title: Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty

summary: The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).

lead_sponsor: DePuy Orthopaedics

location_country:
Austria
Netherlands
Germany
France
Ireland
New Zealand
United States
United Kingdom
Canada

location_facility: Hampton Roads Orthopaedics and Sports Medicine

location_facility: Texas Tech University Heath Science Center

location_facility: Sevice de Chirurgie Orthoedique et Traumatologique

location_facility: South Infirmary Victoria University Hospital

location_facility: Foothills Medical Centre, University of Calgary

location_facility: Krankenhaus der Barmherzigen Schwestern Ried im Innkreis

location_facility: Nottingham University Hospitals NHS Trust


title: Ventricular Tachycardia Antiarrhythmics or AblatioN In Structural Heart Disease 2

summary: A multicenter, randomized clinical trial to assess whether catheter ablation or antiarrhythmic drug therapy provides the most effective control of important clinical outcomes for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia (VT).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.

name: Knight Cardiovascular Institute, Oregon Health and Science University, Portland, OR (B.K., E.C.S., B.N.).

family: Kheiri

full_name: Babikir Kheiri

given: Babikir

sequence: first

name: Department of Internal Medicine (M.B., Y.Z., L.R., H.H.K., G.B.), Hurley Medical Center/Michigan State University, Flint.

family: Barbarawi

full_name: Mahmoud Barbarawi

given: Mahmoud

sequence: additional

family: Zayed

full_name: Yazan Zayed

given: Yazan

name: Michigan Medicine, University of Michigan, Ann Arbor (M. Hicks).

family: Hicks

full_name: Michael Hicks

given: Michael

name: Division of Cardiology, West Virginia University School of Medicine, Morgantown (M.O.).

family: Osman

full_name: Mohammed Osman

given: Mohammed

family: Rashdan

full_name: Laith Rashdan

given: Laith

family: Kyi

full_name: Htay Htay Kyi

given: Htay Htay

family: Bachuwa

full_name: Ghassan Bachuwa

given: Ghassan

name: Division of Cardiology (M. Hassan), Hurley Medical Center/Michigan State University, Flint.

family: Hassan

full_name: Mustafa Hassan

given: Mustafa

family: Stecker

full_name: Eric C. Stecker

given: Eric C.

family: Nazer

full_name: Babak Nazer

given: Babak

name: Brigham and Women’s Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA (D.L.B.).

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Circulation: Arrhythmia and Electrophysiology

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ipd_sharing: No

lead_sponsor: John Sapp

location_country:
United States
Canada
France

location_facility: Institut Universitaire de cardiologie et pneumologie de Quebec - Laval University Hosptial

location_facility: Centre Hospitalier Univesitaire de Sherbrooke

location_facility: Centre Hospitalier de l'Universitaire de Montreal

location_facility: Fraser Health Authority - Royal Columbian Hospital

location_facility: Queen's University Health Sciences Centre

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Ongoing


intervention_type: Biological

status: Completed

lead_sponsor: Archigen Biotech Limited

enrollment_type: Actual

location_country:
Italy
South Africa
Chile
Mexico
Germany
France
Czechia
Hungary
Australia
Spain
Turkey
United States
United Kingdom
Korea, Republic of

location_facility:
Research site
Research Site
Reasearch site

study_completion_date_type: Actual

source: euctr

title: A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma

summary: This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden Follicular Lymphoma.

status_simplified: Completed


type: Other Identifier

type: EudraCT Number

title: A Phase 1a/1b Study of a Novel Anti-PD-L1 Checkpoint Antibody (LY3300054) Administered Alone or in Combination With Other Agents in Advanced Refractory Solid Tumors (Phase 1a/1b Anti-PD-L1 Combinations in Tumors-PACT)

acronym: PACT

summary: The main purpose of this study is to evaluate the safety and tolerability of anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced refractory solid tumors.

status: Active, not recruiting

design_allocation: Non-Randomized

ReferenceCitation: Patnaik A, Yap TA, Chung HC, de Miguel MJ, Bang YJ, Lin CC, Su WC, Italiano A, Chow KH, Szpurka AM, Yu D, Zhao Y, Carlsen M, Schmidt S, Vangerow B, Gandhi L, Xu X, Bendell J. Safety and Clinical Activity of a New Anti-PD-L1 Antibody as Monotherapy or Combined with Targeted Therapy in Advanced Solid Tumors: The PACT Phase Ia/Ib Trial. Clin Cancer Res. 2021 Mar 1;27(5):1267-1277. doi: 10.1158/1078-0432.CCR-20-2821. Epub 2020 Nov 23.

family: Patnaik

full_name: Amita Patnaik

given: Amita

family: Yap

full_name: Timothy A. Yap

given: Timothy A.

family: Chung

full_name: Hyun Cheol Chung

given: Hyun Cheol

family: de Miguel

full_name: Maria J. de Miguel

given: Maria J.

family: Bang

full_name: Yung-Jue Bang

given: Yung-Jue

family: Lin

full_name: Chia-Chi Lin

given: Chia-Chi

family: Su

full_name: Wu-Chou Su

given: Wu-Chou

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Chow

full_name: Kay Hoong Chow

given: Kay Hoong

family: Szpurka

full_name: Anna M. Szpurka

given: Anna M.

family: Yu

full_name: Danni Yu

given: Danni

family: Zhao

full_name: Yumin Zhao

given: Yumin

family: Carlsen

full_name: Michelle Carlsen

given: Michelle

family: Schmidt

full_name: Shelly Schmidt

given: Shelly

family: Vangerow

full_name: Burkhard Vangerow

given: Burkhard

family: Gandhi

full_name: Leena Gandhi

given: Leena

family: Xu

full_name: Xiaojian Xu

given: Xiaojian

family: Bendell

full_name: Johanna Bendell

given: Johanna

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

lead_sponsor: Eli Lilly and Company

location_country:
United States
France
Belgium
Spain
Canada
Korea, Republic of
Taiwan

location_facility: Severance Hospital Yonsei University Health System

location_facility: University of Texas MD Anderson Cancer Center

intervention_type: Drug


lead_sponsor: Boehringer Ingelheim

location_country:
Italy
United States
Serbia
Hong Kong
Mexico
Philippines
Germany
Spain
France
Czechia
Greece
Japan
Malaysia
Poland
Thailand
Australia
Portugal
Canada
United Kingdom
Korea, Republic of

acronym:
POC in lupus nephrits

 Preuve de concept dans la néphropathie lupique

location_facility: General University Hospital Prague 2, Nephrology Clinic

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Integral Rheumatology and Immunology Specialist

location_facility: Hospital of the University of Occupational and Environmental Health

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

location_facility: St. Marianna University School of Medicine Hospital

location_facility: CHU de Quebec-Universite Laval Research Centre

location_facility: Feinstein Institute for Medical Research

location_facility: Norbert Barlicki University Clinical Hospital No.1, Lodz

location_facility: University Clinical Hospital in Bialystok I

location_facility: University General Hospital of Heraklion

location_facility: NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: Instituto Nacional de Cs Médicas y Nutrición S Zubiran

location_facility: Angeles University Foundation Medical Center

location_facility: Azienda Ospedaliera Universitaria di Padova

title: A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Effect of BI 655064 Administered as Sub-cutaneous Injections, on Renal Response After One Year of Treatment, in Patients With Active Lupus Nephritis

summary: The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.


lead_sponsor: MorphoSys AG

location_country:
Finland
Romania
Australia
Taiwan
Croatia
France
Poland
Canada
Korea, Republic of
Singapore
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Austria
Serbia
Czechia
Israel
New Zealand
Spain
Turkey

acronym: B-MIND

location_facility:
MorphoSys
MorphoSys Research SIte
Morphosys Research site
Morphosys Research Site
MorphoSys Research Site

title: A Phase 2/3, Randomised, Multicentre Study of Tafasitamab With Bendamustine Versus Rituximab With Bendamustine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT)

summary: The purpose of the study is to compare the safety and efficacy of Tafasitamab with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL.


title: A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

acronym: PLUS

summary: The purpose of the study was to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).

ipd_sharing: Yes

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Global Development, Inc.

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

location_facility:
Site US01063
Site US01061
Site US01072
Site FR33002
Site ES34006
Site US01015
Site CA15003
Site GB44004
Site US01009
Site CZ42006
Site US01031
Site CA15002
Site DE49005
Site US01068
Site PL48004
Site GB44011
Site US01070
Site US01075
Site CZ42004
Site DE49006
Site IT39010
Site PL48007
Site DE49007
Site ES34009
Site US01079
Site CA15008
Site US01042
Site US01012
Site US01021
Site US01016
Site US01078
Site CA15001
Site CZ42003
Site CZ42001
Site DE49002
Site IT39003
Site IT39001
Site ES34003
Site IT39004
Site US01041
Site US01034
Site US01060
Site IT39006
Site ES34007
Site US01026
Site DE49004
Site GB44005
Site CA15009
Site GB44002
Site US01056
Site US01081
Site US01005
Site CA15005
Site CZ42005
Site DE49003
Site US01064
Site US01094
Site US01027
Site US01097
Site CA15014
Site ES34001
Site ES34002
Site DE49001
Site US01003
Site CA15011
Site FR33004
Site IT39002
Site PL48005
Site US01069
Site US01025
Site IT39008
Site ES34004
Site IT39005
Site PL48001
Site PL48006
Site US01029
Site US01067
Site GB44006
Site US01019


title: A Phase 1 Dose Escalation and Cohort Expansion Study of ERY974, An Anti-Glypican3 (GPC3)/CD3 Bispecific Antibody, in Patients With Advanced Solid Tumors

summary: This is the open label, multicenter Phase 1 study which consists of a dose escalation to determine the maximum tolerated dose (MTD) and cohort expansion to obtain a preliminary evaluation of anti-tumor activity. ERY974 is intravenously injected to patients with Glypican 3 positive advanced solid tumors until unacceptable toxicity or disease progression.

lead_sponsor: Chugai Pharmaceutical

location_country:
United States
France
Netherlands


title: Multi-center, Randomized, Parallel, Adaptive, Controlled Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control (CSII, MDI and SAP) at Home

summary: The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)

lead_sponsor: Medtronic Diabetes

location_country:
Italy
United States
Sweden
France
Spain
Germany
United Kingdom
Canada

location_facility: Dept Internal Medicine, Örebro University Hospital

location_facility: Texas Children's Hospital / Baylor University

location_facility: Diabeteszentrum für Kinder und Jugendliche, Kinder- und Jugendkrankenhaus Auf der Bult

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: Indiana University Health Riley Hospital for Children

location_facility: Westminster Endocrine & Diabetes Research Society

location_facility: Center of Excellence in Diabetes & Endocrinology

location_facility: University of South Florida Diabetes Center

location_facility: Diabetes and Glandular Disease Clinic, P.A.

intervention_type: Device


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:
Italy
Austria
Brazil
Mexico
Germany
France
Czechia
Argentina
Belgium
Russian Federation
Spain
Turkey
United States
Taiwan

acronym: Next MONARCH 1

location_facility: Republic Oncology Dispensary of MoH of Republic Tatarstan

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA

location_facility: The Center for Cancer and Blood Disorders

location_facility: St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)

location_facility: Saint-Petersburg city clinical oncology dispensary

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

title: A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

summary: The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.


title: Phase 3B Open-Label Extension Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With GNE Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)

summary: The objective of this study is to evaluate the long-term safety and efficacy of Ace-ER treatment in subjects with GNEM.

status: Terminated

lead_sponsor: Ultragenyx Pharmaceutical Inc

location_country:
Italy
France
Bulgaria
Israel
United States
United Kingdom
Canada

location_facility: Washington University School of Medicine, St. Louis

location_facility: Institut de Myologie GH Pitié-Salpêtrière

location_facility: Hadassah-Hebrew University Medical Center

status_simplified: Unknown


ReferenceCitation: Danne T, Tamborlane WV, Malievsky OA, Franco DR, Kawamura T, Demissie M, Niemoeller E, Goyeau H, Wardecki M, Battelino T. Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6-17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial. Diabetes Care. 2020 Jul;43(7):1512-1519. doi: 10.2337/dc19-1926. Epub 2020 May 19.

family: Danne

full_name: Thomas Danne

given: Thomas

family: Tamborlane

full_name: William V. Tamborlane

given: William V.

family: Malievsky

full_name: Oleg A. Malievsky

given: Oleg A.

family: Franco

full_name: Denise R. Franco

given: Denise R.

family: Kawamura

full_name: Tomoyuki Kawamura

given: Tomoyuki

family: Demissie

full_name: Marek Demissie

given: Marek

family: Niemoeller

full_name: Elisabeth Niemoeller

given: Elisabeth

family: Goyeau

full_name: Harmonie Goyeau

given: Harmonie

family: Wardecki

full_name: Marek Wardecki

family: Battelino

full_name: Tadej Battelino

given: Tadej

journal_name: Diabetes Care

oa_colors: green other

oa_host_type: publisher;repository

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

host_type: repository

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6–17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

lead_sponsor: Sanofi

location_country:
North Macedonia
Romania
Russian Federation
Denmark
France
Japan
Poland
Argentina
Canada
Chile
Sweden
Bulgaria
Hungary
United States
Germany
United Kingdom
Italy
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Latvia

acronym: EDITION JUNIOR

location_facility:
Investigational Site Number 8400035
Investigational Site Number 8400038
Investigational Site Number 1000005
Investigational Site Number 2760003
Investigational Site Number 7240003
Investigational Site Number 2030003
Investigational Site Number 0320006
Investigational Site Number 6420005
Investigational Site Number 3800006
Investigational Site Number 1520003
Investigational Site Number 3800004
Investigational Site Number 0760001
Investigational Site Number 4840005
Investigational Site Number 1240006
Investigational Site Number 3480001
Investigational Site Number 8400010
Investigational Site Number 0760005
Investigational Site Number 8400029
Investigational Site Number 8260001
Investigational Site Number 6880002
Investigational Site Number 3480002
Investigational Site Number 6160003
Investigational Site Number 0320002
Investigational Site Number 3760003
Investigational Site Number 6420007
Investigational Site Number 3800001
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Investigational Site Number 3800003
Investigational Site Number 1000001
Investigational Site Number 6880004
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Investigational Site Number 1000004
Investigational Site Number 1240002
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Investigational Site Number 2030001
Investigational Site Number 0760006
Investigational Site Number 2760001
Investigational Site Number 3760001
Investigational Site Number 4840001
Investigational Site Number 6420004
Investigational Site Number 3920002
Investigational Site Number 0320007
Investigational Site Number 3480007
Investigational Site Number 8400015
Investigational Site Number 6160001
Investigational Site Number 7240002
Investigational Site Number 8260002
Investigational Site Number 3920006
Investigational Site Number 2760004
Investigational Site Number 3920003
Investigational Site Number 8400030
Investigational Site Number 8400032
Investigational Site Number 3920007
Investigational Site Number 1520002
Investigational Site Number 6430003
Investigational Site Number 3920005
Investigational Site Number 4280001
Investigational Site Number 3480005
Investigational Site Number 4840002
Investigational Site Number 6420006
Investigational Site Number 8400016
Investigational Site Number 2760002
Investigational Site Number 3480003
Investigational Site Number 7240004
Investigational Site Number 7240005
Investigational Site Number 0760004
Investigational Site Number 0320001
Investigational Site Number 7240006
Investigational Site Number 7520002
Investigational Site Number 1240003
Investigational Site Number 6160006
Investigational Site Number 7240001
Investigational Site Number 2080001
Investigational Site Number 4840003
Investigational Site Number 6160007
Investigational Site Number 6430002
Investigational Site Number 8400005
Investigational Site Number 0760002
Investigational Site Number 8400008
Investigational Site Number 2500002
Investigational Site Number 8400037
Investigational Site Number 4280002
Investigational Site Number 6160005
Investigational Site Number 6420003
Investigational Site Number 8260004
Investigational Site Number 8400034
Investigational Site Number 2030005
Investigational Site Number 4840004
Investigational Site Number 0320004
Investigational Site Number 6430001
Investigational Site Number 3920004
Investigational Site Number 1520006
Investigational Site Number 1520007
Investigational Site Number 1520004
Investigational Site Number 8260005
Investigational Site Number 3480006
Investigational Site Number 0320005
Investigational Site Number 3760006
Investigational Site Number 0320003
Investigational Site Number 3480004
Investigational Site Number 3760002
Investigational Site Number 6880003
Investigational Site Number 1240005
Investigational Site Number 8070001
Investigational Site Number 6160004

title: 6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents Age 6 - 17 Years With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

summary:
Primary Objective:

To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus.

.

Secondary Objectives:

To compare HOE901-U300 and Lantus in terms of:

Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG).
To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.


title: A Phase I/II, Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis

summary: This trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose (SAD) treatment group. The second group will enroll adult subjects with CF, including those on background treatment with ORKAMBI® and those not on a cystic fibrosis transmembrane conductance regulator (CFTR) modulator, into a multiple ascending dose (MAD) treatment group. Part B will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for a minimum of 3 months into a Phase II treatment group consisting of two cohorts. Part C will enroll adult subjects with CF, including those on background treatment with KALYDECO® and those not on a CFTR modulator, into a Phase II treatment group consisting of three cohorts. Approximately 136 subjects will be enrolled.

lead_sponsor: Proteostasis Therapeutics, Inc.

location_country:
Germany
France
Denmark
United States
Canada

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: St. Paul's Hospital Pacific Lung Research Center

location_facility: Northwestern University Memorial Hospital

location_facility: University of Florida College of Medicine

location_facility: St. Luke's Cystic Fibrosis Center of Idaho

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants

location_facility: Institut de Recherches Cliniques de Montreal

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Universitaetsklinikum Frankfurt-Zentrum der Inneren Medizin

location_facility: University of Oklahoma Health Sciences Center


title: Prospective Registry on User Experience With The Mapping System For Ablation Procedures

acronym: TRUE-HD

summary: This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Boston Scientific Corporation

location_country:
United States
Hong Kong
Netherlands
France
Australia
Spain
Germany
United Kingdom

location_facility: Strong Memorial Hospital of the University of Rochester


title: A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands

acronym: MPOWERED

summary:
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref).

The purpose of this study is to compare the efficacy safety and patient reported outcomes between oral octreotide capsules and injectable somatostatin analogs.

status: Unknown status

ReferenceType: background

ReferenceCitation: Melmed S, Popovic V, Bidlingmaier M, Mercado M, van der Lely AJ, Biermasz N, Bolanowski M, Coculescu M, Schopohl J, Racz K, Glaser B, Goth M, Greenman Y, Trainer P, Mezosi E, Shimon I, Giustina A, Korbonits M, Bronstein MD, Kleinberg D, Teichman S, Gliko-Kabir I, Mamluk R, Haviv A, Strasburger C. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. J Clin Endocrinol Metab. 2015 Apr;100(4):1699-708. doi: 10.1210/jc.2014-4113. Epub 2015 Feb 9. Erratum in: J Clin Endocrinol Metab. 2016 Oct;101(10 ):3863. J Clin Endocrinol Metab. 2020 Dec 1;105(12):.

ReferenceCitation: Melmed S. New therapeutic agents for acromegaly. Nat Rev Endocrinol. 2016 Feb;12(2):90-8. doi: 10.1038/nrendo.2015.196. Epub 2015 Nov 27. Review.

lead_sponsor: Chiasma, Inc.

location_country:
Italy
Austria
Serbia
Germany
France
Poland
Lithuania
Romania
Hungary
Russian Federation
Spain
United States
United Kingdom

location_facility: Università di Pisa Dipartimento di Medicina Clinica e Sperimentale

location_facility: Fondazione Policlinico Universitario A. Gemelli Università Cattolica del S.Cuore S.C. Endocrinologia e Malattie del Metabolismo

location_facility: Interregional Clinical Diagnostic Center

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami

location_facility: John H. Stroger, Jr. Hospital of Cook County

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

location_facility: Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia

location_facility: Washington University School of Medicine

location_facility: Vladimirsky Moscow Regional Research Clinical Institute

location_facility: Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation

location_facility: Praxis für Endokrinologie und Diabetologie Dr M Droste

location_facility: Antrium Multidisciplinary Medical Clinic

location_facility: Campus Del Hospital Universitario Virgen del Rocio

location_facility: Szegedi Tudományegyetem, I. Belgyógyászati Klinika

location_facility: Clinical Centre of Serbia, Clinic for Endocrinology Diabetes and Metabolic Diseases

location_facility: "C.I. Parhon" National Institute of Endocrinology I Clinical Endocrinology Department - Endemic goitier and its complications

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Sechenov Moscow First State Medical University

location_facility: Regional State Budgetary Healthcare Institution Regional State Hospital

location_facility: The Ohio State University Wexner Medical Center

location_facility: Katedra i Klinika Endokrynologii i Chorob Wewnetrznych Gdanski Uniwersytet Medyczny

location_facility: Central Manchester University Hospitals NHS Foundation Trust, Manchester Royal Infirmary

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Universitätsklinik für Innere Medizin Klinische Abteilung für Endokrinologie und Diabetologie

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Keck Medical Center of University of Southern California

location_facility: Rutgers - Robert Wood Johnson Medical School


title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

acronym: SELECT-NEXT

summary: The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.

ReferenceCitation: Burmester GR, Kremer JM, Van den Bosch F, Kivitz A, Bessette L, Li Y, Zhou Y, Othman AA, Pangan AL, Camp HS. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.

ReferenceCitation: Bergman M, Tundia N, Yang M, Orvis E, Clewell J, Bensimon A. Economic Benefit from Improvements in Quality of Life with Upadacitinib: Comparisons with Tofacitinib and Methotrexate in Patients with Rheumatoid Arthritis. Adv Ther. 2021 Dec;38(12):5649-5661. doi: 10.1007/s12325-021-01930-4. Epub 2021 Oct 12.

family: Bergman

full_name: Martin Bergman

given: Martin

family: Tundia

full_name: Namita Tundia

given: Namita

family: Yang

full_name: Min Yang

given: Min

family: Orvis

full_name: Eli Orvis

given: Eli

family: Clewell

full_name: Jerry Clewell

given: Jerry

family: Bensimon

full_name: Arielle Bensimon

given: Arielle

journal_name: Advances in Therapy

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.

family: Yamaoka

full_name: Kunihiro Yamaoka

given: Kunihiro

family: Tanaka

full_name: Yoshiya Tanaka

given: Yoshiya

family: Kameda

full_name: Hideto Kameda

given: Hideto

family: Khan

full_name: Nasser Khan

given: Nasser

family: Sasaki

full_name: Nobuhito Sasaki

given: Nobuhito

family: Harigai

full_name: Masayoshi Harigai

given: Masayoshi

family: Song

full_name: Yanna Song

given: Yanna

family: Zhang

full_name: Ying Zhang

given: Ying

family: Takeuchi

full_name: Tsutomu Takeuchi

given: Tsutomu

journal_name: Drug Safety

oa_colors: green hybrid

ReferenceCitation: Cohen SB, van Vollenhoven RF, Winthrop KL, Zerbini CAF, Tanaka Y, Bessette L, Zhang Y, Khan N, Hendrickson B, Enejosa JV, Burmester GR. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2020 Oct 28. pii: annrheumdis-2020-218510. doi: 10.1136/annrheumdis-2020-218510. [Epub ahead of print] Erratum in: Ann Rheum Dis. 2021 May;80(5):e83.

ReferenceCitation: Strand V, Pope J, Tundia N, Friedman A, Camp HS, Pangan A, Ganguli A, Fuldeore M, Goldschmidt D, Schiff M. Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT. Arthritis Res Ther. 2019 Dec 9;21(1):272. doi: 10.1186/s13075-019-2037-1. Erratum in: Arthritis Res Ther. 2020 Jun 9;22(1):137.

ReferenceCitation: Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.

name: Clinical Pharmacology and Pharmacometrics AbbVie North Chicago Illinois USA

name: Clinical Pharmacology and Pharmacometrics AbbVie Deutschland GmbH & Co. KG Ludwigshafen am Rhein Germany

name: Immunology Clinical Development AbbVie North Chicago Illinois USA

title: Exposure–Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit–Risk Assessment in Rheumatoid Arthritis

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 and 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:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
Spain
Croatia
France
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Hong Kong
Switzerland
Bulgaria
Hungary
Ireland
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Mexico
Czechia
New Zealand
Kazakhstan
Estonia
Latvia

location_facility: East Tallinn Central Hospital /ID# 140618

location_facility: Center of Clinical and Basic Research /ID# 141116

location_facility: Klinicki bolnicki centar Rijeka /ID# 138649

location_facility: CHRU Tours - Hopital Trousseau /ID# 138969

location_facility: AZ Arthritis and Rheum Researc /ID# 138500

location_facility: Centro Hospitalar Lisboa Ocidental, EPE /ID# 140594

location_facility: Ankara Numune Training and Res /ID# 139237

location_facility: Diag Consult Ctr 17 Sofia EOOD /ID# 141006

location_facility: Clinical Res of West FL, Inc. /ID# 138854

location_facility: Optimus Clinical Research Pty. /ID# 138769

location_facility: Taipei Veterans General Hosp /ID# 139234

location_facility: Revita Reumatologiai Rendelo /ID# 140761

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 138689

location_facility: Aurora Rheumatology and Immunotherapy Center /ID# 139306

location_facility: University of Arizona Cancer Center - North Campus /ID# 140451

location_facility: Narodny ustav reumatickych chorob Piestany /ID# 138427

location_facility: Hosp Nuestra Senora Esperanza /ID# 138997

location_facility: Pacific Arthritis Ctr Med Grp /ID# 138744

location_facility: Chonnam National University Hospital /ID# 138651

location_facility: China Medical University Hosp /ID# 139232

location_facility: South Karelia Central Hospital /ID# 139973

location_facility: Instituto Portugues De Reumatologia /ID# 148315

location_facility: Kazan State Medical University /ID# 138413

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 139052

location_facility: St Vincent's University Hosp /ID# 138562

location_facility: NZOZ Centrum Reumatologiczne /ID# 138353

location_facility: Winelands Medical Research Ctr /ID# 138944

location_facility: JSC Nat Scientific Med Res Ctr /ID# 140575

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 140869

location_facility: Cath Univ Seoul St Mary's Hosp /ID# 138652

location_facility: Spitalul Clinic Judetean de Urgenta /ID# 138407

location_facility: Helsinki Univ Central Hospital /ID# 140381

location_facility: Wilhelminenspital der Stadt Wien /ID# 138788

location_facility: Mautalen Salud e Investigacion /ID# 141419

location_facility: Unidad de Investigacion de las Enfermedades Reumatologicas SA de CV /ID# 138841

location_facility: Far Eastern Memorial Hospital /ID# 140871

location_facility: Bluegrass Community Research /ID# 138295

location_facility: Accurate Clinical Management /ID# 139338

location_facility: MNCE "Lviv City Clinical Hospital #4" /ID# 139873

location_facility: HFR Fribourg - Hopital Canton /ID# 139155

location_facility: The Center for Rheumatology & /ID# 139203

location_facility: Western Washington Arthritis C /ID# 138728

location_facility: University Clinical Centre of the Republic of Srpska /ID# 140372

location_facility: Daegu Catholic University Med /ID# 139249

location_facility: Slovak research center Team Member, Thermium s.r.o. /ID# 139924

location_facility: Deerbrook Medical Associates /ID# 139694

location_facility: Diagnostic Consultative Center /ID# 138882

location_facility: PMG Research of Wilmington LLC /ID# 140951

location_facility: Medallion Clinical Research Institute, LLC /ID# 140074

location_facility: Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 141021

location_facility: School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 139328

location_facility: Cincinnati Rheumatic Disease Study Group, Inc. /ID# 138868

location_facility: Clinical Investigation Special /ID# 139696

location_facility: Centro Peninsular de Investigación Clínica SCP /ID# 148160

location_facility: Hospital General Univ de Elche /ID# 138991

location_facility: University General Hospital of Heraklion "PA.G.N.I" /ID# 139115

location_facility: Hanyang University Seoul Hospi /ID# 138655

location_facility: AZ Arthritis and Rheum Assoc /ID# 148651

location_facility: SunValley Arthritis Center, Lt /ID# 140452

location_facility: Odessa National Medical Univ /ID# 139179

location_facility: Yaroslavi State Medical Univer /ID# 139908

location_facility: Chungnam National University Hospital /ID# 138653

location_facility: Arthritis Clinical Research Tr /ID# 138945

location_facility: Physician Res. Collaboration /ID# 138533

location_facility: Voronezh State Medical Univers /ID# 148431

location_facility: Seoul National University Hospital /ID# 138659

location_facility: Inland Rheum Clin Trials Inc. /ID# 138853

location_facility: St. Augustine's Medical Centre /ID# 141352

location_facility: University Clinical Centre of the Republic of Srpska /ID# 138819

location_facility: Arth and Osteo Clin Brazo Valley /ID# 147809

location_facility: Houston Institute for Clin Res /ID# 138716

location_facility: Arizona Research Center, Inc. /ID# 140448

location_facility: Arthritis & Osteoporosis Clinic /ID# 138703

location_facility: Inst. Rheumatologic Strusberg /ID# 145648

location_facility: Republican Clin Hos n.a. Baran /ID# 139273

location_facility: Southampton General Hospital /ID# 139169

location_facility: Groupe de Recherche en Maladies Osseuses /ID# 138906

location_facility: AZ Arthritis & Rheuma Research /ID# 138598

location_facility: Universita di Catanzaro Magna Graecia /ID# 139316

location_facility: Four Rivers Clinical Research /ID# 141134

location_facility: Spitalul Clinic Judetean de Ur /ID# 138393

location_facility: Klaipeda University Hospital /ID# 141416

location_facility: Ctr Arthritis & Rheumatic Dise /ID# 141696

location_facility: Hospital Clin Univ San Carlos /ID# 138993

location_facility: Fejer Megyei Szent Gyorgy Korh /ID# 138554

location_facility: National Cheng Kung University Hospital /ID# 140868

location_facility: Samara Regional Clinical Hosp /ID# 148642

location_facility: Ulyanovsk Regional Clin Hosp /ID# 139279

location_facility: Warrington + Halton Hosp NHS /ID# 139195

location_facility: AZ Arthritis and Rheum Researc /ID# 139286

location_facility: Trinity Universal Research Association /ID# 148649

location_facility: Rheuma Zentrum Favoriten GmbH /ID# 138787


type: Other Grant/Funding Number

title: A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors

summary: This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of Durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in Adult Subjects with selected advanced solid tumors and the combination of durvalumab and monalizumab (IPH2201) standard of care systemic therapy with or without biological agent and monalizumab (IPH2201) with biological agent administered to subjects with recurrent or metastatic colorectal cancer (CRC).

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

lead_sponsor: MedImmune LLC

location_country:
Italy
United States
France
Hungary
Belgium
Australia
New Zealand
Spain
Canada
United Kingdom
Korea, Republic of

intervention_type: Combination Product


title: A Phase 1/1b, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activity of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Combination With the PARP Inhibitor BGB-290 in Subjects With Advanced Solid Tumors

summary: This trial studied the safety, pharmacokinetics, and antitumor activity of the anti-programmed cell death 1 (PD-1) monoclonal antibody (mAb) BGB-A317 (tislelizumab) in combination with the poly(adenosine diphosphate ribose) polymerase (PARP) inhibitor BGB-290 (pamiparib) in participants with advanced solid tumors.

ReferenceType: result

ReferenceCitation: Friedlander M, Meniawy T, Markman B, Mileshkin L, Harnett P, Millward M, Lundy J, Freimund A, Norris C, Mu S, Wu J, Paton V, Gao B. Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-escalation stage of a multicentre, open-label, phase 1a/b trial. Lancet Oncol. 2019 Sep;20(9):1306-1315. doi: 10.1016/S1470-2045(19)30396-1. Epub 2019 Aug 1.

family: Friedlander

full_name: Michael Friedlander

given: Michael

family: Meniawy

full_name: Tarek Meniawy

given: Tarek

family: Markman

full_name: Ben Markman

given: Ben

family: Mileshkin

full_name: Linda Mileshkin

given: Linda

family: Harnett

full_name: Paul Harnett

given: Paul

family: Millward

full_name: Michael Millward

family: Lundy

full_name: Joanne Lundy

given: Joanne

family: Freimund

full_name: Alison Freimund

given: Alison

family: Norris

full_name: Christie Norris

given: Christie

family: Mu

full_name: Song Mu

given: Song

family: Wu

full_name: John Wu

given: John

family: Paton

full_name: Virginia Paton

given: Virginia

family: Gao

full_name: Bo Gao

given: Bo

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: BeiGene

location_country:
France
Australia
New Zealand
Spain
United States
United Kingdom

location_facility: Hospital Clínico Universitario de Valencia


title: An Open-Label, Multicenter, Dose Escalation and Expansion Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors

summary: This is an open-label, multicenter, dose-escalation and expansion Phase Ib clinical study of RO6958688 in combination with atezolizumab. Part I of the study is subdivided into parts IA and IB. Part IA is dose escalation with a starting dose of 5 mg of RO6958688 given QW (once a week) and a fixed, flat dose of 1200 mg given Q3W (every 3 weeks) of atezolizumab, to evaluate the safety and determine the MTD of RO6958688 in combination with atezolizumab. Part IB is a dose/schedule finding part that will explore different administration schedules of RO6958688 in combination with atezolizumab (1200 mg Q3W) to establish the appropriate dose/schedule of RO6958688 in combination with atezolizumab.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Netherlands
France
Spain
Denmark
United States
Canada

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Antoni Van Leeuwenhoek Ziekenhuis; Gastro-Enterologie

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: IRCCS IST. Tumori Fondaz. Pascale; S.C. Oncologia Medica,Melanoma,Immunoterapia E Terapie Innovative

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz

location_facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

location_facility: Smilow Cancer Hospital at Yale- New Haven Oncology Investigational Drug Pharmacy


title: RAINBOW Extension Study: an Extension Study to Evaluate the Long Term Efficacy and Safety of RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

acronym: RainbowExt

summary: The purpose of this study is to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301

ReferenceCitation: Marlow N, Stahl A, Lepore D, Fielder A, Reynolds JD, Zhu Q, Weisberger A, Stiehl DP, Fleck B; RAINBOW investigators group. 2-year outcomes of ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW extension study): prospective follow-up of an open label, randomised controlled trial. Lancet Child Adolesc Health. 2021 Oct;5(10):698-707. doi: 10.1016/S2352-4642(21)00195-4. Epub 2021 Aug 13.

family: Marlow

full_name: Neil Marlow

given: Neil

family: Stahl

full_name: Andreas Stahl

given: Andreas

family: Lepore

full_name: Domenico Lepore

given: Domenico

family: Fielder

full_name: Alistair Fielder

given: Alistair

family: Reynolds

full_name: James D Reynolds

given: James D

family: Zhu

full_name: Qi Zhu

given: Qi

family: Weisberger

full_name: Annemarie Weisberger

given: Annemarie

family: Stiehl

full_name: Daniel P Stiehl

given: Daniel P

family: Fleck

full_name: Brian Fleck

given: Brian

journal_name: The Lancet Child & Adolescent Health

ipd_sharing: Undecided

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Malaysia
Greece
Romania
Belgium
Russian Federation
Denmark
Taiwan
India
Croatia
France
Japan
Lithuania
Slovakia
Turkey
Saudi Arabia
Hungary
Germany
United States
United Kingdom
Italy
Austria
Czechia
Egypt
Estonia


ReferenceCitation: Bebb DG, Banerji S, Blais N, Desmeules P, Gill S, Grin A, Feilotter H, Hansen AR, Hyrcza M, Krzyzanowska M, Melosky B, Noujaim J, Purgina B, Ruether D, Simmons CE, Soulieres D, Torlakovic EE, Tsao MS. Canadian Consensus for Biomarker Testing and Treatment of TRK Fusion Cancer in Adults. Curr Oncol. 2021 Jan 15;28(1):523-548. doi: 10.3390/curroncol28010053.

family: Bebb

full_name: D. Gwyn Bebb

given: D. Gwyn

family: Banerji

full_name: Shantanu Banerji

given: Shantanu

family: Blais

full_name: Normand Blais

given: Normand

family: Desmeules

full_name: Patrice Desmeules

given: Patrice

family: Gill

full_name: Sharlene Gill

given: Sharlene

family: Grin

full_name: Andrea Grin

given: Andrea

family: Feilotter

full_name: Harriet Feilotter

given: Harriet

family: Hansen

full_name: Aaron R. Hansen

given: Aaron R.

family: Hyrcza

full_name: Martin Hyrcza

given: Martin

family: Krzyzanowska

full_name: Monika Krzyzanowska

given: Monika

family: Melosky

full_name: Barbara Melosky

given: Barbara

family: Noujaim

full_name: Jonathan Noujaim

given: Jonathan

family: Purgina

full_name: Bibiana Purgina

given: Bibiana

family: Ruether

full_name: Dean Ruether

given: Dean

family: Simmons

full_name: Christine E. Simmons

given: Christine E.

family: Soulieres

full_name: Denis Soulieres

given: Denis

family: Torlakovic

full_name: Emina Emilia Torlakovic

given: Emina Emilia

family: Tsao

full_name: Ming-Sound Tsao

given: Ming-Sound

currency_apc_doaj: CHF

journal_name: Current Oncology

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI

ReferenceCitation: Perreault S, Chami R, Deyell RJ, El Demellawy D, Ellezam B, Jabado N, Morgenstern DA, Narendran A, Sorensen PHB, Wasserman JD, Yip S. Canadian Consensus for Biomarker Testing and Treatment of TRK Fusion Cancer in Pediatric Patients. Curr Oncol. 2021 Jan 9;28(1):346-366. doi: 10.3390/curroncol28010038.

family: Perreault

full_name: Sébastien Perreault

given: Sébastien

ReferenceCitation: Bielack SS, Cox MC, Nathrath M, Apel K, Blattmann C, Holl T, Jenewein R, Klenk U, Klothaki P, Müller-Abt P, Ortega-Lawerenz S, Reynolds M, Scheer M, Simon-Klingenstein K, Stegmaier S, Tupper R, Vokuhl C, von Kalle T. Rapid, complete and sustained tumour response to the TRK inhibitor larotrectinib in an infant with recurrent, chemotherapy-refractory infantile fibrosarcoma carrying the characteristic ETV6-NTRK3 gene fusion. Ann Oncol. 2019 Nov;30 Suppl 8:viii31-viii35. doi: 10.1093/annonc/mdz382. Epub 2019 Dec 24.

ReferenceCitation: Hong DS, DuBois SG, Kummar S, Farago AF, Albert CM, Rohrberg KS, van Tilburg CM, Nagasubramanian R, Berlin JD, Federman N, Mascarenhas L, Geoerger B, Dowlati A, Pappo AS, Bielack S, Doz F, McDermott R, Patel JD, Schilder RJ, Tahara M, Pfister SM, Witt O, Ladanyi M, Rudzinski ER, Nanda S, Childs BH, Laetsch TW, Hyman DM, Drilon A. Larotrectinib in patients with TRK fusion-positive solid tumours: a pooled analysis of three phase 1/2 clinical trials. Lancet Oncol. 2020 Apr;21(4):531-540. doi: 10.1016/S1470-2045(19)30856-3. Epub 2020 Feb 24.

ReferenceCitation: Bielack SS, Cox MC, Nathrath M, Apel K, Blattmann C, Holl T, Jenewein R, Klenk U, Klothaki P, Müller-Abt P, Ortega-Lawerenz S, Reynolds M, Scheer M, Simon-Klingenstein K, Stegmaier S, Tupper R, Vokuhl C, von Kalle T. Rapid, complete and sustained tumour response to the TRK inhibitor larotrectinib in an infant with recurrent, chemotherapy-refractory infantile fibrosarcoma carrying the characteristic ETV6-NTRK3 gene fusion. Ann Oncol. 2019 Nov 1;30(Suppl_8):viii31-viii35. doi: 10.1093/annonc/mdz382.

ReferenceCitation: DuBois SG, Laetsch TW, Federman N, Turpin BK, Albert CM, Nagasubramanian R, Anderson ME, Davis JL, Qamoos HE, Reynolds ME, Cruickshank S, Cox MC, Hawkins DS, Mascarenhas L, Pappo AS. The use of neoadjuvant larotrectinib in the management of children with locally advanced TRK fusion sarcomas. Cancer. 2018 Nov 1;124(21):4241-4247. doi: 10.1002/cncr.31701. Epub 2018 Sep 11.

name: Pediatric Hematology/Oncology, Dana-Farber/Boston Children’s Cancer and Blood Disorders Center; Harvard Medical School; Boston Massachusetts

name: Department of Pediatrics; University of Texas Southwestern Medical Center/Children’s Health; Dallas Texas

name: Department of Pediatrics; University of California at Los Angeles; Los Angeles California

name: Cancer and Blood Diseases Institute; Cincinnati Children’s Hospital Medical Center; Cincinnati Ohio

name: Department of Pediatrics, Seattle Children’s Hospital, Fred Hutchinson Cancer Research Center; University of Washington; Seattle Washington

name: Department of Pediatrics; Nemours Children’s Hospital; Orlando Florida

name: Department of Orthopedic Surgery; Boston Children’s Hospital, Harvard Medical School; Boston Massachusetts

name: Department of Pathology; Oregon Health and Science University; Portland Oregon

name: Loxo Oncology Inc; South San Francisco California

name: Department of Pediatrics, Children’s Hospital Los Angeles, Keck School of Medicine; University of Southern California; Los Angeles California

name: Department of Oncology; St Jude Children’s Research Hospital; Memphis Tennessee

ReferenceCitation: Laetsch TW, DuBois SG, Mascarenhas L, Turpin B, Federman N, Albert CM, Nagasubramanian R, Davis JL, Rudzinski E, Feraco AM, Tuch BB, Ebata KT, Reynolds M, Smith S, Cruickshank S, Cox MC, Pappo AS, Hawkins DS. Larotrectinib for paediatric solid tumours harbouring NTRK gene fusions: phase 1 results from a multicentre, open-label, phase 1/2 study. Lancet Oncol. 2018 May;19(5):705-714. doi: 10.1016/S1470-2045(18)30119-0. Epub 2018 Mar 29. Erratum in: Lancet Oncol. 2018 May;19(5):e229.

ReferenceCitation: Drilon A, Laetsch TW, Kummar S, DuBois SG, Lassen UN, Demetri GD, Nathenson M, Doebele RC, Farago AF, Pappo AS, Turpin B, Dowlati A, Brose MS, Mascarenhas L, Federman N, Berlin J, El-Deiry WS, Baik C, Deeken J, Boni V, Nagasubramanian R, Taylor M, Rudzinski ER, Meric-Bernstam F, Sohal DPS, Ma PC, Raez LE, Hechtman JF, Benayed R, Ladanyi M, Tuch BB, Ebata K, Cruickshank S, Ku NC, Cox MC, Hawkins DS, Hong DS, Hyman DM. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. N Engl J Med. 2018 Feb 22;378(8):731-739. doi: 10.1056/NEJMoa1714448.

name: From Memorial Sloan Kettering Cancer Center (A. Drilon, J.F.H., R.B., M.L., D.M.H.) and Weill Cornell Medical College (A. Drilon, D.M.H.), New York; University of Texas Southwestern Medical Center–Children’s Health, Dallas (T.W.L.); Stanford Cancer Center, Stanford University, Palo Alto (S.K.), Children’s Hospital Los Angeles, Keck School of Medicine, University of Southern California (L.M.), and UCLA David Geffen School of Medicine (N.F.), Los Angeles, and Loxo Oncology, South San Francisco (B.B.T., K.E...

title: Efficacy of Larotrectinib inTRKFusion–Positive Cancers in Adults and Children

ipd_sharing_description:
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Australia
Russian Federation
Denmark
Ukraine
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Ireland
China
United States
Germany
United Kingdom
Italy
Czechia
Israel
Spain
Turkey

location_facility: Western Ukrainian Specialized Pediatric Medical Centre

location_facility: The Hospital for Sick Children (SickKids)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Lucille Salter Packard Children's Hospital at Stanford

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Osaka City Hospital Organization Osaka City General Hospital

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Center of Pediatric Hematology, Oncology and Immunology

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Karolinska Universitetssjukhuset i Solna

location_facility: Clalit Health Services Schneider Children's Medical Center

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Beijing Children's Hospital, Capital Medical University

location_facility: Cincinnati Children's Hospital and Medical Center

location_facility: Tianjin Medical University Cancer Institiute & Hospital

title: A Phase 1/2 Study of the Oral TRK Inhibitor LOXO-101 in Pediatric Patients With Advanced Solid or Primary Central Nervous System Tumors

summary:
The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.


title: A Prospective, 5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures for the Treatment of the Degenerative Lumbar Spine

summary:
The purpose of this study is

to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I).
To assess how single or double level MAST(Minimal Access Spinal Technologies) fusion procedures PLIF (Posterior Lumbar Interbody Fusion), TLIF (Transforaminal Lumbar Interbody Fusion), DLIF (Direct Lateral Interbody Fusion), OLIF (Oblique Lumbar Interbody Fusion), ALIF (Anterior Lumbar Interbody Fusion), or MIDLF (Midline Lumbar Interbody Fusion) are used in surgical practice and to describe long-term safety and effectiveness in a broad patient population of patients with degenerative lumbar disc disease .

lead_sponsor: Medtronic Spinal and Biologics

location_country:
Italy
Austria
Brazil
Mexico
Spain
France
Czechia
Slovakia
Argentina
Belgium
Russian Federation
China
Denmark
Germany
United Kingdom
Korea, Republic of
Portugal

location_facility: Department of Orthopedics, Korea University Ansan Hospital

location_facility: East Suffolk and North Essex NHS Foundation Trust (was formerly Ipswich Hospital NHS)

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Department of Neurological Surgery, Chung-Ang University Hospital

location_facility: National Health Insurance Corporation Ilsan Hospital

location_facility: Scientific Research Institute of Traumatology and Orthopedics

location_facility: The First Affiliated Hospital of Dalian Medical University

location_facility: Hospital Naval General de Alta Especialidad

location_facility: Nizhny Novgorod Research Institute of Traumatology and Orthopedics of Public Health Ministry


title: Methodology Study of Novel Electrophysiological, Physical, and Imaging Outcome Measures to Assess the Progression of Amyotrophic Lateral Sclerosis

summary: The primary objectives of the study are to estimate and rank-order the longitudinal standardized mean changes over 6 months and over 12 months, for a set of outcome measures administered to participants with amyotrophic lateral sclerosis (ALS), in order to identify measures that are more sensitive to disease progression than Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R). The secondary objectives of this study are: To evaluate the test-retest reproducibility of each outcome measure; To determine correlations between 6 and 12-month changes in all exploratory measures with 18 and 24-month changes in ALSFRS-R and survival; To assess correlations between/among the various measures; To obtain biological samples in order to identify molecular correlates to the clinical measures and to further characterize previously identified and novel molecular biomarkers of disease progression for incorporation into future clinical studies.

lead_sponsor: Biogen

location_country:
United States
Switzerland
Netherlands
Germany
France
Ireland
Belgium
Canada
United Kingdom

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hopital Gui de Chauliac, Service de Neurologie

location_facility: University of California San Diego Medical Center

location_facility: Washington University School of Medicine

location_facility: Montreal Neurological Institute Clinical Research Unit


title: A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma

summary:
This is a Phase I, open-label, dose escalation and dose expansion study with BID (suspension) and TID (tablet) oral dose of tazemetostat. Subjects will be screened for eligibility within 14 days of the planned first dose of tazemetostat. A treatment cycle will be 28 days. Response assessment will be evaluated after 8 weeks of treatment and subsequently every 8 weeks while on study.

The study has two parts: Dose Escalation and Dose Expansion.

Dose escalation for subjects with the following relapsed/refractory malignancies:

Rhabdoid tumors:
Atypical teratoid rhabdoid tumor (ATRT)
Malignant rhabdoid tumor (MRT)
Rhabdoid tumor of kidney (RTK)
Selected tumors with rhabdoid features
INI1-negative tumors:
Epithelioid sarcoma
Epithelioid malignant peripheral nerve sheath tumor
Extraskeletal myxoid chondrosarcoma
Myoepithelial carcinoma
Renal medullary carcinoma
Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) (with Sponsor approval)
Synovial Sarcoma with a SS18-SSX rearrangement Dose Escalation cohorts are closed to enrollment.

Dose Expansion at the MTD or the RP2D

Cohort 1 - ATRT (closed to enrollment)
Cohort 2 - MRT/RTK/selected tumors with rhabdoid features (closed to enrollment)

Cohort 3 - INI-negative tumors:

Epithelioid sarcoma
Epithelioid malignant peripheral nerve sheath tumor
Extraskeletal myxoid chondrosarcoma
Myoepithelial carcinoma
Renal medullary carcinoma
Chordoma (poorly differentiated or de-differentiated)
Other INI1-negative malignant tumors (e.g., dedifferentiated chordoma) with Sponsor approval
Cohort 4 - Tumor types eligible for Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement (closed to enrollment)

lead_sponsor: Epizyme, Inc.

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

location_facility: The Childrens Hospital at Westmead Oncology Unit

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Istituto Giannina Gaslini- UOSD Centro di Neuro-Oncologia

location_facility: Ann and Robert H. Lurie Children's Hospital of Chicago

location_facility: St. Jude Children's Research Hospital, Inc.

location_facility: Massachusetts General Hospital - Cancer Center

location_facility: University of California San Francisco - Benioff Children's Hospital

location_facility: Lady Cilento/Queensland Children's Hospital

location_facility: Erasmus University Medical Center - Sophia Children's Hospital

location_facility: Texas Children's Cancer and Hematology Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Oregon Health & Science University (OHSU)

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust

location_facility: Westfalische Wilhelms - Universitat Munster Padiatrische

location_facility: Central Manchester University Hospital - Royal Manchester Children's Hospital

location_facility: Prinses Maxima Centrum voor Kinderoncologie

location_facility: Rigshospitalet Department of Oncology Blegdamsvej


title: A Randomized, Actively Controlled, Open-label, Multicenter Study of Efficacy and Safety of Evolocumab Compared With Low Density Lipoprotein Cholesterol (LDL-C) Apheresis, Followed by Single-Arm Evolocumab Administration in Subjects Receiving LDL-C Apheresis Prior to Study Enrollment

summary: To evaluate the efficacy of subcutaneous (SC) evolocumab, compared to regularly scheduled low-density lipoprotein cholesterol (LDL-C) apheresis, on reducing the need for future apheresis.

lead_sponsor: Amgen

location_country:
Italy
United States
France
Czechia
Australia
Spain
Germany
United Kingdom


lead_sponsor: Bayer

location_country:
Italy
Austria
Switzerland
Spain
Germany
France
Czechia
Lithuania
Poland
Slovakia
Hungary
Portugal
Canada
United Kingdom

acronym: AQUA

title: Open-label Phase-4 Study to Examine the Change of Vision-related Quality of Life in Subjects With Diabetic Macular Edema (DME) During Treatment With Intravitreal Injections of 2 mg Aflibercept According to EU Label for the First Year of Treatment

summary: To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU Label.


ReferenceCitation: Mitchell P, Holz FG, Hykin P, Midena E, Souied E, Allmeier H, Lambrou G, Schmelter T, Wolf S; ARIES study investigators. EFFICACY AND SAFETY OF INTRAVITREAL AFLIBERCEPT USING A TREAT-AND-EXTEND REGIMEN FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: The ARIES Study: A Randomized Clinical Trial. Retina. 2021 Sep 1;41(9):1911-1920. doi: 10.1097/IAE.0000000000003128.

family: Mitchell

full_name: Paul Mitchell

given: Paul

family: Holz

full_name: Frank G. Holz

given: Frank G.

family: Hykin

full_name: Philip Hykin

given: Philip

family: Midena

full_name: Edoardo Midena

given: Edoardo

family: Souied

full_name: Eric Souied

given: Eric

family: Allmeier

full_name: Helmut Allmeier

given: Helmut

family: Lambrou

full_name: George Lambrou

given: George

family: Schmelter

full_name: Thomas Schmelter

given: Thomas

family: Wolf

full_name: Sebastian Wolf

given: Sebastian

name: on behalf of the ARIES study investigators

journal_name: Retina

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

location_country:
Italy
France
Hungary
Australia
Spain
Germany
United Kingdom
Canada

acronym: ARIES

title: Managing Neovascular Age-related Macular Degeneration (nAMD) Over 2 Years With a Treat and Extend (T&E) Regimen of 2 mg Intravitreal Aflibercept - a Randomized, Open-label, Active-controlled, Parallel-group Phase IV/IIIb Study (ARIES)

summary: This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.


ReferenceCitation: Zinzani PL, Santoro A, Gritti G, Brice P, Barr PM, Kuruvilla J, Cunningham D, Kline J, Johnson NA, Mehta-Shah N, Manley T, Francis S, Sharma M, Moskowitz AJ. Nivolumab Combined With Brentuximab Vedotin for Relapsed/Refractory Primary Mediastinal Large B-Cell Lymphoma: Efficacy and Safety From the Phase II CheckMate 436 Study. J Clin Oncol. 2019 Nov 20;37(33):3081-3089. doi: 10.1200/JCO.19.01492. Epub 2019 Aug 9.

name: Institute of Hematology “Seràgnoli” Bologna University, Bologna, Italy

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

name: IRCCS Humanitas Research Hospital, Humanitas University, Milan, Italy

family: Santoro

full_name: Armando Santoro

given: Armando

name: Ospedale Papa Giovanni XXIII, Bergamo, Italy

family: Gritti

full_name: Giuseppe Gritti

given: Giuseppe

family: Brice

full_name: Pauline Brice

given: Pauline

family: Barr

full_name: Paul M. Barr

given: Paul M.

name: Princess Margaret Cancer Centre, Toronto, Ontario, Canada

family: Kuruvilla

full_name: John Kuruvilla

given: John

name: Royal Marsden Hospital, London, United Kingdom

family: Cunningham

full_name: David Cunningham

given: David

family: Kline

full_name: Justin Kline

given: Justin

name: Jewish General Hospital, Montreal, Québec, Canada

family: Johnson

full_name: Nathalie A. Johnson

given: Nathalie A.

name: Washington University in St. Louis, St. Louis, MO

family: Mehta-Shah

full_name: Neha Mehta-Shah

given: Neha

family: Manley

full_name: Thomas Manley

family: Francis

full_name: Stephen Francis

given: Stephen

family: Sharma

full_name: Manish Sharma

given: Manish

name: Memorial Sloan Kettering Cancer Center, New York, NY

family: Moskowitz

full_name: Alison J. Moskowitz

given: Alison J.

journal_name: Journal of Clinical Oncology

oa_host_type: repository

publisher: American Society of Clinical Oncology (ASCO)

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
France
Spain
United States
United Kingdom
Canada

acronym: CheckMate 436

location_facility: Alma Mater Studiorum - Universita' Di Bologna

location_facility: U of Washington / Seattle Cancer Care Alliance

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Washington University School Of Medicine

location_facility: University Of Miami Sylvester Comprehensive Cancer Center

title: A Phase I/ II Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab in Combination With Brentuximab Vedotin in Subjects With Relapsed Refractory Non Hodgkin Lymphomas With CD30 Expression (CheckMate 436: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 436)

summary: The purpose of this study is to determine whether Nivolumab, in combination with brentuximab vedotin, is safe and effective in patients with certain subtypes of non-Hodgkin's lymphomas with CD30 expression that have not responded to treatment or have come back. The subtypes we are studying are Diffuse Large B-Cell Lymphoma (DLBCL), Peripheral T-Cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), Primary Mediastinal Large B-Cell Lymphoma (PMBL) and Mediastinal Gray Zone Lymphoma (MGZL).


title: A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects With Rosacea

summary: This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.

lead_sponsor: Maruho Co., Ltd.

location_country:
United States
Sweden
Netherlands
France
Australia
New Zealand
Canada
United Kingdom


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:
United States
France
Japan
Poland
Australia
Canada
United Kingdom
Taiwan

acronym: JAVELIN Medley

location_facility: UCLA Hematology-Oncology Infusion Center

location_facility: PH 145294, Centre Hospitalier de l'Universite de Montreal (CHUM), Oncology Research Pharmacy

location_facility: UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: Investigational Drug Services, National Taiwan University Hospital

location_facility: Sanford Cancer Center Oncology Clinic & Pharmacy

location_facility: University of Pittsburgh Cancer Institute

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Weill Cornell Medical College/New York Presbyterian Hospital

location_facility: Mount Sinai Comprehensive Cancer Center - Aventura

location_facility: British Columbia Cancer Agency - Vancouver Centre

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

location_facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center

location_facility: NYU Laura and Isaac Perlmutter Cancer Center

location_facility: The Sarah Cannon Research Institute / Tennessee Oncology, PLLC

location_facility: University of Texas Southwestern Medical Center

location_facility: UT Southwestern Simmons Comprehensive Cancer Center

location_facility: UCLA Clinical Research Unit (Adminstration Office)

location_facility: Investigational Pharmacy, Karmanos Cancer Center

title: A PHASE 1B/2 OPEN-LABEL STUDY TO EVALUATE SAFETY, CLINICAL ACTIVITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH OTHER CANCER IMMUNOTHERAPIES IN PATIENTS WITH ADVANCED MALIGNANCIES

summary: This is a Phase 1b/2 dose-optimization study to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination with other cancer immunotherapies in patients with locally advanced or metastatic solid tumors. The primary purpose is to assess the safety and early signs of efficacy of various avelumab combinations with other cancer immunotherapies, optimizing dosing regimens as appropriate, in a limited series of indications.


title: A Phase 1b Study to Evaluate the Safety and Efficacy of MEDI4736 as Monotherapy and in Combination With Tremelimumab or AZD9150 in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma.

summary: The purpose of this study is to evaluate the safety, tolerability, and efficacy of MEDI4736 (durvalumab) alone and in combination with either tremelimumab or AZD9150 in adult subjects with relapsed or refractory dIffuse large B-cell lymphoma.

location_country:
United States
Ireland
France
United Kingdom


title: An Open-Label, Single-Arm, Phase 3 Study to Evaluate the Effects of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

summary: The primary objective of this study is to establish the effect of KRN23 treatment on improvement in XLH-associated osteomalacia as determined by osteoid volume (osteoid volume/bone volume, OV/BV).

lead_sponsor: Ultragenyx Pharmaceutical Inc

location_country:
France
Japan
Korea, Republic of
Denmark
United States
Canada

location_facility: Aarhus University Hospital-Dept of Endocrinology and Internal Medicine

location_facility: CHU de Bicêtre, Service d'Endocrinologie et des Maladies de la Reproduction

location_facility: Indiana University Department of Medicine University Hospital

location_facility: Yale University School of Medicine - Yale New-Haven Hospital/Yale Center for Clinical Investigation


title: Phase 1b, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of QR-010 in Subjects With Homozygous ΔF508 Cystic Fibrosis

summary: A randomized, double-blind, placebo-controlled study of single and multiple ascending doses of QR-010 in adults homozygous for ΔF508 Cystic Fibrosis.

ReferenceCitation: Miah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27. Review.

name: Gene Medicine Group, Nuffield Division of Clinical Laboratory Science, Radcliffe Department of Medicine, University of Oxford, Oxford, UK

family: Miah

full_name: Kamran M. Miah

given: Kamran M.

family: Hyde

full_name: Stephen C. Hyde

given: Stephen C.

family: Gill

full_name: Deborah R. Gill

given: Deborah R.

journal_name: Expert Review of Respiratory Medicine

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

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

version: submittedVersion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: ProQR Therapeutics

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

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Washington University School of Medicine

location_facility: University of Southern California USC - Keck School of Medicine

location_facility: University of Calgary (Health Sciences Centre)

location_facility: Munich U. Hospital, Cystic Fibrosis Center for Adults

location_facility: University of Kansas Medical Center Research Institute


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes

summary: This Phase 3 study was designed to demonstrate the net benefit of sotagliflozin versus placebo in patients with Type 1 Diabetes (T1D).

ReferenceCitation: Garg SK, Henry RR, Banks P, Buse JB, Davies MJ, Fulcher GR, Pozzilli P, Gesty-Palmer D, Lapuerta P, Simó R, Danne T, McGuire DK, Kushner JA, Peters A, Strumph P. Effects of Sotagliflozin Added to Insulin in Patients with Type 1 Diabetes. N Engl J Med. 2017 Dec 14;377(24):2337-2348. doi: 10.1056/NEJMoa1708337. Epub 2017 Sep 13.

family: Garg

full_name: Satish K. Garg

given: Satish K.

family: Henry

full_name: Robert R. Henry

given: Robert R.

family: Banks

full_name: Phillip Banks

given: Phillip

family: Buse

full_name: John B. Buse

given: John B.

family: Davies

full_name: Melanie J. Davies

given: Melanie J.

family: Fulcher

full_name: Gregory R. Fulcher

given: Gregory R.

family: Pozzilli

full_name: Paolo Pozzilli

given: Paolo

family: Gesty-Palmer

full_name: Diane Gesty-Palmer

given: Diane

family: Lapuerta

full_name: Pablo Lapuerta

given: Pablo

family: Simó

full_name: Rafael Simó

given: Rafael

family: Danne

full_name: Thomas Danne

given: Thomas

family: McGuire

full_name: Darren K. McGuire

given: Darren K.

family: Kushner

full_name: Jake A. Kushner

given: Jake A.

family: Peters

full_name: Anne Peters

given: Anne

family: Strumph

full_name: Paul Strumph

given: Paul

journal_name: New England Journal of Medicine

evidence: open (via free article)

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repository_institution: University of Leicester - Leicester Research Archive

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

lead_sponsor: Lexicon Pharmaceuticals

location_country:
Italy
South Africa
Spain
Germany
France
Bulgaria
Czechia
Israel
Poland
Slovakia
Hungary
Belgium
Argentina
Australia
New Zealand
United States
United Kingdom
Canada
Colombia


title: Single-Arm Study to Assess the Efficacy of UVADEX® (Methoxsalen) Sterile Solution in Conjunction With the THERAKOS® CELLEX® Photopheresis System in Pediatric Patients With Steroid-Refractory Acute Graft-vs-Host Disease (aGvHD)

summary: This is a single-arm, open-label, multicenter study of the efficacy of UVADEX® (methoxsalen) Sterile Solution in conjunction with THERAKOS® CELLEX® Photopheresis Systems (ECP) in pediatric participants with steroid-refractory aGvHD. The study is composed of Screening, Treatment, and Follow-up Periods.

ipd_sharing_description:
Because we work in the rare disease space, to eliminate risk of patient identification we do not share individual patient data.

We post summary aggregate results for applicable clinical trials in the registry, and statistical endpoints and discussion in publications; with each referencing the other.

lead_sponsor: Therakos, Inc., a Mallinckrodt Company

location_country:
Italy
Austria
Germany
France
Hungary
Spain
United States
United Kingdom

location_facility: Children's Healthcare of Atlanta, Emory - Children's Center

location_facility: U.O.C. Clinica di Oncoematologia Pediatrica Azienda Ospedaliera di Padova

location_facility: Vanderbilt University Medical Center - Ingram Cancer Institute

location_facility: University Hospitals Rainbow Babies & Children's

location_facility: Hospital Infantil Universitario "Nino Jesus"

location_facility: Klinikum rechts der Isar, TU München, Klinik- und Poliklinik für Kinder- und Jugendmedizin, Kinderklinik München Schwabing

location_facility: Universitaetsklinikum Ulm, Kinder- und Jugendmedizin

location_facility: Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin, Abteilung für Hämatologie und Internistische Onkologie


title: A Phase 1 Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors

summary: This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of avapritinib (formerly BLU-285), administered orally (PO), in adult patients with unresectable GIST or other relapsed or refractory solid tumors. The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2).

ReferenceCitation: Kang YK, George S, Jones RL, Rutkowski P, Shen L, Mir O, Patel S, Zhou Y, von Mehren M, Hohenberger P, Villalobos V, Brahmi M, Tap WD, Trent J, Pantaleo MA, Schöffski P, He K, Hew P, Newberry K, Roche M, Heinrich MC, Bauer S. Avapritinib Versus Regorafenib in Locally Advanced Unresectable or Metastatic GI Stromal Tumor: A Randomized, Open-Label Phase III Study. J Clin Oncol. 2021 Oct 1;39(28):3128-3139. doi: 10.1200/JCO.21.00217. Epub 2021 Aug 3.

name: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

family: Kang

full_name: Yoon-Koo Kang

given: Yoon-Koo

name: Department of Medical Oncology, Sarcoma Center, Dana Farber Cancer Institute, Boston, MA

family: George

full_name: Suzanne George

given: Suzanne

name: Royal Marsden Hospital and Institute of Cancer Research, London, UK

family: Jones

full_name: Robin L. Jones

given: Robin L.

name: Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

name: Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China

family: Shen

full_name: Lin Shen

given: Lin

name: Institut Gustave Roussy, Villejuif, France

family: Mir

full_name: Olivier Mir

given: Olivier

name: Department of Sarcoma Medical Oncology, MD Anderson Cancer Center, Houston, TX

family: Patel

full_name: Shreyaskumar Patel

given: Shreyaskumar

name: Fujian Medical University, Fujian, China

family: Zhou

full_name: Yongjian Zhou

given: Yongjian

name: Department of Hematology Oncology, Fox Chase Cancer Center, Philadelphia, PA

family: von Mehren

full_name: Margaret von Mehren

given: Margaret

name: Division of Surgical Oncology and Thoracic Surgery, University of Heidelberg (UMM), Mannheim, Germany

family: Hohenberger

full_name: Peter Hohenberger

given: Peter

name: Division of Medical Oncology, University of Colorado School of Medicine, Aurora, CO

name: Currently at Janssen Oncology, Aurora, CO

family: Villalobos

full_name: Victor Villalobos

given: Victor

family: Brahmi

full_name: Mehdi Brahmi

given: Mehdi

name: Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY

family: Tap

full_name: William D. Tap

given: William D.

name: Department of Medicine, University of Miami-Sylvester Comprehensive Cancer Center, Miami, FL

family: Trent

full_name: Jonathan Trent

given: Jonathan

name: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy

family: Pantaleo

full_name: Maria A. Pantaleo

given: Maria A.

name: Department of General Medicine Oncology, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

name: Blueprint Medicines Corporation, Cambridge, MA

family: He

full_name: Kevin He

given: Kevin

family: Hew

full_name: Paggy Hew

given: Paggy

family: Newberry

full_name: Kate Newberry

given: Kate

family: Roche

full_name: Maria Roche

given: Maria

name: Portland VA Health Care System and OHSU Knight Cancer Institute, Portland, OR

family: Heinrich

full_name: Michael C. Heinrich

given: Michael C.

name: Department of Medical Oncology, Sarcoma Center, West German Cancer Center, DKTK-Partner-Site, University of Duisburg-Essen, Essen, Germany

family: Bauer

full_name: Sebastian Bauer

given: Sebastian

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: von Mehren M, Heinrich MC, Shi H, Iannazzo S, Mankoski R, Dimitrijević S, Hoehn G, Chiroli S, George S. Clinical efficacy comparison of avapritinib with other tyrosine kinase inhibitors in gastrointestinal stromal tumors with PDGFRA D842V mutation: a retrospective analysis of clinical trial and real-world data. BMC Cancer. 2021 Mar 19;21(1):291. doi: 10.1186/s12885-021-08013-1.

ReferenceCitation: Jones RL, Serrano C, von Mehren M, George S, Heinrich MC, Kang YK, Schöffski P, Cassier PA, Mir O, Chawla SP, Eskens FALM, Rutkowski P, Tap WD, Zhou T, Roche M, Bauer S. Avapritinib in unresectable or metastatic PDGFRA D842V-mutant gastrointestinal stromal tumours: Long-term efficacy and safety data from the NAVIGATOR phase I trial. Eur J Cancer. 2021 Mar;145:132-142. doi: 10.1016/j.ejca.2020.12.008. Epub 2021 Jan 16.

ReferenceCitation: Joseph CP, Abaricia SN, Angelis MA, Polson K, Jones RL, Kang YK, Riedel RF, Schöffski P, Serrano C, Trent J, Tetzlaff ED, Si TD, Zhou T, Doyle A, Bauer S, Roche M, Havnaer T. Optimal Avapritinib Treatment Strategies for Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumors. Oncologist. 2021 Apr;26(4):e622-e631. doi: 10.1002/onco.13632. Epub 2021 Jan 5.

name: The University of Texas MD Anderson Cancer Center  Houston Texas USA

name: Washington University School of Medicine  St. Louis Missouri USA

name: James Cancer Hospital and Solove Research Institute and The Ohio State University Wexner Medical Center  Columbus Ohio USA

name: Dana‐Farber Cancer Institute  Boston Massachusetts USA

name: Royal Marsden Hospital and Institute of Cancer Research  London England

name: Asan Medical Center, University of Ulsan  Seoul South Korea

name: Duke Cancer Institute, Duke University Medical Center  Durham North Carolina USA

name: University Hospitals Leuven, Leuven Cancer Institute  Leuven Belgium

name: Vall d'Hebron Institute of Oncology  Barcelona Spain

name: Sylvester Comprehensive Cancer Center, University of Miami  Miami Florida USA

name: Fox Chase Cancer Center  Philadelphia Pennsylvania USA

name: Blueprint Medicines Corporation  Cambridge Massachusetts USA

name: University of Duisburg‐Essen  Essen Germany

name: Oregon Health & Science University  Portland, Oregon USA

ReferenceCitation: Heinrich MC, Jones RL, von Mehren M, Schöffski P, Serrano C, Kang YK, Cassier PA, Mir O, Eskens F, Tap WD, Rutkowski P, Chawla SP, Trent J, Tugnait M, Evans EK, Lauz T, Zhou T, Roche M, Wolf BB, Bauer S, George S. Avapritinib in advanced PDGFRA D842V-mutant gastrointestinal stromal tumour (NAVIGATOR): a multicentre, open-label, phase 1 trial. Lancet Oncol. 2020 Jul;21(7):935-946. doi: 10.1016/S1470-2045(20)30269-2. Erratum in: Lancet Oncol. 2020 Sep;21(9):e418.

ReferenceCitation: Gebreyohannes YK, Wozniak A, Zhai ME, Wellens J, Cornillie J, Vanleeuw U, Evans E, Gardino AK, Lengauer C, Debiec-Rychter M, Sciot R, Schöffski P. Robust Activity of Avapritinib, Potent and Highly Selective Inhibitor of Mutated KIT, in Patient-derived Xenograft Models of Gastrointestinal Stromal Tumors. Clin Cancer Res. 2019 Jan 15;25(2):609-618. doi: 10.1158/1078-0432.CCR-18-1858. Epub 2018 Oct 1.

publisher_dissemination: American Association for Cancer Research

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

location_facility: Fondazione IRCCS - Istituto Nazinale dei Tumori

location_facility: Leuven Cancer Institute University Hospitals Leuven

location_facility: Scottsdale Healthcare Hospitals DBA HonorHealth

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie w Warszawie

location_facility: Vall d' Hebron Institute of Oncology (VHIO)


lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
Switzerland
France
Israel
Australia
United States

acronym: Ph 1/2 Substudy of Oncological Treatment(s) in PD-1 naïve or PD-1 exposed participants with MBM

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 4602)

location_facility: Centre Hospitalier Lyon Sud ( Site 4102)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 4012)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 4377)

location_facility: Hadassah Ein Karem Jerusalem ( Site 4702)

location_facility: Inova Schar Cancer Institute ( Site 4011)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4399)

location_facility: Providence Saint John's Health Center ( Site 4010)

location_facility: Melanoma Institute Australia ( Site 4402)

location_facility: Istituto Europeo di Oncologia ( Site 4301)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 4355)

location_facility: Rambam Health Care Campus-Oncology ( Site 4704)

location_facility: The Angeles Clinic and Research Institute ( Site 4009)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 4022)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 4302)

location_facility: Universitaetsspital Zuerich ( Site 4601)

title: A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02D

summary:
Substudy 02D is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02D is to evaluate the safety and efficacy of investigational treatment arms in programmed cell-death 1 (PD-1) naïve or PD-1 exposed participants with melanoma brain metastasis (MBM) and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

acronym: InMIND

summary: This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Austria
United States
France
Czechia
Greece
Israel
Australia
Belgium
Spain
Canada
Korea, Republic of

location_facility: Hospital General Universitario de Alicante- ISABIAL

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Charleston Hematology Oncology Associates

location_facility: University Hospital and Faculty of Medicine, 4th Department of Internal Medicine - Haematology

location_facility: Severance Hospital Yonsei University Health System

location_facility: Des Moines Oncology Research Association

location_facility: Hospital Saint-Louis Service Oncologie Medicale

location_facility: "Laiko" General Hospital of Athens, Hematology of the First Propaedeutic Internal Medicine Clinic

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: The Center For Cancer and Blood Disorders

location_facility: Universitair Ziekenhuis Antwerpen, Dienst Hematologie

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Texas Oncology-Baylor Charles A. Sammons

location_facility: Wollongong Hospital - Illawarra Regional Hospital

location_facility: Chu Ucl Namur University Hospital Mont-Godinne

location_facility: University of Maryland - Greenebaum Cancer Center

location_facility: Hospital Universitario Virgen del Rocio Sevilla