Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

531

Participants

Timeline

Start Date

September 10, 2020

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Myelodysplastic Syndrome (MDS)
Interventions
DRUG

Venetoclax

Tablet: Oral

DRUG

Azacitidine

Subcutaneous (SC) or Intravenous (IV) injection

DRUG

Placebo

Tablet; Oral

Trial Locations (220)

704

National Cheng Kung University Hospital /ID# 218989, Tainan City

833

Duplicate_Kaohsiung Chang Gung Memorial Hospital /ID# 223573, Kaohsiung City

1090

Medizinische Universitaet Wien /ID# 221446, Vienna

1140

Hanusch Krankenhaus /ID# 221093, Vienna

1200

Cliniques Universitaires UCL Saint-Luc /ID# 219066, Brussels

2020

ZAS Middelheim /ID# 218907, Antwerp

2148

Duplicate_Blacktown Hospital /ID# 234079, Blacktown

2217

St George Hospital /ID# 221810, Kogarah

2444

Port Macquarie Base Hospital /ID# 234078, Port Macquarie

3000

Universitair Ziekenhuis Leuven /ID# 218905, Leuven

3065

St Vincent's Hospital Melbourne /ID# 221809, Fitzroy Melbourne

3084

Austin Health /ID# 221807, Heidelberg

4010

Ordensklinikum Linz GmbH Elisabethinen /ID# 221387, Linz

4032

Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 221702, Debrecen

4215

Gold coast University Hospital /ID# 222606, Southport

4400

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 221704, Nyíregyháza

4600

Klinikum Wels-Grieskirchen GmbH /ID# 221386, Wels

5000

Royal Adelaide Hospital /ID# 221805, Adelaide

5020

Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221092, Salzburg

5530

Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 219064, Yvoir

6720

Szegedi Tudományegyetem /ID# 221705, Szeged

7100

Hospital La Louviere Site Jolimont - Helora /ID# 218921, La Louvière

7400

Duplicate_Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 221703, Kaposvár

8000

AZ Sint-Jan Brugge /ID# 218212, Bruges

Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 222953, Székesfehérvár

9000

UZ Gent /ID# 218767, Ghent

10065

Weill Cornell Medical College /ID# 222898, New York

12203

Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189, Berlin

13005

Hopital de la Conception /ID# 224882, Marseille

13620

Seoul National University Bundang Hospital /ID# 221695, Seongnam-si

14004

Hospital Universitario Reina Sofia /ID# 221273, Córdoba

14222

University at Buffalo /ID# 221206, Buffalo

15232

UPMC Hillman Cancer Ctr /ID# 223201, Pittsburgh

20089

IRCCS Istituto Clinico Humanitas /ID# 220815, Rozzano

23219

Virginia Commonwealth University Medical Center Main Hospital /ID# 221590, Richmond

23230

Virginia Cancer Institute at Reynolds Crossing /ID# 221002, Richmond

27103

Novant Health Forsyth Medical Center /ID# 221004, Winston-Salem

28007

Hospital General Universitario Gregorio Maranon /ID# 221271, Madrid

28041

Hospital Universitario 12 de Octubre /ID# 221272, Madrid

28204

Novant Health Presbyterian Medical Center /ID# 222561, Charlotte

28223

Hospital Universitario Quironsalud Madrid /ID# 221275, Pozuelo de Alarcón

30625

Medizinische Hochschule Hannover /ID# 221173, Hanover

33401

Florida Cancer Specialists - East /ID# 221317, West Palm Beach

33604

Centre Hospitalier Universitaire de Bordeaux /ID# 220989, Pessac

33916

Florida Cancer Specialists - Fort Myers /ID# 221319, Fort Myers

34953

Acibadem Maslak Hastanesi /ID# 222072, Tuzla

37711

Hospital Universitario de Salamanca /ID# 221297, Salamanca

38030

Duplicate_Erciyes University Medical Fac /ID# 222090, Melikgazi

38700

CHU Grenoble - Hopital Michallon /ID# 220988, La Tronche

40138

IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 220810, Bologna

40225

Universitaetsklinikum Duesseldorf /ID# 221169, Düsseldorf

40447

China Medical University Hospital /ID# 218987, Taichung

41013

Hospital Universitario Virgen del Rocio /ID# 221276, Seville

44000

Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 222074, Nantes

46026

Hospital Universitario y Politecnico La Fe /ID# 221270, Valencia

48105

VA Ann Arbor Healthcare System /ID# 221365, Ann Arbor

49241

Duplicate_Pusan National University Hospital /ID# 232353, Busan

49503

Cancer & Hematology Centers /ID# 220848, Grand Rapids

50937

Universitaetsklinikum Koeln /ID# 234219, Cologne

55200

Ondokuz mayis University Facul /ID# 222091, Samsun

55416

Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 221321, Saint Louis Park

57105

Avera Cancer Institute /ID# 243461, Sioux Falls

59037

CHRU Lille - Hopital Claude Huriez /ID# 220991, Lille

60426

Ingalls Memorial Hosp /ID# 220844, Harvey

60612

Duplicate_Rush University Medical Center /ID# 221007, Chicago

61615

Illinois Cancer Care, PC /ID# 220840, Peoria

64132

MidAmerica Division, Inc. /ID# 221895, Kansas City

67214

Cancer Center of Kansas /ID# 222648, Wichita

68167

Universitatsklinikum Mannheim /ID# 221172, Mannheim

70809

Hematology/Oncology Clinic /ID# 224257, Baton Rouge

71004

Chi-Mei Medical Center /ID# 218991, Tainan City

73557

Stauferklinikum Schwaebisch Gmuend /ID# 224917, Mutlangen

75010

Hôpital Saint-Louis /ID# 222075, Paris

75230

Duplicate_Texas Oncology - Medical City Dallas /ID# 223725, Dallas

75702

Texas Oncology - Northeast Texas /ID# 223734, Tyler

76038

Centre Henri Becquerel /ID# 220986, Rouen

78240

Texas Oncology - San Antonio Medical Center - Research Drive /ID# 223728, San Antonio

78705

Texas Oncology - Austin Midtown /ID# 223729, Austin

80131

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816, Naples

80303

Rocky Mountain Cancer Centers - Boulder /ID# 223723, Boulder

81675

Klinikum rechts der Isar /ID# 221170, Munich

84106

Utah Cancer Specialists Salt Lake Clinic /ID# 219160, Salt Lake City

84902

CH Henri Duffaut /ID# 225185, Avignon

89125

Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 220818, Reggio Calabria

90095

University of California, Los Angeles /ID# 221760, Los Angeles

91031

Shaare Zedek Medical Center /ID# 233181, Jerusalem

91120

Hadassah Medical Center-Hebrew University /ID# 222006, Jerusalem

92835

Duplicate_Providence Medical Foundation /ID# 222633, Fullerton

97701

Bend Memorial Clinic /ID# 220999, Bend

102206

Peking University International Hospital /ID# 222987, Beijing

110022

Shengjing Hospital of China Medical University /ID# 222945, Shenyang

127644

Hospital n.a. V.V. Veresaev /ID# 225435, Moscow

129301

MMCC Kommunarka /ID# 221213, Moscow

185019

Republican hospital named after V.A. Baranov /ID# 221214, Petrozavodsk

197341

Almazov National Medical Research Centre /ID# 221449, Saint Petersburg

200233

Shanghai Sixth People's Hospital /ID# 221546, Shanghai

210009

Zhongda Hospital Southeast University /ID# 221849, Nanjing

210029

Jiangsu Province Hospital /ID# 221342, Nanjing

215031

The First Affiliated Hospital of Soochow University /ID# 221640, Suzhou

248007

Kaluga Regional Clinical Hospital /ID# 221211, Kaluga

300020

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567, Tianjin

300052

Tianjin Medical University General Hospital /ID# 226810, Tianjin

310003

The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 221494, Hangzhou

310020

Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 225982, Hangzhou

322000

The Fourth Affiliated Hospital Zhejiang University School of Medicine /ID# 225918, Yiwu

330006

The First Affiliated Hospital of Nanchang University /ID# 225983, Nanchang

357502

Clinic UZI 4D /ID# 221215, Pyatigorsk

430022

Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 221475, Wuhan

430030

Tongji Hospital Tongji Medical College of HUST /ID# 221474, Wuhan

450003

People's Hospital of Henan Province /ID# 225790, Zhengzhou

450008

Henan Cancer Hospital /ID# 221447, Zhengzhou

510080

Guangdong Provincial People's Hospital /ID# 221442, Guangzhou

510280

Zhujiang Hospital of Southern Medical University /ID# 222071, Guangzhou

510515

Nanfang Hospital of Southern Medical University /ID# 224566, Guangzhou

610041

West China Hospital, Sichuan University /ID# 221601, Chengdu

710054

Shaanxi Provincial People'S Hospital /ID# 225728, Xi'an

730030

Lanzhou University Second Hospital /ID# 225980, Lanzhou

3109601

Rambam Health Care Campus /ID# 221083, Haifa

4941492

Rabin Medical Center /ID# 221184, Petah Tikva

5265601

The Chaim Sheba Medical Center /ID# 221110, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center /ID# 221896, Tel Aviv

9808574

Tohoku University Hospital /ID# 221976, Sendai

90505-5004

Torrance Memorial Physician Network Cancer Care /ID# 222702, Torrance

90602-1006

PIH Health Whittier Hospital /ID# 222647, Whittier

06510

Yale University School of Medicine /ID# 222764, New Haven

19713-2055

Helen F. Graham Cancer Center & Research Institute /ID# 223731, Newark

33021-3513

Memorial Healthcare System /ID# 222703, Hollywood

33705-1449

Florida Cancer Specialists - North /ID# 221318, St. Petersburg

32308-5304

Florida Cancer Specialists - Panhandle /ID# 221315, Tallahassee

83712-6267

St. Luke's Mountain State Tumor Institute /ID# 220838, Boise

60611-2927

Northwestern University Feinberg School of Medicine /ID# 220843, Chicago

46845-1739

Duplicate_Parkview Cancer Institute /ID# 223620, Fort Wayne

70433-7512

Pontchartrain Cancer Center - Covington /ID# 221005, Covington

21044-3128

Maryland Oncology Hematology /ID# 223776, Columbia

02114

Massachusetts General Hospital /ID# 225068, Boston

02215-5400

Beth Israel Deaconess Medical Center /ID# 225069, Boston

02215

Dana-Farber Cancer Institute /ID# 219162, Boston

89052-2648

Comprehensive Cancer Centers of Nevada - Horizon Ridge /ID# 222635, Henderson

08816

Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 221003, East Brunswick

07652

The Valley Hospital /ID# 232337, Paramus

12206-5013

New York Oncology Hematology - Albany Cancer Center /ID# 223778, Albany

11794-8183

Stony Brook University Hospital /ID# 224450, Stony Brook

45236-2725

Oncology Hematology Care, Inc. /ID# 223724, Cincinnati

97401-6043

Willamette Valley Cancer Institute and Research Center /ID# 223733, Eugene

37404-3230

Tennessee Oncology - Chattanooga / McCallie /ID# 221311, Chattanooga

37203-1632

Tennessee Oncology-Nashville Centennial /ID# 220854, Nashville

75246-2003

Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727, Dallas

76104-2150

Texas Oncology - Forth Worth /ID# 223777, Fort Worth

77030-4000

MD Anderson Cancer Center at Texas Medical Center /ID# 219163, Houston

76508-0001

Baylor Scott & White Medical Center- Temple /ID# 221332, Temple

20155-3257

Virginia Cancer Specialists - Gainesville /ID# 223726, Gainesville

98108-1597

VA Puget Sound Health Care System /ID# 221358, Seattle

60430-372

Hospital Universitario Walter Cantidio /ID# 223434, Fortaleza

81520-060

Hospital Erasto Gaertner /ID# 221341, Curitiba

05652-900

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 221370, São Paulo

20551-030

Hospital Universitário Pedro Ernesto /ID# 223080, Rio de Janeiro

05403-000

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 221339, São Paulo

V3V 1Z2

BC Cancer - Surrey /ID# 219098, Surrey

K1H 8L6

Ottawa Hospital Research Institute /ID# 219105, Ottawa

M4N 3M5

Sunnybrook Health Sciences Centre /ID# 219103, Toronto

H4A 3J1

McGill University Health Centre - Glen Site /ID# 222519, Montreal

H4J 1C5

CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973, Montreal

G1J 1Z4

CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200, Québec

050000

The Second Hospital of Hebei Medical University /ID# 222919, Shijiazhuang

625 00

Fakultní Nemocnice Brno - Jihlavská /ID# 221351, Brno

500 05

Fakultní nemocnice Hradec Králové - Sokolská /ID# 221163, Hradec Králové

708 52

Fakultni Nemocnice Ostrava /ID# 219143, Ostrava

323 00

Fakultní Nemocnice Plzeň-Lochotín /ID# 221162, Pilsen

128 00

Všeobecná Fakultní Nemocnice v Praze /ID# 221229, Prague

Ustav hematologie a krevni transfuze /ID# 221350, Prague

06202

Chu de Nice-Hopital L'Archet Ii /Id# 220992, Nice

04103

Universitaetsklinikum Leipzig /ID# 221168, Leipzig

00189

Duplicate_Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819, Rome

466-8560

Nagoya University Hospital /ID# 221566, Nagoya

910-1104

University of Fukui Hospital /ID# 221568, Yoshida-gun

812-8582

Kyushu University Hospital /ID# 223473, Fukuoka

960-1295

Fukushima Medical University Hospital /ID# 222015, Fukushima

720-0001

Chugoku Central Hospital /ID# 222955, Fukuyama

003-0006

Sapporo Hokuyu Hospital /ID# 222133, Sapporo

064-0804

Aiiku Hospital /ID# 222351, Sapporo

650-0047

Kobe City Medical Center General Hospital /ID# 221977, Kobe

311-3193

NHO Mito Medical Center /ID# 222278, Higashiibaraki-gun

701-1192

Okayama Medical Center /ID# 222310, Okayama

589-8511

Kindai University Hospital /ID# 222284, Osakasayama-shi

350-8550

Saitama Medical Center /ID# 222016, Kawagoe

141-8625

NTT Medical Center Tokyo /ID# 222365, Shinagawa-ku

990-9585

Yamagata University Hospital /ID# 221574, Yamagata

852-8501

Nagasaki University Hospital /ID# 222241, Nagasaki

6229 HX

Maastricht Universitair Medisch Centrum /ID# 221630, Maastricht

5631 BM

Maxima Medisch Centrum /ID# 223010, Eindhoven

7512 KZ

Medisch Spectrum Twente /ID# 223012, Enschede

8025 AB

Isala /ID# 223011, Zwolle

3015 CE

Erasmus Medisch Centrum /ID# 218937, Rotterdam

85-168

Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321, Bydgoszcz

20-081

Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 221667, Lublin

01-748

Lux Med Onkologia - Szpital Szamocka /Id# 222203, Warsaw

02-172

MTZ Clinical Research Powered by Pratia /ID# 221354, Warsaw

80-214

Uniwersyteckie Centrum Kliniczne /ID# 222069, Gdansk

40-519

Pratia Onkologia Katowice /ID# 224728, Katowice

93-513

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221784, Lodz

00935

Pan American Center for Oncology Trials, LLC /ID# 221010, Rio Piedras

00921-3201

VA Caribbean Healthcare System /ID# 221012, San Juan

03080

Seoul National University Hospital /ID# 221226, Seoul

05505

Asan Medical Center /ID# 221227, Seoul

06351

Samsung Medical Center /ID# 221224, Seoul

03722

Yonsei University Health System Severance Hospital /ID# 233171, Seoul

08916

Hospital Universitario Germans Trias i Pujol /ID# 221274, Badalona

08035

Hospital Universitario Vall d'Hebron /ID# 221323, Barcelona

06100

Hacettepe University Faculty of Medicine /ID# 222094, Ankara

06800

Ankara City Hospital /ID# 222093, Ankara

07059

Akdeniz Universitesi Tip Fakul /ID# 222095, Antalya

PL6 8DH

Derriford Hospital and the Royal Eye Infirmary /ID# 222514, Plymouth

BH15 2JB

University Hospitals Dorset NHS Foundation Trust /ID# 221237, Poole

NW1 2BU

University College London Hospital /ID# 221240, London

OX3 9DU

Oxford University Hospitals NHS Foundation Trust /ID# 221231, Oxford

CF14 4XN

Cardiff & Vale University Health Board /ID# 221236, Cardiff

AB15 6RE

NHS Grampian /ID# 222509, Aberdeen

B15 2TH

University Hospitals Birmingham NHS Foundation Trust /ID# 221233, Birmingham

BS1 3NU

University Hospitals Bristol /ID# 222510, Bristol

SW3 6JJ

The Royal Marsden NHS Foundation Trust /ID# 221232, London

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

AbbVie

INDUSTRY