Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes

PHASE2CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

July 6, 2015

Primary Completion Date

June 19, 2019

Study Completion Date

September 14, 2023

Conditions
Myelodysplastic Syndromes
Interventions
DRUG

Oral Azacitidine

Oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.

DRUG

Durvalumab

Durvalumab 1500 mg by IV infusion on Day 1 of each 28 day treatment cycle.

Trial Locations (89)

1070

Hopital Erasme, Brussels

Local Institution - 802, Brussels

1090

Local Institution - 801, Brussels

Universitair Ziekenhuis Brussel, Brussels

1340

Clinique Saint-Pierre, Ottignies

2145

Westmead Hospital, Westmead

3144

Cabrini Hospital, Malvern

Local Institution - 405, Malvern

3168

Local Institution - 400, Clayton

Monash Medical Centre, Clayton

4000

Centre Hospitalier Universitaire de Liege, Liège

Local Institution - 800, Liège

4029

Royal Brisbane and Women's Hospital, Herston

5000

Local Institution - 401, Adelaide

Royal Adelaide Hospital, Adelaide

6000

Royal Perth Hospital, Perth

8035

Hospital Universitari Vall d'Hebron, Barcelona

10029

Icahn School of Medicine at Mount Sinai, New York

Local Institution - 101, New York

13273

Institut Paoli Calmettes, Marseille

15100

Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo, Allessandria

15232

Hillman Cancer Institute at UPMC, Pittsburgh

18014

Hospital Virgenes de las Nieves, Granada

Local Institution - 300, Granada

19104

Local Institution - 110, Philadelphia

University of Pennsylvania, Philadelphia

20132

Ospedale San Raffaele S.r.l., Milan

28009

Hospital General Gregorio Maranon, Madrid

Local Institution - 307, Madrid

29010

Hospital Universitario Virgen De La Victoria, Málaga

31059

CHU Purpan, Toulouse

33006

Hospital Central de Asturias, Oviedo

Local Institution - 303, Oviedo

33136

University of Miami Miller School of Medicine, Miami

33612

H Lee Moffitt Cancer Center and Research Institute, Tampa

Local Institution - 104, Tampa

37007

Hospital Universitario de Salamanca, Salamanca

Local Institution - 304, Salamanca

40138

Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi, Bologna

40202

James Graham Brown Cancer Center, Louisville

Local Institution - 103, Louisville

40479

Local Institution - 502, Düsseldorf

Marien Hospital, Düsseldorf

41013

Hospital Universitario Virgen Del Rocio, Seville

Local Institution - 308, Seville

46009

CEIC Hospital Universitario La Fe, Valencia

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

Local Institution - 601, Florence

52242

Local Institution - 116, Iowa City

University of Iowa Hospitals and Clinics, Iowa City

53226

Medical College of Wisconsin, Milwaukee

60637

Local Institution - 111, Chicago

University of Chicago Medicine, Chicago

75010

Hopital Saint-Louis, Paris

Local Institution - 201, Paris

77030

University of Texas- MD Anderson, Houston

78229

Cancer Care Centers of South Texas - HOAST, San Antonio

79106

Universitatsklinikum Freiburg, Freiburg im Breisgau

81377

Medizinische Klinik III Klinikum der Universität München-Großhadern, München

06520

Local Institution - 113, New Haven

Yale University, New Haven

60426-3558

Ingalls Memorial Hospital, Harvey

Local Institution - 109, Harvey

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

Local Institution - 102, Hackensack

L8V1C3

Local Institution - UNK-004, Hamilton

D-01307

Local Institution - 500, Dresden

Universitatsklinikum Carl Gustav Carus an der TU Dresden, Dresden

06120

Universitatsklinikum Halle Saale, Halle

04103

Universitatsklinikum Leipzig, Leipzig

00189

Azienda Ospedaliera Sant Andrea, Roma

Local Institution - 603, Roma

10-228

Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii, Olsztyn

02-106

Local Institution - 900, Warsaw

MTZ Clinical Research Sp. z o.o., Warsaw

50-367

Uniwersytecki Szpital Kliniczny, Wroclaw

08907

Institut Calatà d'Oncologia, L'Hospitalet, Barcelona

Local Institution - 306, Barcelona

PE21 9QS

Local Institution - 701, Boston

United Lincolnshire Hospitals NHS Trust, Boston

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge

CM17ET

Broomfield Hospital, Chelmsford

LS1 3EX

Saint James University Hospital, Leeds

SE5 9RS

King's College HospitalSchool of Medicine, London

Local Institution - 700, London

W12 0HS

Hammersmith Hospital, London

WC1E 6BT

University College London, London

HA1 3UJ

Northwick Park Hospital, Middlesex

SO16 6YD

Southampton General Hospital, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

NCT02281084 - Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes | Biotech Hunter | Biotech Hunter