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)

PHASE2CompletedINTERVENTIONAL
Enrollment

213

Participants

Timeline

Start Date

June 3, 2016

Primary Completion Date

December 31, 2018

Study Completion Date

December 27, 2021

Conditions
Leukemia, Myeloid, AcuteMyelodysplastic Syndromes
Interventions
DRUG

Azacitidine

Administered by subcutaneous injection on Days 1 to 7 of each 4-week treatment cycle.

BIOLOGICAL

Durvalumab

Administered by intravenous infusion on Day 1 of every 4-week treatment cycle.

Trial Locations (103)

133

Azienda Ospedaliera Bianchi-Melacrino-Morelli, Roma

Local Institution - 303, Roma

Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Rome

Local Institution - 304, Rome

1090

AKH Wien, Wein

1140

Hanusch Krankenhaus der Stadt Wien, Vienna

Local Institution - 653, Vienna

1200

Cliniques Universitaires St-Luc, Brussels

1307

Klinikum der LMU Campus Grosshadern, München

Local Institution - 605, München

3000

UH Gasthuisberg, Leuven

4020

Elisabethinen Hospital Linz, Linz

4200

Hospital de Sao Joao, Porto

5020

Salzburger Landkliniken St. Johanns-Spital, Salzburg

5530

Cliniques Universitaires UCL de Mont-Godine, Yvoir

6000

Grand Hopital de Charleroi, Charleroi

6020

Medizinische Universitat Innsbruck, Innsbruck

7198

Hospital Son Llatzer, Palma de Mallorca

8036

Medizinische Universitat Graz, Graz

Hospital Clinic I Provincial de Barcelona, Barcelona

9000

Local Institution - 202, Ghent

UH Gent, Ghent

10003

Complejo Hospitalario San Pedro de Alcantara, Cáceres

10029

Icahn School of Medicine at Mount Sinai, New York

14263

Roswell Park Cancer Institute, Buffalo

20007

Georgetown University Hospital, Washington D.C.

20162

Ospedale Niguarda Milano, Milan

21100

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

25123

AO Spedali Civili di Brescia, Brecia

27100

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

Local Institution - 302, Pavia

27705

Duke University Medical Center, Durham

28006

Hospital Universitario La Princesa, Madrid

28040

Hospital Universitario Vall D hebron, Barcelona

29010

Hospital Universitario Virgen de la Victoria, Málaga

30174

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

30625

Medizinische Hochschule HannoverZentrum Innere Medizin, Hanover

32610

University of Florida, Gainesville

33100

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Palermo

33604

CHU Bordeaux, Pessac

Local Institution - 254, Pessac

33612

Moffitt Cancer Center, Tampa

37007

Hospital Gregorio Maranon, Madrid

Local Institution - 555, Madrid

Hospital Universitario de Salamanca, Salamanca

37203

Vanderbilt University Medical Center, Nashville

38700

Centre Hospitalier Universitaire de Grenoble Hopital Albert Michallon, La Tronche

40479

Local Institution - 603, Düsseldorf

Marien Hospital, Düsseldorf

41013

Hospital Virgen del Rocio, Seville

44093

CHRU de Nantes - Hotel Dieu, Nantes

45122

Universitatsklinikum Essen, Essen

46009

Hospital Universitario La Fe, Valencia

Local Institution - 559, Valencia

46010

Hospital Clinico Universitario de Valencia, Valencia

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

57105

Avera Cancer Institute, Sioux Falls

60590

Klinikum der Johann Wolfgang Goethe Universitat, Frankfurt am Main

60637

University of Chicago, Chicago

67091

Centre Hospitalier Universitaire d' Angers, Angers

69008

Centre Leon Berard, Lyon

Local Institution - 261, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

75010

Hopital Saint Louis, Paris

Local Institution - 251, Paris

77230

University of Texas- MD Anderson, Houston

79106

Universitatsklinikum Freiburg, Freiburg im Breisgau

81675

Klinikum rechts der Isar der TU Munchen, München

89081

Universitatsklinikum Ulm, Ulm

89100

Policlinico Agostino Gemelli - Istituto di Ematologia, Roma

93009

Hopital Avicenne, Bobigny

94010

Hopital Henri Mondor, Créteil

06520

Yale Cancer Center, New Haven

07601

Hackensack University Medical Center, Hackensack

T6g2b7

University of Alberta, Edmonton

R3E 0V9

CancerCare Manitoba, Winnipeg

E2L 4L2

Saint John Regional Hospital, Saint John

K1H 8L6

Ottawa General Hospital, Ottawa

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H2L 4M1

CHUM - Notre Dame, Montreal

31059 Cedex 9

IUCT Oncopole, Toulouse

01307

Local Institution - 604, Dresden

Universitatsklinikum Carl Gustav Carus, Dresden

04103

Universitatsklinikum Leipzig, Leipzig

1081 HV

VU University Medical Center, Amsterdam

36-200

Oddzial Hematologii Onkologicznej Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologicz, Brzozów

80-211

Katedra i Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne, Gdansk

20-081

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

10-228

Oddzial Hematologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW, Olsztyn

50-367

Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku, Wroclaw

3000-076

Hospitais da Universidade de Coimbra, Coimbra

1099-023

Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE, Lisbon

4200-072

Ipo Instituto Portugues De Oncologia Porto, Porto

Local Institution - 502, Porto

B15 2TH

University Hospital Birmingham, Birmingham

LS1 3EX

St James University Hospital, Leeds

EC1 7BE

St Bartholomews Hospital, London

SE5 9RS

Kings College Hospital, London

WC1E 6AU

University College London Hospital, London Bloomsbury

M20 4BX

The Christie NHS Foundation Trust, Manchester

OX3 9DU

John Radcliffe Hospital, Oxford

Local Institution - 453, Oxford

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

NCT02775903 - 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) | Biotech Hunter | Biotech Hunter