Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)

PHASE3CompletedINTERVENTIONAL
Enrollment

454

Participants

Timeline

Start Date

November 28, 2017

Primary Completion Date

May 28, 2021

Study Completion Date

October 14, 2024

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

Azacitidine

Azacitidine intravenous or subcutaneous formulation.

DRUG

Pevonedistat

Pevonedistat intravenous infusion.

Trial Locations (242)

1200

Cliniques Universitaires Saint-Luc, Brussels

1307

Universitatsklinikum Carl Gustav Carus an der TU Dresden, Dresden

1871

Liverpool Hospital, Liverpool

2930

Algemeen Ziekenhuis Klina, Brasschaat

3000

UZ Leuven, Leuven

4032

Icon Cancer Care Chermside, Chermside

4066

Icon Cancer Care Wesley, Auchenflower

4101

Icon Cancer Care South Brisbane, South Brisbane

Icon Cancer Care, South Brisbane

4103

Universitatsklinikum Leipzig, Leipzig

4215

Icon Cancer Care Southport, Southport

5505

Asan Medical Center - PPDS, Seoul

5530

CHU UCL Namur asbl - Site Godinne, Yvoir

6351

Samsung Medical Center - PPDS, Seoul

6500

Gazi University Medical Faculty Gazi Hospital, Ankara

6591

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

7000

Royal Hobart Hospital, Hobart

8000

AZ Sint-Jan AV, Bruges

8035

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

8907

ICO lHospitalet Hospital Duran i Reynals, LHospitalet de Llobregat

10021

Weill Cornell Medical Center - Monitoring Location, New York

Weill Cornell Medical Center, New York

10126

Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino, Torino

11527

Athens General Hospital 'G Gennimatas', Athens

Laiko General Hospital of Athens, Athens

12462

Attikon University General Hospital, Athens

13100

ZIV Medical Center, Safed

14033

Hopital Cote de Nacre, Caen

14642

Strong Memorial Hospital, Rochester

18015

St. Luke's Hospital, Bethlehem

18045

St. Luke's University Health Network, Easton

20010

Medstar Research Institute, Washington D.C.

20089

Istituto Clinico Humanitas, Rozzano

22903

University of Virginia, Charlottesville

24014

Oncology and Hematology Associates of Southwest Virginia (Roanoke) - USOR, Roanoke

24060

Oncology and Hematology Associates of Southwest Virginia (Blacksburg) - USOR, Blacksburg

24071

Complejo Asistencial Universitario de Leon, León

24153

Oncology and Hematology Associates of Southwest Virginia Inc, Salem

24382

Oncology and Hematology Associates of Southwest Virginia, Wytheville

24457

Oncology and Hematology Associates of Southwest Virginia (Low Moor) - USOR, Low Moor

25123

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN, Brescia

26504

University General Hospital of Patras, Pátrai

27599

University of North Carolina at Chapel Hill, Chapel Hill

28006

Hospital Universitario de La Princesa, Madrid

28009

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28046

Hospital Universitario La Paz - PPDS, Madrid

29307

Greenville Health System, Spartanburg

29605

Greenville Health System, Greenville

29615

Greenville Health System Cancer Institute, Greenville

29640

Greenville Health System, Easley

29650

Greenville Health System, Greer

29672

Greenville Health System, Seneca

30322

Winship Cancer Institute, Emory University, Atlanta

32159

Florida Cancer Specialists - NORTH - SCRI - PPDS, The Villages

32224

Mayo Clinic Jacksonville - PPDS, Jacksonville

32605

Florida Cancer Specialists - NORTH - SCRI - PPDS, Gainesville

32701

Florida Cancer Specialists - NORTH - SCRI - PPDS, Altamonte Springs

32763

Florida Cancer Specialists - NORTH - SCRI - PPDS, Orange City

32778

Florida Cancer Specialists - NORTH - SCRI - PPDS, Tavares

32792

Florida Cancer Specialists - NORTH - SCRI - PPDS, Winter Park

32806

Florida Cancer Specialists - NORTH - SCRI - PPDS, Orlando

33136

University of Miami Miller School of Medicine, Miami

33176

Baptist Health System (N Kendall) - USOR, Miami

33331

Cleveland Clinic Florida, Weston

33343

Mersin University Medical Faculty, Mersin

33511

Florida Cancer Specialists - NORTH - SCRI - PPDS, Brandon

33607

Florida Cancer Specialists - NORTH - SCRI - PPDS, Tampa

33705

Florida Cancer Specialists - NORTH - SCRI - PPDS, St. Petersburg

33761

Florida Cancer Specialists - NORTH - SCRI - PPDS, Clearwater

33770

Florida Cancer Specialists - NORTH - SCRI - PPDS, Largo

33905

SCRI Florida Cancer Specialists South, Fort Myers

33908

SCRI Florida Cancer Specialists South, Fort Myers

33914

SCRI Florida Cancer Specialists South, Cape Coral

33916

SCRI Florida Cancer Specialists South, Fort Myers

33980

SCRI Florida Cancer Specialists South, Port Charlotte

34102

SCRI Florida Cancer Specialists South, Naples

34135

SCRI Florida Cancer Specialists South, Bonita Springs

34209

SCRI Florida Cancer Specialists South, Bradenton

34232

SCRI Florida Cancer Specialists South, Sarasota

34236

SCRI Florida Cancer Specialists South, Sarasota

34285

SCRI Florida Cancer Specialists South, Venice

34292

SCRI Florida Cancer Specialists South, Venice

34461

Florida Cancer Specialists - NORTH - SCRI - PPDS, Lecanto

34471

Florida Cancer Specialists - NORTH - SCRI - PPDS, Ocala

34608

Florida Cancer Specialists - NORTH - SCRI - PPDS, Spring Hill

34655

Florida Cancer Specialists - NORTH - SCRI - PPDS, New Port Richey

35100

Ege University Medical Faculty, Izmir

36526

Southern Cancer Center - USOR, Daphne

36607

Southern Cancer Center - USOR, Mobile

36608

Southern Cancer Center - USOR, Mobile

Southern Cancer Center- USOR, Mobile

37007

Complejo Asistencial Universitario de Salamanca - H. Clinico, Salamanca

37055

Tennessee Oncology - DICKSON - SCRI - PPDS, Dickson

37066

Tennessee Oncology - GALLATIN - SCRI - PPDS, Gallatin

37067

Tennessee Oncology - FRANKLIN - SCRI - PPDS, Franklin

37076

Tennessee Oncology - SUMMIT - SCRI - PPDS, Hermitage

37090

Tennessee Oncology - LEBANON - SCRI - PPDS, Lebanon

37129

Tennessee Oncology - MURFREESBORO - SCRI - PPDS, Murfreesboro

37160

Tennessee Oncology - SHELBYVILLE - SCRI - PPDS, Shelbyville

37167

Tennessee Oncology - SMYRNA - SCRI - PPDS, Smyrna

37203

Sarah Cannon Center for Blood Centers - SCRI - PPDS, Nashville

Tennessee Oncolgy - BAPTIST - SCRI - PPDS, Nashville

Tennessee Oncology NASH - SCRI - PPDS, Nashville

37205

Tennessee Oncology - ST THOMAS WEST - SCRI - PPDS, Nashville

37207

Tennessee Oncology SKYLINE - SCRI - PPDS, Nashville

37211

Tennessee Oncology - SOUTHERN HILLS - SCRI - PPDS, Nashville

40138

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

40479

Marien Hospital Akademisches Lehrkrankenhaus, Düsseldorf

41110

University General Hospital of Larissa, Larissa

41944

Kyungpook National University Hospital, Daegu

44111

Fairview Hospital, Cleveland

44124

Hillcrest Hospital Cancer Care Center, Mayfield

44195

The Cleveland Clinic Foundation, Cleveland

45014

Oncology Hematology Care, Inc - Fairfield, Fairfield

45211

Oncology Hematology Care, Inc., Cincinnati

45230

Oncology Hematology Care, Inc., Cincinnati

45236

Oncology Hematology Care Inc - USOR, Cincinnati

45242

Oncology Hematology Care Inc - USOR, Cincinnati

45500

University General Hospital of Ioannina, Ioannina

46010

Hospital Clinico Universitario de Valencia, Valencia

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

49100

CHU Angers, Angers

49241

Pusan National University Hospital, Busan

50134

Azienda Ospedaliera Universitaria Careggi, Florence

52787

Hematologica Alta Especialidad S.C., Huixquilucan

55139

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi, Samsun

57010

Georgios Papanikolaou General Hospital of Thessaloniki, Thessaloniki

58100

Edith Wolfson Medical Center, Holon

58128

Chonnam National University Hwasun Hospital, Jeongnam

59100

Namik Kemal University, Tekirdağ

60612

Rush University Medical Center, Chicago

61080

Karadeniz Technical University Faculty of Medicine, Trabzon

64057

Centerpoint Medical Center, Independence

64132

HCA Midwest Health - SCRI - PPDS, Kansas City

Research Medical Center, Kansas City

64239

Tel Aviv Sourasky Medical Center PPDS, Tel Aviv

66209

Menorah Medical Center, Overland Park

68100

University Hospital of Alexandroupolis, Alexandroupoli

68130

Nebraska Cancer Specialists, Omaha

72076

Universitatsklinikum Tubingen, Tübingen

74000

Centre Hospitalier Le Mans, Le Mans

75010

Hopital Saint Louis, Paris

75230

Texas Oncology (Medical City) - USOR, Dallas

75246

Baylor Sammons Cancer Center, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

75475

Hopital Saint Louis, Paris

75601

Texas Oncology (Tyler) - USOR, Longview

75702

Texas Oncology (Tyler) - USOR, Tyler

78130

Texas Oncology (E Common) - USOR, New Braunfels

78240

Texas Oncology - San Antonio Medical Center - USOR, San Antonio

78681

Texas Oncology (Round Rock) - USOR, Round Rock

78705

Texas Oncology (West 38) - USOR, Austin

78731

Texas Oncology (Balcones) - USOR, Austin

78745

Texas Oncology (James Casey) - USOR, Austin

80012

Rocky Mountain Cancer Centers (Aurora) - USOR, Aurora

80112

Laboratory Corporation of America, Englewood

80120

Rocky Mountain Cancer Centers (Littleton) - USOR, Littleton

80124

Rocky Mountain Cancer Centers (Lone Tree) - USOR, Lone Tree

80138

Rocky Mountain Cancer Centers (Parker) - USOR, Parker

80209

Quest Diagnostics, INC, Denver

80218

Colorado Blood Cancer Institute - PPDS, Denver

Presbyterian Saint Lukes Medical Center Laboratory, Denver

Presbyterian/St. Luke's Medical Center, Denver

Rocky Mountain Cancer Centers (Williams) - USOR, Denver

80220

Rocky Mountain Cancer Centers (Denver) - USOR, Denver

80228

Rocky Mountain Cancer Centers (Lakewood) - USOR, Lakewood

80239

Kaiser Foundation Health Plan, Denver

80260

Rocky Mountain Cancer Centers (Thornton) - USOR, Thornton

80303

Rocky Mountain Cancer Centers (Boulder) - USOR, Boulder

80501

Rocky Mountain Cancer Centers (Longmont) - USOR, Longmont

80907

Rocky Mountain Cancer Centers (Colorado Springs) - USOR, Colorado Springs

81008

Rocky Mountain Cancer Centers (Pueblo) - USOR, Pueblo

83605

Saint Alphonsus Caldwell Cancer Care Center, Caldwell

83687

Saint Alphonsus Medical Center, Nampa

83706

Saint Alphonsus Regional Medical Center, Boise

85028

IRCCS Centro Di Riferimento Oncologico Della Basilicata, Rionero in Vulture

85338

Southeastern Regional Medical Center - CTCA - PPDS, Goodyear

85704

Arizona Oncology Associates (Orange HOPE) - USOR, Tucson

Arizona Oncology Associates (Rudasill HOPE) - USOR, Tucson

85711

Arizona Oncology Associates (Wilmot HOPE) - USOR, Tucson

91031

Shaare Zedek Medical Center, Jerusalem

91120

Hadassah Medical Center PPDS -, Jerusalem

92093

UC San Diego Moores Cancer Center, La Jolla

92373

Emad Ibrahim, MD, Inc, Redlands

92501

Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc, Riverside

92708

Compassionate Cancer Care Medical Group Inc, Fountain Valley

92879

Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc, Corona

100053

Xuanwu Hospital Capital Medical University, Beijing

129301

City Clinical Hospital # 40, Moscow

191024

Russian Research Institute of Hematology and Blood Transfusion, Saint Petersburg

197341

North-West Federal Medical Research Center n.a. V.A. Almazov, Saint Petersburg

300020

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin

3508550

Saitama Medical Center, Kawagoe

8528102

Nagasaki University Hospital, Nagasaki

08724

New Jersey Hematology Oncology Associates LLC, Brick

07601

John Theurer Cancer Center, Hackensack

08755

New Jersey Hematology and Oncology, Toms River

81520-060

Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner, Curitiba

59075-740

Liga Norte Riograndense Contra O Cancer, Natal

88034-000

Centro de Pesquisas Oncologicas, Florianópolis

90035-903

Hospital de Clinicas de Porto Alegre (HCPA) - PPDS, Porto Alegre

21941-913

Universidade Federal do Rio de Janeiro - UFRJ, Rio de Janeiro

08270-120

Hospital Santa Marcelina, São Paulo

08270-270

Hospital Santa Marcelina, São Paulo

T2N 4

Tom Baker Cancer Centre, Calgary

T6G 2B7

University of Alberta, Edmonton

T6G1Z1

Kaye Edmonton Clinic, Edmonton

E2L 4L2

Saint John Regional Hospital, Saint John

M4N3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2M9

Princess Margaret Hospital, Toronto

M5G2M9

Princess Margaret Hospital, Toronto

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

128 08

Vseobecna Fakultni Nemocnice V Praze, Prague

115 27

Laiko General Hospital of Athens, Athens

Unknown

Galilee Medical Center, Nahariya

Capital Humano para Investigacion Clinica SC, México

720-0001

Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital, Fukuyama

060 8638

Hokkaido University Hospital, Sapporo

960-1295

Fukushima Medical University Hospital, Fukushima

650-0047

Kobe City Medical Center General Hospital, Kobe

602-8566

University Hospital, Kyoto Prefectural University of Medicine, Kyoto

589-8511

Kindai University Hospital, Sayama

113-8431

Juntendo University Hospital, Bunkyo

141-8625

NTT Medical Center Tokyo, Shinagawa-ku

812-8582

Kyushu University Hospital, Fukuoka

321-0293

Dokkyo Medical University Hospital, Mibu

545-8586

Osaka Metropolitan University Hospital, Osaka

232-0024

Yokohama City University Hospital, Yokohama

910-1193

University of Fukui Hospital, Yoshida-gun

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

80-214

Uniwersyteckie Centrum Kliniczne, Klinika Hematologii I Transplantologii, Budynek Centrum Medycyny N, Gdansk

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

20-090

Centrum Onkologii Ziemi Lubelskiej, Lublin

45-061

Zaklad Diagnostyki Obrazowej SOR, Opole

45-372

Szpital Wojewodzki w Opolu, Opole

25-734

Swietokrzyskie Centrum Onkologii, Kielce

BH7 7DW

Royal Bournemouth Hospital, Bournemouth

ME16 9QQ

Maidstone Hospital, Maidstone

EC1A 7BE

St Bartholomew's Hospital, London

SA2 8QA

Singleton Hospital - PPDS, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Takeda Development Center Americas, Inc.

INDUSTRY

lead

Takeda

INDUSTRY

NCT03268954 - Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) | Biotech Hunter | Biotech Hunter