type: Registry Identifier

title: A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)

acronym: QuANTUM-First

summary:
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.

Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML).

Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

ReferenceCitation: Cortes J, Perl AE, Döhner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Krämer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
Israel
Singapore
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Korea, Republic of
France

location_facility: Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona

location_facility: Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: The University of Chicago Medical Center

location_facility: National Hospital Organization Kagoshima Medical Center

location_facility: University Hospitals Seidman Cancer Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

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

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Franciscan St. Francis Health Indianapolis

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Centro Hospitalar de São João, EPE - Hospital de São João

location_facility: Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School

location_facility: Kobe City Medical Center General Hospital

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca

location_facility: Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Russian Research Institute of Hematology and Blood Transfusion

location_facility: Hospital of the University of Pennsylvania

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot

location_facility: Hospital Regional Universitario de Málaga - Hospital General

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos

location_facility: Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette

location_facility: Saratov State Medical University named after V.I. Razumovsky

location_facility: Azienda Ospedaliera Nazionale SS.Antonio e Biagio e Cesare Arrigo

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

location_facility: Fujian Medical University Union Hospital

location_facility: Complejo Hospitalario Universitario Granada

location_facility: Kameda Medical Center - Kameda General Hospital

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr. 1 we Wrocławiu

location_facility: Complejo Hospitalario Universitario de Albacete - Hospital General Universitario

location_facility: Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara

location_facility: Almazov Federal North-West Medical Research Centre

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

location_facility: Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4005)

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

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

location_facility: Hospital General Universitario de Alicante

location_facility: Chang Gung Medical Foundation - Linkou Branch

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Instituto do Cancer do Estado de São Paulo

location_facility: Daegu Catholic University Medical Center

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António

location_facility: National University Hospital (S) Pte Ltd

location_facility: Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: West Virginia University Hospitals, Inc.

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario

location_facility: University of Kentucky Chandler Medical Center

location_facility: The General Hospital of People's Liberation Army (301 Hospital)

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Vseobecna Fakultni Nemocnice, Ustav hematologie a krevni transfuze (UHKT)

location_facility: NY Medical College - Hudson Valley Hematology Oncology Associates

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno

location_facility: Hospital Universitari Joan XXIII de Tarragona

location_facility: Azienda Ospedaliero - Universitaria Consorziale Policlinico di Bari

location_facility: Tang Du Hospital, Fourth Military Medical University

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga

location_facility: Seoul National University Bundang Hospital

location_facility: Instituto Português Oncologia do Porto Francisco Gentil, EPE

location_facility: Hospital Clínico Universitario "Lozano Blesa"

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Nizhny Novgorod Regional Clinical Hospital

location_facility: University of Florida (UF) Health Shands Hospital

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

location_facility: ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi Varese

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

location_facility: Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4008)

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra

location_facility: Chang Gung Medical Foundation - Kaohsiung Branch

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: University Multiprofile Hospital for Active Treatment "Dr. G. Stranski" EAD

location_facility: Complexo Hospitalario Universitario A Coruña


type: Other Identifier

title: Assessment of STELARA® (Ustekinumab) and Tumor Necrosis Factor Alpha Inhibitor Therapies in Patients With Psoriatic Arthritis in Standard Health-Care Practice; A Prospective, Observational Cohort

acronym: PsaBio

summary: The purpose of this study is to evaluate treatment retention in psoriatic arthritis participants with STELARA or tumor necrosis factor alpha inhibitor (TNFi) therapies in relation to effectiveness, safety, benefit/risk and to examine clinical response.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gossec L, Siebert S, Bergmans P, de Vlam K, Gremese E, Joven-Ibáñez B, Korotaeva TV, Lavie F, Noël W, Nurmohamed MT, Sfikakis PP, Theander E, Smolen JS. Persistence and effectiveness of the IL-12/23 pathway inhibitor ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: 1-year results from the real-world PsABio Study. Ann Rheum Dis. 2022 Jun;81(6):823-830. doi: 10.1136/annrheumdis-2021-221640. Epub 2022 Feb 24.

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Spain
Greece
Russian Federation
United Kingdom
France
Belgium
Netherlands

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


primary_purpose: Treatment

acronym:
Nintedanib in SSc-ILD

 Nindedanib dans la SSc-ILD

title: A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

lead_sponsor: Boehringer Ingelheim

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_type: Interventional

ReferenceCitation: Denton CP, Goh NS, Humphries SM, Maher TM, Spiera R, Devaraj A, Ho L, Stock C, Erhardt E, Alves M, Wells AU; SENSCIS trial investigators. Extent of fibrosis and lung function decline in patients with systemic sclerosis and interstitial lung disease: data from the SENSCIS trial. Rheumatology (Oxford). 2022 Sep 16. pii: keac535. doi: 10.1093/rheumatology/keac535. [Epub ahead of print]

ReferenceCitation: Maher TM, Bourdin A, Volkmann ER, Vettori S, Distler JHW, Alves M, Stock C, Distler O. Decline in forced vital capacity in subjects with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial compared with healthy reference subjects. Respir Res. 2022 Jul 5;23(1):178. doi: 10.1186/s12931-022-02095-6.

ReferenceCitation: Kreuter M, Hoffmann-Vold AM, Matucci-Cerinic M, Saketkoo LA, Highland KB, Wilson H, Alves M, Erhardt E, Schoof N, Maher TM. Impact of lung function and baseline clinical characteristics on patient-reported outcome measures in systemic sclerosis-associated interstitial lung disease. Rheumatology (Oxford). 2022 May 31:keac325. doi: 10.1093/rheumatology/keac325. Online ahead of print.

ReferenceCitation: Volkmann ER, Kreuter M, Hoffmann-Vold AM, Wijsenbeek M, Smith V, Khanna D, Denton CP, Wuyts WA, Miede C, Alves M, Sambevski S, Allanore Y. Dyspnoea and cough in patients with systemic sclerosis-associated interstitial lung disease in the SENSCIS trial. Rheumatology (Oxford). 2022 Nov 2;61(11):4397-4408. doi: 10.1093/rheumatology/keac091.

ReferenceCitation: Kreuter M, Del Galdo F, Miede C, Khanna D, Wuyts WA, Hummers LK, Alves M, Schoof N, Stock C, Allanore Y. Impact of lung function decline on time to hospitalisation events in systemic sclerosis-associated interstitial lung disease (SSc-ILD): a joint model analysis. Arthritis Res Ther. 2022 Jan 10;24(1):19. doi: 10.1186/s13075-021-02710-9.

ReferenceCitation: Highland KB, Distler O, Kuwana M, Allanore Y, Assassi S, Azuma A, Bourdin A, Denton CP, Distler JHW, Hoffmann-Vold AM, Khanna D, Mayes MD, Raghu G, Vonk MC, Gahlemann M, Clerisme-Beaty E, Girard M, Stowasser S, Zoz D, Maher TM; SENSCIS trial investigators. Efficacy and safety of nintedanib in patients with systemic sclerosis-associated interstitial lung disease treated with mycophenolate: a subgroup analysis of the SENSCIS trial. Lancet Respir Med. 2021 Jan;9(1):96-106. doi: 10.1016/S2213-2600(20)30330-1.

ReferenceCitation: Roennow A, Sauvé M, Welling J, Riggs RJ, Kennedy AT, Galetti I, Brown E, Leite C, Gonzalez A, Portales Guiraud AP, Houÿez F, Camp R, Gilbert A, Gahlemann M, Moros L, Luna Flores JL, Schmidt F, Sauter W, Finnern H. Collaboration between patient organisations and a clinical research sponsor in a rare disease condition: learnings from a community advisory board and best practice for future collaborations. BMJ Open. 2020 Dec 16;10(12):e039473. doi: 10.1136/bmjopen-2020-039473.

ReferenceCitation: Azuma A, Chung L, Behera D, Chung M, Kondoh Y, Ogura T, Okamoto M, Swarnakar R, Zeng X, Zou H, Meng X, Gahlemann M, Alves M, Kuwana M; SENSCIS trial investigators. Efficacy and safety of nintedanib in Asian patients with systemic sclerosis-associated interstitial lung disease: Subgroup analysis of the SENSCIS trial. Respir Investig. 2021 Mar;59(2):252-259. doi: 10.1016/j.resinv.2020.10.005. Epub 2020 Nov 19.

ReferenceCitation: Maher TM, Mayes MD, Kreuter M, Volkmann ER, Aringer M, Castellvi I, Cutolo M, Stock C, Schoof N, Alves M, Raghu G; SENSCIS Trial Investigators. Effect of Nintedanib on Lung Function in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease: Further Analyses of a Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Apr;73(4):671-676. doi: 10.1002/art.41576. Epub 2021 Mar 8.

ReferenceCitation: Kuwana M, Ogura T, Makino S, Homma S, Kondoh Y, Saito A, Ugai H, Gahlemann M, Takehara K, Azuma A. Nintedanib in patients with systemic sclerosis-associated interstitial lung disease: A Japanese population analysis of the SENSCIS trial. Mod Rheumatol. 2021 Jan;31(1):141-150. doi: 10.1080/14397595.2020.1751402. Epub 2020 Apr 23.

ReferenceCitation: Distler O, Highland KB, Gahlemann M, Azuma A, Fischer A, Mayes MD, Raghu G, Sauter W, Girard M, Alves M, Clerisme-Beaty E, Stowasser S, Tetzlaff K, Kuwana M, Maher TM; SENSCIS Trial Investigators. Nintedanib for Systemic Sclerosis-Associated Interstitial Lung Disease. N Engl J Med. 2019 Jun 27;380(26):2518-2528. doi: 10.1056/NEJMoa1903076. Epub 2019 May 20.

ReferenceCitation: Distler O, Brown KK, Distler JHW, Assassi S, Maher TM, Cottin V, Varga J, Coeck C, Gahlemann M, Sauter W, Schmidt H, Highland KB; SENSCIS™ trial investigators. Design of a randomised, placebo-controlled clinical trial of nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SENSCIS™). Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 106(4):75-81. Epub 2017 Jun 29.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Portugal
Austria
Australia
Argentina
India
Israel
Mexico
Norway
Malaysia
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Greece
Ireland
Finland
Thailand
France
Chile
Netherlands

location_facility: Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

location_facility: Washington University School of Medicine

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: CEMER-Centro Medico De Enfermedades Respiratorias

location_facility: The First Hospital of Chinese Medical University

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: National Hospital Organization Himeji Medical Center

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Clinical Rheumatology Research Center Sahlgrenska

location_facility: Kantonspital St. Gallen, Rheumatologie Department

location_facility: Postgraduate Institute of Medical Education And Research

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Jehangir Clinical Development Centre Pvt. Ltd.

location_facility: Semmelweis University, Dept. Pulmonology

location_facility: B.J. Medical College and Sasoon General Hospital

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: ULSAM, EPE - Hospital Conde de Bertiandos

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

location_facility: University of Florida College of Medicine

location_facility: University of Minnesota Masonic Cancer Center

location_facility: University of Utah Health Sciences Center

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Institute of Rheumatology Tokyo Women's Medical University

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: EMED, Center of Medical Services,Private Prac,Rzeszow

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Azienda Universitaria-Universita' La Sapienza

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: University of Texas Southwestern Medical Center

summary: Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.


ipd_sharing: No

status: Recruiting

acronym: NAVIGATE

title: A Phase 2 Basket Study of the Oral TRK Inhibitor Larotrectinib in Subjects With NTRK Fusion-positive Tumors

study_completion_date_type: Anticipated

lead_sponsor: Bayer

design_allocation: Non-Randomized

ReferenceCitation: Le X, Baik C, Bauman J, Gilbert J, Brose MS, Grilley-Olson JE, Patil T, McDermott R, Raez LE, Johnson JM, Shen L, Tahara M, Ho AL, Norenberg R, Dima L, Brega N, Drilon A, Hong DS. Larotrectinib Treatment for Patients With TRK Fusion-Positive Salivary Gland Cancers. Oncologist. 2022 May 10. pii: oyac080. doi: 10.1093/oncolo/oyac080. [Epub ahead of print]

ReferenceCitation: Drilon A, Tan DSW, Lassen UN, Leyvraz S, Liu Y, Patel JD, Rosen L, Solomon B, Norenberg R, Dima L, Brega N, Shen L, Moreno V, Kummar S, Lin JJ. Efficacy and Safety of Larotrectinib in Patients With Tropomyosin Receptor Kinase Fusion-Positive Lung Cancers. JCO Precis Oncol. 2022 Jan;6:e2100418. doi: 10.1200/PO.21.00418.

ReferenceCitation: Doz F, van Tilburg CM, Geoerger B, Højgaard M, Øra I, Boni V, Capra M, Chisholm J, Chung HC, DuBois SG, Gallego-Melcon S, Gerber NU, Goto H, Grilley-Olson JE, Hansford JR, Hong DS, Italiano A, Kang HJ, Nysom K, Thorwarth A, Stefanowicz J, Tahara M, Ziegler DS, Gavrilovic IT, Norenberg R, Dima L, De La Cuesta E, Laetsch TW, Drilon A, Perreault S. Efficacy and safety of larotrectinib in TRK fusion-positive primary central nervous system tumors. Neuro Oncol. 2022 Jun 1;24(6):997-1007. doi: 10.1093/neuonc/noab274.

ReferenceCitation: Lee YA, Lee H, Im SW, Song YS, Oh DY, Kang HJ, Won JK, Jung KC, Kwon D, Chung EJ, Hah JH, Paeng JC, Kim JH, Choi J, Kim OH, Oh JM, Ahn BC, Wirth LJ, Shin CH, Kim JI, Park YJ. NTRK and RET fusion-directed therapy in pediatric thyroid cancer yields a tumor response and radioiodine uptake. J Clin Invest. 2021 Sep 15;131(18). pii: 144847. doi: 10.1172/JCI144847.

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.

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.

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: O'Reilly EM, Hechtman JF. Tumour response to TRK inhibition in a patient with pancreatic adenocarcinoma harbouring an NTRK gene fusion. Ann Oncol. 2019 Nov 1;30(Suppl_8):viii36-viii40. doi: 10.1093/annonc/mdz385. Epub 2019 Dec 24.

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.

ReferenceCitation: Shi E, Chmielecki J, Tang CM, Wang K, Heinrich MC, Kang G, Corless CL, Hong D, Fero KE, Murphy JD, Fanta PT, Ali SM, De Siena M, Burgoyne AM, Movva S, Madlensky L, Heestand GM, Trent JC, Kurzrock R, Morosini D, Ross JS, Harismendy O, Sicklick JK. FGFR1 and NTRK3 actionable alterations in "Wild-Type" gastrointestinal stromal tumors. J Transl Med. 2016 Dec 14;14(1):339.

ipd_sharing_description:
Availability of this study's data will later 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.vivli.org 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 member section of the portal.

enrollment_type: Anticipated

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
India
Turkey
Norway
Singapore
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Greece
Ireland
Korea, Republic of
France
Colombia

location_facility: Kokilaben Dhirubhai Ambani Hospital & Medical Research Insti

location_facility: IRCCS Istituti Fisioterapici Ospitalieri - IFO

location_facility: St. Petersburg Clinical Onc. Cent. of Spec. Types of Care

location_facility: ICANS - Institut de Cancérologie de Strasbourg Europe

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Hospital Clínico Universitario de Valencia

location_facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi

location_facility: Institute Of Cancer-Barts and The London School of Medicine

location_facility: 1st Moscow State Medical University n.a. I.M.Sechenov

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Hospital General Universitario de Valencia

location_facility: TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

location_facility: Centro Estudios Médicos e Invest. Clínicas "Dr. N. Quirno"

location_facility: Fundación Cenit para la Investigación en Neurociencias

location_facility: Cenantron Centro Avançado de Tratamento Oncológico, Ltda.

location_facility: Instituto Nacional do Câncer - INCA - HC II

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer

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

location_facility: Onkologicky Ustav Svatej Alzbety, s.r.o.

location_facility: Instituto Nacional de Cancerología INC Colombia

location_facility: Hospital Universitario "Marqués de Valdecilla"

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Republican Clinical Oncology Dispensary Kazan

location_facility: Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

location_facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

location_facility: Jawaharlal Institute Of Postgraduate Medical Education and R

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma

location_facility: Arkhangelsk Clinical Oncology Dispensary

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Fundación Oftalmológica de Santander Carlos Ardila Lule

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Moscow Clinical Scientific Centre n.a.Loginov

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Charité Comprehensive Cancer Center (CCCC)

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: Clín. de Pesq. e Centro de Estudos em Onco Gineco Mamária

location_facility: Hospital General Universitario Gregorio Marañón | Oncología

location_facility: Hôpital Guillaume et René Laennec - Nantes

location_facility: Instituto do Câncer do Estado de São Paulo

location_facility: Karolinska Universitetssjukhuset i Solna

location_facility: Hospital de Base da Fundação F M S J Rio Preto

location_facility: Institut Jules Bordet/Jules Bordet Instituut

location_facility: AGIOS SAVVAS Anticancer Hospital of Athens

location_facility: Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

location_facility: A.S.U. Friuli Centrale - A. Regionale Coordinamento Salute

location_facility: Juravinski Cancer Centre-McMaster Medical Unit

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Hosp. Araujo Jorge da Associação de Combate ao Câncer

location_facility: General Oncology Hospital of Kifissia AGIOI ANARGYROI

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: London Regional Cancer Program, London Health Sciences Ctr

summary: This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is a drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

status_simplified: Ongoing


acronym: PHOCUS

intervention_type: Biological

title: A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

lead_sponsor: SillaJen, Inc.

location_country:
Taiwan
Hong Kong
Portugal
United Kingdom
Italy
Australia
New Zealand
Canada
Thailand
Korea, Republic of
United States
France
China
Israel
Singapore
Germany

location_facility: Washington University School of Medicine

location_facility: Benaroya Research Institute at Virginia Mason Hospital

location_facility: Hospital of The University of Pennsylvania

location_facility: Tulane University Health Sciences Center

location_facility: University of Texas Southwestern Medical Center

summary: This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.


ipd_sharing: Yes

title: Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome.

lead_sponsor: Novo Nordisk A/S

ReferenceType: result

ReferenceCitation: Diene G, Angulo M, Hale PM, Jepsen CH, Hofman PL, Hokken-Koelega A, Ramesh C, Turan S, Tauber M. Liraglutide for Weight Management in Children and Adolescents with Prader-Willi Syndrome and Obesity. J Clin Endocrinol Metab. 2022 Oct 1. pii: dgac549. doi: 10.1210/clinem/dgac549. [Epub ahead of print]

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

location_country:
Italy
Australia
New Zealand
Canada
United States
France
Turkey
Netherlands

summary: This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.


title: ARMOR3-SV: A Phase 3, Randomized, Open Label, Multi-Center, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC)

summary: The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).

status: Terminated

ReferenceCitation: Aragon-Ching JB. The promising role of poly(ADP-ribose) polymerase inhibitors in prostate cancer. Asian J Androl. 2016 Jul-Aug;18(4):592-3. doi: 10.4103/1008-682X.172821.

lead_sponsor: Novus Therapeutics, Inc

location_country:
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Belgium

location_facility: Texas Oncology/Baylor University Medical Center

location_facility: Walter Reed National Military Medical Center

location_facility: Centro Oncologico c/o Presidio Ospedaliero San Donato - Arezzo

location_facility: Unità Operativa di Oncologia Ospedale Civile degli Infe

location_facility: Ashford Cancer Centre/Adelaide Cancer Centre Research

location_facility: University of Maryland Greenenbaum Cancer Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Centre Hospitalier De I'Universite de Montreal

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

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Jules Bordet Institute Clinique d'Oncologie Medicale

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: University of North Carolina Lineberger Cancer Center

location_facility: University of Surrey Post Graduate Medical Hospital

location_facility: Hospital Clinico Universitario de Navarra

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Instituto Catalan de Oncologia (Hospital Durans i Reynals)

location_facility: Urology Cancer Center and GU Research Network

location_facility: Unidad Cnio Ibima de Investigacion en Prostata

location_facility: Premier Medical Group of the Hudson Valley

location_facility: Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica

location_facility: University of Florida Health Cancer Center

location_facility: Hospital Clínic i Provincial de Barcelona-Oncology

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Clinique Victor Hugo Centre Jean Bernard

location_facility: Service de Médecine Interne Onco-Hématologie

location_facility: University of Colorado Cancer Center Anschultz Cancer Pavilion

location_facility: St. George Private Hospital, Oncology Day Care Centre

location_facility: The University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

status_simplified: Unknown


title: A PHASE 2 RANDOMIZED, DOUBLE-BLIND TRIAL OF MHAA4549A, A MONOCLONAL ANTIBODY IN COMBINATION WITH OSELTAMIVIR VERSUS OSELTAMIVIR FOR TREATMENT OF SEVERE INFLUENZA A INFECTION

lead_sponsor: Genentech, Inc.

ReferenceCitation: Lim JJ, Nilsson AC, Silverman M, Assy N, Kulkarni P, McBride JM, Deng R, Li C, Yang X, Nguyen A, Horn P, Maia M, Castro A, Peck MC, Galanter J, Chu T, Newton EM, Tavel JA. A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, plus Oseltamivir in Patients Hospitalized with Severe Influenza A Virus Infection. Antimicrob Agents Chemother. 2020 Jun 23;64(7). pii: e00352-20. doi: 10.1128/AAC.00352-20. Print 2020 Jun 23.

location_country:
Spain
Italy
United Kingdom
Ukraine
Peru
Belgium
South Africa
Czechia
Poland
Hong Kong
Russian Federation
Israel
Mexico
Sweden
Brazil
Canada
Hungary
Germany
Bulgaria
Taiwan
New Zealand
Korea, Republic of
France
Chile
Netherlands

location_facility: Taunton and Somerset NHS Foundation Trust Musgrove Park Hospital

location_facility: Leeds General Infirmary, Anaesthetic Department, D Floor

location_facility: Royal Jubilee Hospital Victoria general Hospital

location_facility: Centro de Especialidades Medicas Del Estado de Veracruz Dr Rafael Lucio

location_facility: Centre Hospitalier de la Universite Laval

location_facility: MHAT Lyulin EAD, Department of internal diseases

location_facility: National Institute for Infectious Diseases "L. Spallanzani"

location_facility: Centre de santé et de services sociaux de Trois-Rivières

location_facility: Service de réanimation médicale, Hôpital Bretonneau

location_facility: Clinica Divino Nino Jesus; Orden de Malta

location_facility: Hospital Civil de Guadalajara Dr Juan I Menchaca

location_facility: Poltava Regional Clinical Infectious Hospital

location_facility: Hospital Univ. de Getafe.Servicio de Neurologia

location_facility: Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almen

location_facility: Service de Réanimation médicale - Bocage Central

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Hallym university Kangnam Sacred Heart Hospital; Infectious devision

location_facility: University Hospital Modena, Intensive Care Unit

location_facility: King College Hospital NHS Foundation Trust

location_facility: LHSC - University Hospital; Research Pharmacy

location_facility: Yonsei University Health System/Severance Hospital

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Municipal Healthcare Institution "City Hospital №2"

location_facility: Oddział Anestezjologii i Intensywnej Terapii;Wojewódzki Szpital Zespolony im. L. Rydygiera

location_facility: Multiprofile Hospital for Active Treatment AKTA-MEDIKA EOOD

location_facility: Southampton University Hospitals NHS Trust

location_facility: Oddział Anestezjologii i Intensywnej Terapii Wojewódzki Specjalistyczny Szpital im dr Wł Biegańsk

location_facility: Uppsala University Hospital, Department of Infectious Diseases

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD

location_facility: SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: St. Paul's Hospital, Providence Health Care

location_facility: Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador Zubiran

location_facility: Hospital de la Amistad Peru Corea II-2 Santa Rosa

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD

location_facility: University Division of Infective and Tropical Diseases, University of Brescia, Italy

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: University Multiprofile Hospital for Active Treatment "St. George"

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: 5th Multifunctional Hospital for Active treatment

location_facility: Gelre Ziekenhuizen Apeldoorn; Hospitals Pharmacy

location_facility: University hospital Ostrava, Clinic of infectious medicine

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: Municipal Institution Central City Hospital #1 City of Zhytomyr

location_facility: Fakultni nemocnice Kralovske Vinohrady, Klinika anesteziologie a resuscitace

location_facility: Municipal Institution City Clinical Infectious Diseases Hospital

location_facility: Erasmus Medical Centre; Department of Virology L-359

location_facility: Servicio de Medicina Intensiva Hospital Universitario la Fe

location_facility: A.O.U. S. Giovanni di Dio e Ruggi d'Aragona

location_facility: Anesthesia and Intensive Care Dept., Regional Hospital Liberec

location_facility: MHAT TOKUDA SOFIA/ICU-Intensive Care Unit

location_facility: Kaohsiung Medical University Hospital, Cancer Center

location_facility: Hadasit Medical Research Services and Development Ltd

location_facility: University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

location_facility: Universitätsklinikum Frankfurt Goethe Universität

summary: This is a randomized, double-blind, placebo-controlled study that will investigate the safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm of placebo with oseltamivir.


primary_purpose: Other

acronym: BORA

title: A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)

lead_sponsor: AstraZeneca

ReferenceCitation: Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Brooks L, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Benralizumab for adolescent patients with severe, eosinophilic asthma: Safety and efficacy after 3 years of treatment. J Allergy Clin Immunol. 2021 Jul;148(1):266-271.e2. doi: 10.1016/j.jaci.2021.02.009. Epub 2021 Feb 17.

ReferenceCitation: Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Sproule S, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019 Jan;7(1):46-59. doi: 10.1016/S2213-2600(18)30406-5. Epub 2018 Nov 8. Erratum in: Lancet Respir Med. 2019 Jan;7(1):e1.

location_country:
Spain
United Kingdom
Ukraine
United States
Peru
Romania
Philippines
Japan
South Africa
Czechia
Poland
Russian Federation
Australia
Argentina
Turkey
Sweden
Brazil
Canada
Germany
Bulgaria
Vietnam
Korea, Republic of
France
Chile

summary: The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.


title: Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)

summary: This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).

primary_purpose: Prevention

ReferenceCitation: Del Brutto VJ, Diener HC, Easton JD, Granger CB, Cronin L, Kleine E, Grauer C, Brueckmann M, Toyoda K, Schellinger PD, Lyrer P, Molina CA, Chutinet A, Bladin CF, Estol CJ, Sacco RL. Predictors of Recurrent Stroke After Embolic Stroke of Undetermined Source in the RE-SPECT ESUS Trial. J Am Heart Assoc. 2022 Jun 7;11(11):e023545. doi: 10.1161/JAHA.121.023545. Epub 2022 Jun 3.

ReferenceCitation: Diener HC, Easton JD, Hart RG, Kasner S, Kamel H, Ntaios G. Review and update of the concept of embolic stroke of undetermined source. Nat Rev Neurol. 2022 Aug;18(8):455-465. doi: 10.1038/s41582-022-00663-4. Epub 2022 May 10. Review.

ReferenceCitation: Bahit MC, Sacco RL, Easton JD, Meyerhoff J, Cronin L, Kleine E, Grauer C, Brueckmann M, Diener HC, Lopes RD, Brainin M, Lyrer P, Wachter R, Segura T, Granger CB; RE-SPECT ESUS Steering Committee and Investigators. Predictors of Atrial Fibrillation Development in Patients With Embolic Stroke of Undetermined Source: An Analysis of the RE-SPECT ESUS Trial. Circulation. 2021 Nov 30;144(22):1738-1746. doi: 10.1161/CIRCULATIONAHA.121.055176. Epub 2021 Oct 15.

ReferenceCitation: Uchiyama S, Toyoda K, Lee BC, Liou CW, Wong LKS, Grauer C, Brueckmann M, Taniguchi A, Urano Y, Easton JD; RE-SPECT ESUS Investigators. Dabigatran or Aspirin in East Asian Patients With Embolic Stroke of Undetermined Source: RE-SPECT ESUS Subgroup Analysis. Stroke. 2021 Mar;52(3):1069-1073. doi: 10.1161/STROKEAHA.120.031891. Epub 2021 Feb 16.

ReferenceCitation: Diener HC, Chutinet A, Easton JD, Granger CB, Kleine E, Marquardt L, Meyerhoff J, Zini A, Sacco RL. Dabigatran or Aspirin After Embolic Stroke of Undetermined Source in Patients With Patent Foramen Ovale: Results From RE-SPECT ESUS. Stroke. 2021 Mar;52(3):1065-1068. doi: 10.1161/STROKEAHA.120.031237. Epub 2021 Jan 28.

ReferenceCitation: Diener HC, Sacco RL, Easton JD, Granger CB, Bar M, Bernstein RA, Brainin M, Brueckmann M, Cronin L, Donnan G, Gdovinová Z, Grauer C, Kleine E, Kleinig TJ, Lyrer P, Martins S, Meyerhoff J, Milling T, Pfeilschifter W, Poli S, Reif M, Rose DZ, Šaňák D, Schäbitz WR. Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups. Stroke. 2020 Jun;51(6):1758-1765. doi: 10.1161/STROKEAHA.119.028643. Epub 2020 May 14.

ReferenceCitation: Diener HC, Sacco RL, Easton JD, Granger CB, Bernstein RA, Uchiyama S, Kreuzer J, Cronin L, Cotton D, Grauer C, Brueckmann M, Chernyatina M, Donnan G, Ferro JM, Grond M, Kallmünzer B, Krupinski J, Lee BC, Lemmens R, Masjuan J, Odinak M, Saver JL, Schellinger PD, Toni D, Toyoda K; RE-SPECT ESUS Steering Committee and Investigators. Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med. 2019 May 16;380(20):1906-1917. doi: 10.1056/NEJMoa1813959.

location_country:
Croatia
Serbia
Spain
Italy
Ukraine
United States
Peru
Belgium
Japan
South Africa
Czechia
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Taiwan
Greece
Estonia
New Zealand
Thailand
Korea, Republic of
France
Chile
Colombia

location_facility: First Affiliated Hospital of Xiamen University

location_facility: Centennial Heart Cardiovascular Consultants, LLC

location_facility: Regional Hospital Lugano,Neurocenter of Southern Switzerland

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Research Inst. of Emerg. Med., Vascul. Center,St. Petersburg

location_facility: Southern Illinois University School of Medicine

location_facility: Università degli Studi Campus Bio-Medico

location_facility: Abbott Northwestern Hospital, Radiology Department

location_facility: Military Medical Academy n.a. C. M. Kirov, St. Petersburg

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Reg.State Instit.of Healthc.Smolensk Reg.Clin.Hosp,Neurology

location_facility: General Hospital of Shenyang Military Region

location_facility: Bruce W. Carter, Miami VA Healthcare System

location_facility: Azienda Ospedaliero Universitaria di Ferrara

location_facility: UHS Wilson Medical Center,Office of Clin Trials

location_facility: H.C.da Fac. de Medicina de Ribeirao Preto

location_facility: Ruan Neurology Clinic and Research Center

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Noroloji A.B.D.

location_facility: Hosp.Hietzing with Neuro.Centr Rosenhuegel,II Neuro.dep,Wien

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Vero Beach Neurology and Research Institute

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Saitama Medical University International Medical Center

location_facility: Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Hacettepe Universitesi Tip Fakultesi Noroloji A.B.D.

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Osp. Guglielmo da Saliceto AUSL di Piacenza

location_facility: Seoul National University Bundang Hospital

location_facility: The Chaim Sheba Medical Center Tel Hashomer

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

location_facility: Mangala Hospital and Mangala Kidney Foundation

location_facility: Reg.Clin.Hosp#1 na S.V.Ochapovskiy,Neurology#1 Dep,Krasnodar

location_facility: Spec.Hosp.of Dr. Wladyslaw Bieganski in Grudziadz

location_facility: Research&Clini Cent Neuropsychiatry Dep. Healthcare,Moscow

location_facility: Quincy Physicians and Surgeons Clinic, S.C.

location_facility: National Hospital Organization Kagoshima Medical Center

location_facility: Ospedale Molinette, AO Città della Salute e della

location_facility: Japan Community Health Care Organization Kyushu Hospital

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Clin.Hosp.Centre Zagreb,Cerebrovascul.disease w/ intens.care

location_facility: Post Graduate Institute of Medical Education and Research

location_facility: Kobe City Medical Center General Hospital

location_facility: Kortrijk - HOSP AZ Groeninge Kennedylaan

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Sacred Heart Medical Center at RiverBend

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: University of Alberta Hospital (University of Alberta)

location_facility: 2nd Affiliated Hosp Zhejiang University College of Medical

location_facility: City Clin.Hosp#1na N.I.Pirogov,Dept of Healthcare of Moscow

location_facility: Eskisehir Osmangazi Universitesi Tip Fakultesi

location_facility: CHUV - Centre hospitalier universitaire vaudois

location_facility: Sociedad de Cirugia de Bogota Hospital de San José

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona

location_facility: Cerebrovascular site, private prac., Brno

location_facility: Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: The Ohio State University Wexner Medical Center

location_facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Noroloji A.B.D.

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Saratov State Med.Univ na V.I.Razumovsky,FacultyTherapy Clin

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO

location_facility: The First Affiliated Hospital of Jinan University

location_facility: Universitätsklinikum Tulln, Abteilung für Neurologie

location_facility: Specialist Holy Spirit Hospital, Neurology Dept,Sandomierz

location_facility: Gesundheit Nord gGmbH | Klinikverbund Bremen

location_facility: National Instit.of Neurosciences,Neurology Dept,Budapest

location_facility: Instituto Nacional de Ciencias Neurológicas

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Cardial d.o.o., Specialist out-patient unit, Ljubljana

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: St. Josef- und St. Elisabeth-Hospital gGmbH

location_facility: The affiliated hospital of medicalcollege qingdao university

location_facility: West Tallinn Central Hospital, Neurology Dept.

location_facility: Clin.Research Center,Leszek Szczepanski,Private Prac.,Lublin

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

location_facility: Instit.of Gerontology na D.F.Chebotarev,Brain Vascular Path.

location_facility: Westside Medical Associates of Los Angeles

location_facility: Center of Clinical Neurology, private prac, Krakow

location_facility: Clinica Neurologica e Neurocirurgica de Joinvile

location_facility: Public Central Clinical Hosp,Neurology Clinic,Warsaw

location_facility: Tokyo Women's Medical University Hospital

location_facility: Instit.f.applicative Research in med.rehab.Dobrna

location_facility: Bakırkoy Dr. Sadi Konuk Egitim Ve Arastirma Hastanesi

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

location_facility: Nuovo Ospedale Civile S. Agostino-Estense

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: First Affiliated Hospital of Guangzhou University of TCM

location_facility: East Estonia Central Hospital, Neurology Dept, Ahtme

location_facility: The Affiliated Hospital of Hangzhou Normal University

location_facility: Univ. Hospital Bern, Neurology Dept, Stroke Center

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Zhytomyr Reg.ClinHosp na Gerbachevskiy RegCouncil,Neurol.Dep

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Reserch Institute for Brain and Blood Vessels Akita

location_facility: Instit.of Neurol,Psychiatry&Narcol,Vascul. Malformations Dep

location_facility: Shree Krishna Hospital and Research Centre

location_facility: Univ.Clin.Centr Gibinski of Silesian Med,Neurol.dep,Katowice

location_facility: City Clin.Emergency Hosp of Kursk, Neurology Department No.2

location_facility: RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH

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

location_facility: Univ. Debrecen Medical Health Science Center, Neurology Dept

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Bakirkoy Prof. Dr. Mazhar Osman Ruh Sagligi ve Sinir Hastaliklari

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: The Affiliated Hospital of Guizhou Medical University

location_facility: First Affiliated Hospital of Guangzhou Medical University

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Medical corporation Suiseikai Suiseikai Kajikawa Hospital

location_facility: KH d. Barmherzigen Brüder Linz, Neurologie

location_facility: Affiliated Hospital, Xuzhou Medical college

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden

location_facility: Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese

location_facility: The Second Affiliated Hospital to Nanchang University

location_facility: University Hosp. Zürich, Dept. of Neurology, Stroke Center

location_facility: Canton Hospital Aarau, Neurology Dept., Stroke Center

location_facility: CityClin.Hosp na I.V.Davydovsky of Dept of Healthcare Moscow

location_facility: Ltd liabilityCom.CityNeurologic Cntr Sibneiromed,Novosibirsk

location_facility: Ternopil State Med.Univ.na Gorbachevskiy,Neurology Dept N3

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: Beijing Tiantan Hospital affiliated to Cap Med University

location_facility: CHU de Quebec-Universite Laval Research Centre

location_facility: Hospital General Universitario de Albacete

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

location_facility: Veterans Affairs Portland Health Care System

location_facility: Hospital General de Culiacán "Dr. Bernardo J. Gastellum"

location_facility: Hospital de Braga - Centro Clínico Académico (2CA)

location_facility: National Hospital Organization Toyohashi Medical Center

location_facility: Special Hosp.for Cerebrovascul.Disease,'Sveti Sava,Belgrade

location_facility: Ospedale S.Maria della Misericordia, AO di Perugia

location_facility: North Estonia Medical Centre Foundation, Tallin

location_facility: Saint Alphonsus Medical Center-Neurology

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: Bukovinian Med.Univ.Chernivtsi Reg.Psychiatric Hosp,Neurolog

location_facility: Military Institute of Medicine Neurology Clinic, Warsaw

location_facility: The Duluth Clinic dba Essentia Health Duluth Clinic

location_facility: Krankenhaus der Barmherzigen Brüder Trier

location_facility: Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi

location_facility: CRU Hungary Ltd, Private Practice, Miskolc

location_facility: New York Presbyterian Hudson Valley Hospital


title: A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

summary: A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit.

ReferenceCitation: Schuster M, Zijlstra J, Casasnovas RO, Vermaat JSP, Kalakonda N, Goy A, Choquet S, Neste EVD, Hill B, Thieblemont C, Cavallo F, De la Cruz F, Kuruvilla J, Hamad N, Jaeger U, Caimi P, Gurion R, Warzocha K, Bakhshi S, Sancho JM, Follows G, Egyed M, Offner F, Vassilakopoulos T, Samal P, Ku M, Ma X, Corona K, Chamoun K, Shah J, Shacham S, Kauffman MG, Canales M, Maerevoet M. Effect of Prior Therapy and Disease Refractoriness on the Efficacy and Safety of Oral Selinexor in Patients with Diffuse Large B-cell Lymphoma (DLBCL): A Post-hoc Analysis of the SADAL Study. Clin Lymphoma Myeloma Leuk. 2022 Jul;22(7):483-494. doi: 10.1016/j.clml.2021.12.016. Epub 2021 Dec 25.

ReferenceCitation: Maerevoet M, Zijlstra JM, Follows G, Casasnovas RO, Vermaat JSP, Kalakonda N, Goy A, Choquet S, Van Den Neste E, Hill B, Thieblemont C, Cavallo F, De la Cruz F, Kuruvilla J, Hamad N, Jaeger U, Caimi P, Gurion R, Warzocha K, Bakhshi S, Sancho JM, Schuster M, Egyed M, Offner F, Vassilakopoulos TP, Samal P, Ku M, Ma X, Corona K, Chamoun K, Shah J, Shacham S, Kauffman MG, Canales M. Survival among patients with relapsed/refractory diffuse large B cell lymphoma treated with single-agent selinexor in the SADAL study. J Hematol Oncol. 2021 Jul 16;14(1):111. doi: 10.1186/s13045-021-01122-1.

ReferenceCitation: Shah J, Shacham S, Kauffman M, Daniele P, Tomaras D, Tremblay G, Casasnovas RO, Maerevoet M, Zijlstra J, Follows G, P Vermaat JS, Kalakonda N, Goy AH, Choquet S, Den Neste EV, Hill BT, Thieblemont C, Cavallo F, la Cruz F, Kuruvilla J, Hamad N, Bouabdallah R, Jäger U, Caimi P, Gurion R, Warzocha K, Bakhshi S, Sancho JM, Schuster M, Egyed M, Offner F, Vasilakopoulos TP, Samal P, Nagy A, Ku M, Canales Albendea MÁ. Health-related quality of life and utility outcomes with selinexor in relapsed/refractory diffuse large B-cell lymphoma. Future Oncol. 2021 Apr;17(11):1295-1310. doi: 10.2217/fon-2020-0946. Epub 2021 Feb 2.

ReferenceCitation: Kalakonda N, Maerevoet M, Cavallo F, Follows G, Goy A, Vermaat JSP, Casasnovas O, Hamad N, Zijlstra JM, Bakhshi S, Bouabdallah R, Choquet S, Gurion R, Hill B, Jaeger U, Sancho JM, Schuster M, Thieblemont C, De la Cruz F, Egyed M, Mishra S, Offner F, Vassilakopoulos TP, Warzocha K, McCarthy D, Ma X, Corona K, Saint-Martin JR, Chang H, Landesman Y, Joshi A, Wang H, Shah J, Shacham S, Kauffman M, Van Den Neste E, Canales MA. Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial. Lancet Haematol. 2020 Jul;7(7):e511-e522. doi: 10.1016/S2352-3026(20)30120-4.

ipd_sharing: Undecided

lead_sponsor: Karyopharm Therapeutics Inc

location_country:
Poland
Serbia
Spain
Greece
Austria
Australia
Italy
Canada
Netherlands
New Zealand
United Kingdom
Hungary
United States
France
India
Israel
Belgium
Germany
Bulgaria

location_facility: Martin-Luther-University Halle-Wittenberg Department of Oncology

location_facility: Semmelweis University Department of Medicine and Oncology

location_facility: Institute of Medical Sciences & SUM Hospital

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: University Hospitals Seidman Cancer Center

location_facility: National & Kapodistrian University of Athens, Laiko General Hospital

location_facility: Nil Ratan Sircar Medical College and Hospital

location_facility: Medical University of Vienna (MUW) Department of Medicine I

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: Hostpial Saint Louis - CIRCO (Centre d'Investigations et de Recherche Clinique en Oncologie)

location_facility: SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Maria Sklodowska Curie National Research Institute

location_facility: Gemeinschaftspraxis Haematologie and Onkologie-Dresden

location_facility: IRCH, All India Institute of Medical Sciences

location_facility: Klinikum Kempten Klinik für Innere Medizin III - Hämatologie, Onkologie und Palliativmedizin

location_facility: Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

location_facility: Netaji Subhas Chandra Bose Cancer Research Hospital

location_facility: Akh Linz Innere Med III - Zentrum für Hämatologie und med. Onkologie

location_facility: University Hospital for Active Treatment Dr. Georgi Stranski

location_facility: National & Kapodistrian University of Athens, Attiko University Hospital

location_facility: Virginia Mason Hospital & Medical Center

location_facility: Meenakshi Mission Hospital & Research Centre

location_facility: Sir Mortimer B Davis Jewish General Hospital/McGill University

location_facility: New York Presbyterian Hospital/ Cornell Medical College

location_facility: University of Massachusetts Medical School

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: Chu Dijon-Bourgogne - Hematologie Clinique

location_facility: Hematology Clinic,General Hospital of Athens,G. Gennimatos

location_facility: Hospitla Universitari Germans Trias i Pujol - ICO

location_facility: Hematology-Oncology & Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS

location_facility: LUMC (leidse universitair medisch centrum)

location_facility: Netaji Subhas Chandra Bose Cancer Research Institute

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: Specialized Hospital for Active Treatment of Haematological Diseases EAD

location_facility: Medizinische Universität Innsbruck für Innere Medizin

location_facility: Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences

location_facility: Liverpool Hospital, Ingham Institute of Medical Research

location_facility: Krankenhaus Barmherzigen Schwestern Linz

location_facility: Charite Universitatsmedizin Berlin (Virchow Campus)

location_facility: Hôpital Necker Service d'Hématologie Adult

location_facility: Princess Royal University Hospital (PRUH)

location_facility: Città della Salute e della Scienza di Torino

location_facility: Klinički centar Srbije Klinika za hematologiju

location_facility: Second Depth of Internal Medicine, Attiko University Hospital

location_facility: Hematology Department Laiko General Hospital

location_facility: Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital

location_facility: Haematology Department and HCT Unit G.Papanicolaou Hospital

location_facility: Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna

location_facility: Uni. Klinik für Innere Medizin III Universitätsklinikum der PMU LKH Salzburg

location_facility: Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika

location_facility: LKH Leoben Department for Haemato-Oncology

location_facility: Unite Hemopathies Lymphoides Chu Henri Mondor

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa

location_facility: Szpitale Wojewódzkie w Gdyni, Gdyńskie Centrum onkologii

location_facility: Hematology Department St John's Cancer Centre

location_facility: Memorial Provincial Specialist Hospital in Lodz

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

location_facility: AOU Maggiore della Carità SCDU Ematologia

location_facility: University of California Los Angeles (UCLA)

location_facility: Robert H. Lurie Comprehensive Cancer Center/Northwestern University

location_facility: Centrum Onkologii- Insytut Im. Marii Skłodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego

location_facility: Department of clinical hematology ,university hospital Ioannina

location_facility: Charite Universitatsmedizin Berlin (Benjamin Franklin Campus)

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Klinicko Bolnick Centar Zemun Odeljenje hematologije

location_facility: Boca Raton Cancer Research Medical Center

location_facility: Országos Onkológiai Intézet "A" Belgyógyászati Onkológiai Osztály

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza

location_facility: Institut za onkologiju i radiologiju Srbije

location_facility: Klinički centar Niš Klinika za hematologiju


title: An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia

summary: The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and activity of acalabrutinib in treating subjects with WM.

status: Active, not recruiting

ReferenceCitation: Owen RG, McCarthy H, Rule S, D'Sa S, Thomas SK, Tournilhac O, Forconi F, Kersten MJ, Zinzani PL, Iyengar S, Kothari J, Minnema MC, Kastritis E, Aurran-Schleinitz T, Cheson BD, Walter H, Greenwald D, Chen DY, Frigault MM, Hamdy A, Izumi R, Patel P, Wei H, Lee SK, Mittag D, Furman RR. Acalabrutinib monotherapy in patients with Waldenström macroglobulinemia: a single-arm, multicentre, phase 2 study. Lancet Haematol. 2020 Feb;7(2):e112-e121. doi: 10.1016/S2352-3026(19)30210-8. Epub 2019 Dec 19. Erratum in: Lancet Haematol. 2021 Apr;8(4):e249.

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

lead_sponsor: Acerta Pharma BV

location_country:
Spain
Italy
Greece
United Kingdom
United States
France
Netherlands


title: ADVATE/ ADYNOVI Hemophilia A Outcome Database

acronym: AHEAD

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

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

lead_sponsor: Baxalta now part of Shire

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

location_facility: South Metropolitan Health Service trading as Fiona Stanley Hospital

location_facility: Università degli studi di Roma "La Sapienza"

location_facility: Hospital Teresa Herrera-Materno Infantil

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

location_facility: Faculdade de Medicina da Universidade de São Paulo

location_facility: Fundación Oftalmológica de Santander FOSCAL

location_facility: Centro Hospitalar Lisboa Norte Hospital de Sta. Maria

location_facility: Landes Frauen und Kinderklinik Linz (LFKK Linz)

location_facility: IPS FUSA SAS Centro Integral de Coagulacion

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Centro Hospitalar e Universitade de Coimbra

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: CHU de Reims Hôpital Maison Blanche - CRTH

location_facility: Szpital Uniwersytecki nr 1 im. dr Andrzeja Jurasza

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Rikshospitalet, Oslo University Hospital

location_facility: Great Ormond Street Hospital for Children NHS Trust

location_facility: SBHI Chelyabinsk Regional Children's Clinical Hospital

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: Nanfang Hospital Affiliated to Nanfang Medical University

location_facility: Kliniska studier i Sverige - Forum Söder

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

location_facility: Uniwersytecki Szpital Kliniczny we Wrocławiu

location_facility: Centre Hospitalier Universitaire Vaudois

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

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

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

location_facility: Azienda Ospedaliera di Padova Clinica Medica II

location_facility: Hospital Universitari Vall d'Hebron (HUVH)

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

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

location_facility: Fakultní nemocnice Ostrava, Oddělení dětské hematologie a hematoonkologie

location_facility: Kepler Universitätsklinikum Klinik für Kinder-und Jugendheilkunde

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

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

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

location_facility: General Hospital of Thessaloniki "Ippokratio"

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

location_facility: FMH Kinder und Jugendmedizin, im Wabern-Zentrum

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

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

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

location_facility: Azienda Ospedaliera Policlinico Consorziale Di Bari

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

location_facility: Stollery Children's Hospital, University of Alberta


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

acronym: ESTEEM

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

lead_sponsor: Biogen

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

location_facility:
Research Sites
Research site
Research Site


acronym: MURANO

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

lead_sponsor: Hoffmann-La Roche

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

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

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

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

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

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

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

location_facility: LKH - Universitätsklinikum der PMU Salzburg

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

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

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Saskatoon City Hospital;Saskatchewan Cancer Centre

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

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

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

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

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: SP ZOZ Zespol Szpitali Miejskich w Chorzowie

location_facility: Perlmutter Cancer Center NYU Langone Health

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: University of California San Diego Medical Center

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

location_facility: Asst Grande Ospedale Metropolitano Niguarda; SC Farmacia Ospedale

location_facility: BHI of Omsk region Clinical Oncology Dispensary

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

location_facility: Cliniques Universitaires Saint-Luc; Hematology

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Huntsman Cancer Institute; University of Utah

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

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

location_facility: Leids Universitair Medisch Centrum; Cardiology

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

location_facility: Memorial Sloan Kettering Cancer Center; Clinical Trials Office

location_facility: Seoul National University Bundang Hospital

location_facility: Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

location_facility: Hospital Clinic i Provincial de Barcelona; Hematology

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

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


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

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

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

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

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

ReferenceCitation: Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0.

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

lead_sponsor: St. Anna Kinderkrebsforschung

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

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

location_facility: Cape of Hope, Wroclaw Medical University

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

location_facility: Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO

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

location_facility: University Hospital Gent Pediatrische hemato-oncologie

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

location_facility: Istituto Gaslini Genova Oncoematologia Pediatrica-

location_facility: Azienda Ospedaliera di Padova Oncoematologia Pediatrica

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum

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

location_facility: Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin

location_facility: CancerCare Manitoba/University of Manitoba

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

location_facility: Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti

location_facility: Uniklinik RWTH Aachen, Kinder- und Jugendmedizin

location_facility: Universitätsklinik für Kinder- und Jugendmedizin Tübingen

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

location_facility: Alberta Children's Hospital Division of Pediatric Oncology

location_facility: Schneider Children's Medical Center of Israel

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

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

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

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

location_facility: Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin

location_facility: University Hospitals Leuven Kinderhemato-oncologie

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

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

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde

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

location_facility: Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin

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

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

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

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

location_facility: Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin

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

location_facility: Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit

location_facility: Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin

location_facility: King Abdullah specialists children hospital

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

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

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

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

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

location_facility: Universitätsklinikum Erlangen, Kinder- und Jugendklinik

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

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

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

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

location_facility: Universitäts-Kinderspital beider Basel (UKBB)

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

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

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

location_facility: Universitätsklinikum Jena, Sektion für Stammzelltransplantation

location_facility: Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

location_facility: Princess Máxima Center for Pediatric Oncology

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

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

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

location_facility: The Children's Hospital at Westmead Oncology Unit

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

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

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

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

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

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

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

location_facility: Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie

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

location_facility: Universitätsklinikum Essen, Klinik für Kinderheilkunde III

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

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

location_facility: University of Malaya, Department of Paediatrics

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

location_facility: Saint Sophia Children's Hospital BMT Unit

location_facility: CHRU Lille, Service d'Hématologie Pédiatrique

location_facility: Hospital Universitario Central de Asturias

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

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

location_facility: Karolinska University Hospital, Department of Pediatrics

location_facility: CHU Nantes, Service d'onco hémato pédiatrie

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

location_facility: IInsitutul Clinic Fundeni, Sectia de Transplant Medular

location_facility: Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin

location_facility: CHU Sainte-Justine Hematology-Oncology Division

location_facility: Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit

intervention_type: Radiation


title: An Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat (EZH2 Histone Methyl Transferase [HMT] Inhibitor) as a Single Agent in Subjects With Advanced Solid Tumors or With B-cell Lymphomas and Tazemetostat in Combination With Prednisolone in Subjects With Diffuse Large B Cell Lymphoma

summary: This is a multicenter, open-label, Phase 1/2 study that is being conducted in two parts. The Phase 1 part (closed to accrual as of January 25, 2016) comprised dose escalation and expansion parts to establish the MTD and/or the recommended Phase 2 dose (RP2D) when tazemetostat was given BID (twice daily) orally on a continuous basis. Additionally, in separate cohorts in Phase 1, the effect of food on the bioavailability of tazemetostat as well as the drug-drug interaction (DDI) potential of tazemetostat were evaluated. The Phase 2 part was initiated once the MTD and /or RP2D was established. Phase 2 enrolls subjects with DLBCL (Cohorts 1-3 and 6) and FL (Cohorts 4 and 5) for the determination of efficacy and safety of tazemetostat monotherapy (Cohorts 1-5and of tazemetostat in combination with prednisolone (Cohort 6) with placement determined by centrally confirmed histology, cell of origin (COO), and EZH2 mutation status.

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

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

lead_sponsor: Epizyme, Inc.

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


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

acronym: ADJUNCT ONE™

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

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

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

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