub 2022 Apr 5.

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

ReferenceCitation: Labriola MK, George DJ. Setting a new standard for long-term survival in metastatic kidney cancer. Cancer. 2022 Jun 1;128(11):2058-2060. doi: 10.1002/cncr.34177. Epub 2022 Apr 5. No abstract available.

ReferenceCitation: Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthelemy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Leung D, Saggi SS, Lee CW, McHenry MB, Motzer RJ. First-line Nivolumab plus Ipilimumab Versus Sunitinib in Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial. Eur Urol. 2022 Mar;81(3):266-271. doi: 10.1016/j.eururo.2021.10.001. Epub 2021 Nov 5.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

version: submittedVersion

ReferenceCitation: Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthelemy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Saggi SS, McHenry MB, Motzer RJ. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial. ESMO Open. 2020 Nov;5(6):e001079. doi: 10.1136/esmoopen-2020-001079.

ReferenceCitation: Motzer RJ, Escudier B, McDermott DF, Aren Frontera O, Melichar B, Powles T, Donskov F, Plimack ER, Barthelemy P, Hammers HJ, George S, Grunwald V, Porta C, Neiman V, Ravaud A, Choueiri TK, Rini BI, Salman P, Kollmannsberger CK, Tykodi SS, Grimm MO, Gurney H, Leibowitz-Amit R, Geertsen PF, Amin A, Tomita Y, McHenry MB, Saggi SS, Tannir NM. Survival outcomes and independent response assessment with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma: 42-month follow-up of a randomized phase 3 clinical trial. J Immunother Cancer. 2020 Jul;8(2):e000891. doi: 10.1136/jitc-2020-000891. Erratum In: J Immunother Cancer. 2021 May;9(5):

ReferenceCitation: Ambavane A, Yang S, Atkins MB, Rao S, Shah A, Regan MM, McDermott DF, Michaelson MD. Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma. Immunotherapy. 2020 Jan;12(1):37-51. doi: 10.2217/imt-2019-0199. Epub 2020 Jan 29.

ReferenceCitation: Tomita Y, Kondo T, Kimura G, Inoue T, Wakumoto Y, Yao M, Sugiyama T, Oya M, Fujii Y, Obara W, Motzer RJ, Uemura H. Nivolumab plus ipilimumab versus sunitinib in previously untreated advanced renal-cell carcinoma: analysis of Japanese patients in CheckMate 214 with extended follow-up. Jpn J Clin Oncol. 2020 Jan 24;50(1):12-19. doi: 10.1093/jjco/hyz132.

ReferenceCitation: Motzer RJ, Rini BI, McDermott DF, Aren Frontera O, Hammers HJ, Carducci MA, Salman P, Escudier B, Beuselinck B, Amin A, Porta C, George S, Neiman V, Bracarda S, Tykodi SS, Barthelemy P, Leibowitz-Amit R, Plimack ER, Oosting SF, Redman B, Melichar B, Powles T, Nathan P, Oudard S, Pook D, Choueiri TK, Donskov F, Grimm MO, Gurney H, Heng DYC, Kollmannsberger CK, Harrison MR, Tomita Y, Duran I, Grunwald V, McHenry MB, Mekan S, Tannir NM; CheckMate 214 investigators. Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial. Lancet Oncol. 2019 Oct;20(10):1370-1385. doi: 10.1016/S1470-2045(19)30413-9. Epub 2019 Aug 16. Erratum In: Lancet Oncol. 2019 Aug 21;: Lancet Oncol. 2020 Jun;21(6):e304. Lancet Oncol. 2020 Nov;21(11):e518.

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

ReferenceCitation: Cella D, Grunwald V, Escudier B, Hammers HJ, George S, Nathan P, Grimm MO, Rini BI, Doan J, Ivanescu C, Paty J, Mekan S, Motzer RJ. Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial. Lancet Oncol. 2019 Feb;20(2):297-310. doi: 10.1016/S1470-2045(18)30778-2. Epub 2019 Jan 15. Erratum In: Lancet Oncol. 2019 Jun;20(6):e293.

ReferenceCitation: Motzer RJ, Tannir NM, McDermott DF, Aren Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthelemy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Tampere University - Tampere University Institutional Repository

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

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Sweden
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