An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML)

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

April 14, 2016

Primary Completion Date

September 4, 2019

Study Completion Date

July 23, 2021

Conditions
Myelodysplastic SyndromesLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Acute
Interventions
DRUG

Azacitidine

Azacitidine intravenous or subcutaneous formulation.

DRUG

Pevonedistat

Pevonedistat intravenous infusion.

Trial Locations (59)

24

Tallaght Hospital, Dublin

1113

University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD, Sofia

1756

Specialized Hospital for Active Treatment of Haematological Diseases - Sofia, Sofia

University Multi-Profile Hospital for Active Treatment Dr Georgi Stranski, Sofia

5500

Cliniques Universitaires UCL de Mont-Godinne, Yvoir

6000

Grand Hopital de Charleroi asbl, Charleroi

7010

Hospital Universitario Son Espases, Palma de Mallorca

8036

Hospital Clinic de Barcelona, Barcelona

8400

AZ Sint-Jan AV, Bruges

8916

Hospital Universitario Germans Trias i Pujol, Badalona

10021

Weill Cornell Medical College, New York

10032

Columbia University Medical Center, New York

10034

Fakultni Nemocnice Kralovske Vinohrady, Prague

10126

Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino, Torino

11042

Monter Cancer Center, Lake Success

13100

ZIV Medical Center, Safed

Tel Aviv Sourasky Medical Center, Tel Aviv

14603

University of Rochester Medical Center, Rochester

21287

Johns Hopkins University, Baltimore

22903

University of Virginia, Charlottesville

27599

University of North Carolina at Chapel Hill, Chapel Hill

28007

Hospital General Universitario Gregorio Maranon, Madrid

28046

Hospital Universitario La Paz, Madrid

28223

Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón

29010

Hospital Regional Universitario de Malaga - Hospital Universitario Virgen de la Victoria, Málaga

33136

University of Miami Miller School of Medicine, Miami

33612

H Lee Moffitt Cancer Center and Research Institute, Tampa

35233

University of Alabama, Birmingham

37007

Hospital Universitario de Salamanca, Salamanca

38700

CHU de GRENOBLE, Grenoble

40138

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Bologna

40479

Marien Hospital Akademisches Lehrkrankenhaus, Düsseldorf

44195

Cleveland Clinic, Cleveland

46010

Hospital Clinico Universitario de Valencia, Valencia

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

50139

Azienda Ospedaliera Universitaria Careggi, Florence

59000

CHRU Lille, Lille

60637

University of Chicago Medical Center, Chicago

72201

Greenville Health System, Little Rock

75010

Hopital Saint Louis, Paris

76712

Texas Oncology - Waco, TX, Tyler

77380

Nebraska Cancer Specialists, The Woodlands

78130

Cancer Care Center of South Texas, New Braunfels

80012

Rocky Mountain Cancer Centers, Aurora

87401

San Juan Oncology Associates, Farmington

89081

Universitatsklinikum Ulm, Ulm

89100

Azienda Ospedaliera Bianchi Melacrino Morelli, Reggio Calabria

92093

UC San Diego Moores Cancer Center, La Jolla

92501

Compassionate Cancer Care Medical Group Incorporated, Riverside

98902

Yakima Valley Memorial Hospital, Yakima

99208

Medical Oncology Associates, Spokane

9103102

Shaare Zedek Medical Center, Jerusalem

06510

Smilow Cancer Center at Yale New Haven Hospital, New Haven

M4N 3M5

Sunnybrook Health Science Centre, Toronto

M5G 2M9

Princess Margaret Hospital, Toronto

625 00

Fakultni Nemocnice Brno, Brno

Unknown

University Hospital Galway, Galway

6162 BG

Zuyderland Medisch Centrum, Sittard

08908

ICO I'Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet (ICO), Barcelona

All Listed Sponsors
lead

Millennium Pharmaceuticals, Inc.

INDUSTRY