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Spots Global Cancer Trial Database for An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)

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Trial Identification

Brief Title: An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)

Official Title: A Randomized, Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)

Study ID: NCT02775903

Study Description

Brief Summary: The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who are not eligible for HSCT or in adults ≥ 65 years old with previously untreated AML who are not eligible for HSCT, with intermediate or poor cytogenetic risk.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Yale Cancer Center, New Haven, Connecticut, United States

Georgetown University Hospital, Washington, District of Columbia, United States

University of Florida, Gainesville, Florida, United States

Moffitt Cancer Center, Tampa, Florida, United States

University of Chicago, Chicago, Illinois, United States

Hackensack University Medical Center, Hackensack, New Jersey, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Icahn School of Medicine at Mount Sinai, New York, New York, United States

Duke University Medical Center, Durham, North Carolina, United States

Avera Cancer Institute, Sioux Falls, South Dakota, United States

Vanderbilt University Medical Center, Nashville, Tennessee, United States

University of Texas- MD Anderson, Houston, Texas, United States

Medizinische Universitat Graz, Graz, , Austria

Medizinische Universitat Innsbruck, Innsbruck, , Austria

Elisabethinen Hospital Linz, Linz, , Austria

Salzburger Landkliniken St. Johanns-Spital, Salzburg, , Austria

AKH Wien, Wein, , Austria

Hanusch Krankenhaus der Stadt Wien, Wien, , Austria

Local Institution - 653, Wien, , Austria

Cliniques Universitaires St-Luc, Brussels, , Belgium

Grand Hopital de Charleroi, Charleroi, , Belgium

Local Institution - 202, Gent, , Belgium

UH Gent, Gent, , Belgium

UH Gasthuisberg, Leuven, , Belgium

Cliniques Universitaires UCL de Mont-Godine, Yvoir, , Belgium

University of Alberta, Edmonton, Alberta, Canada

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Saint John Regional Hospital, Saint John, New Brunswick, Canada

Ottawa General Hospital, Ottawa, Ontario, Canada

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

CHUM - Notre Dame, Montreal, Quebec, Canada

Centre Hospitalier Universitaire d' Angers, Angers, , France

Hopital Avicenne, Bobigny Cedex, , France

Hopital Henri Mondor, Creteil, , France

Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon, La Tronche, , France

Centre Leon Berard, Lyon, , France

Local Institution - 261, Lyon, , France

CHRU de Nantes - Hotel Dieu, Nantes, , France

Hopital Saint Louis, Paris, , France

Local Institution - 251, Paris, , France

CHU Bordeaux, Pessac, , France

Local Institution - 254, Pessac, , France

Centre Hospitalier Lyon Sud, Pierre-Bénite Cedex, , France

IUCT Oncopole, Toulouse, , France

Local Institution - 604, Dresden, , Germany

Universitatsklinikum Carl Gustav Carus, Dresden, , Germany

Local Institution - 603, Dusseldorf, , Germany

Marien Hospital, Dusseldorf, , Germany

Universitatsklinikum Essen, Essen, , Germany

Klinikum der Johann Wolfgang Goethe Universitat, Frankfurt am Main, , Germany

Universitatsklinikum Freiburg, Freiburg, , Germany

Medizinische Hochschule HannoverZentrum Innere Medizin, Hannover, , Germany

Universitatsklinikum Leipzig, Leipzig, , Germany

Klinikum der LMU Campus Grosshadern, Munchen, , Germany

Local Institution - 605, Munchen, , Germany

Klinikum rechts der Isar der TU Munchen, Munchen, , Germany

Universitatsklinikum Ulm, Ulm, , Germany

AO Spedali Civili di Brescia, Brecia, , Italy

Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy

Ospedale Niguarda Milano, Milano, , Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Palermo, , Italy

I.R.C.C.S. Policlinico San Matteo - Universita di Pavia, Pavia, , Italy

Local Institution - 302, Pavia, , Italy

Azienda Ospedaliera Bianchi-Melacrino-Morelli, Roma, , Italy

Local Institution - 303, Roma, , Italy

Policlinico Agostino Gemelli - Istituto di Ematologia, Roma, , Italy

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Rome, , Italy

Local Institution - 304, Rome, , Italy

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine, Udine, , Italy

Universita degli Studi dell'Insubria - Ospedale di Circolo e Fondazione Macchi - Varese, Varese, , Italy

VU University Medical Center, Amsterdam, , Netherlands

Oddzial Hematologii Onkologicznej Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologicz, Brzozow, , Poland

Katedra i Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku, Lubin, , Poland

Oddzial Hematologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW, Olsztyn, , Poland

Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku, Wroclaw, , Poland

Hospitais da Universidade de Coimbra, Coimbra, , Portugal

Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE, Lisbon, , Portugal

Ipo Instituto Portugues De Oncologia Porto, Porto, , Portugal

Local Institution - 502, Porto, , Portugal

Hospital de Sao Joao, Porto, , Portugal

Hospital Universitario Vall D hebron, Barcelona, , Spain

Hospital Clinic I Provincial de Barcelona, Barcelona, , Spain

Complejo Hospitalario San Pedro de Alcantara, Caceres, , Spain

Hospital Universitario La Princesa, Madrid, , Spain

Hospital Gregorio Maranon, Madrid, , Spain

Local Institution - 555, Madrid, , Spain

Hospital Universitario Virgen de la Victoria, Malaga, , Spain

Hospital Son Llatzer, Palma de Mallorca, , Spain

Hospital Universitario de Salamanca, Salamanca, , Spain

Hospital Virgen del Rocio, Sevilla, , Spain

Hospital Universitario La Fe, Valencia, , Spain

Local Institution - 559, Valencia, , Spain

Hospital Clinico Universitario de Valencia, Valencia, , Spain

University Hospital Birmingham, Birmingham, , United Kingdom

St James University Hospital, Leeds, , United Kingdom

University College London Hospital, London Bloomsbury, , United Kingdom

St Bartholomews Hospital, London, , United Kingdom

Kings College Hospital, London, , United Kingdom

The Christie NHS Foundation Trust, Manchester, , United Kingdom

John Radcliffe Hospital, Oxford, , United Kingdom

Local Institution - 453, Oxford, , United Kingdom

The Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom

Contact Details

Name: CL Beach, Pharm D

Affiliation: Celgene Corporation

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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