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
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