A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

443

Participants

Timeline

Start Date

February 2, 2017

Primary Completion Date

December 1, 2021

Study Completion Date

January 23, 2026

Conditions
Acute Myeloid Leukemia (AML)
Interventions
DRUG

Azacitidine

Solution for subcutaneous or intravenous administration.

DRUG

Venetoclax

Tablet

DRUG

Placebo

Matching placebo tablet

Trial Locations (172)

100

National Taiwan University Hospital /ID# 153900, Taipei

807

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 153902, Kaohsiung City

1085

Semmelweis Egyetem /ID# 153816, Budapest

1088

Duplicate_Semmelweis Egyetem /ID# 153815, Budapest

1090

UZ Brussel /ID# 153393, Jette

1097

Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 158990, Budapest

1140

Hanusch Krankenhaus /ID# 155676, Vienna

1200

UCL Saint-Luc /ID# 153391, Woluwe-Saint-Lambert

1474

Akershus universitetssykehus /ID# 154279, Nordlenangen

1714

Sykehuset Ostfold Kalnes /ID# 157755, Grålum

3004

Alfred Health /ID# 154275, Melbourne

Drammen Sykehus /ID# 154280, Drammen

3050

The Royal Melbourne Hospital /ID# 155095, Parkville

3065

St Vincent's Hospital Melbourne /ID# 155094, Melbourne

3100

Universitaetsklinikum St. Poelten /ID# 167436, Sankt Pölten

4010

Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888, Linz

Ordensklinikum Linz GmbH Elisabethinen /ID# 154885, Linz

4032

Debreceni Egyetem Klinikai Kozpont /ID# 153814, Debrecen

4102

Princess Alexandra Hospital /ID# 154272, Woolloongabba

4400

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 169854, Nyíregyháza

5000

Royal Adelaide Hospital /ID# 154271, Adelaide

5020

Duplicate_Landeskrankenhaus Salzburg /ID# 169719, Salzburg

5021

Haukeland University Hospital /ID# 154281, Bergen

6000

Royal Perth Hospital /ID# 154274, Perth

6009

Sir Charles Gairdner Hospital /ID# 163924, Nedlands

6725

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 153812, Szeged

7400

Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813, Kaposvár

8000

AZ Sint-Jan Brugge /ID# 154041, Bruges

8036

Medizinische Universitaet Graz /ID# 157882, Graz

9000

UZ Gent /ID# 153392, Ghent

Aalborg University Hospital /ID# 154047, Aalborg

10000

Clinical Hospital Dubrava /ID# 153515, Zagreb

Klinicki bolnicki centar Zagreb /ID# 153383, Zagreb

15260

University of Pittsburgh MC /ID# 154102, Pittsburgh

16132

Ospedale Policlinico San Martino /ID# 158104, Genova

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882, Milan

20246

Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 153056, Hamburg

20520

Turku University Hospital /ID# 154964, Turku

21287

Johns Hopkins University /ID# 154104, Baltimore

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 152875, Bergamo

28006

Hospital Universitario de la Princesa /ID# 153256, Madrid

28007

Hospital General Universitario Gregorio Maranon /ID# 153260, Madrid

28041

Hospital Universitario 12 de Octubre /ID# 153258, Madrid

29010

Hospital Universitario Virgen de la Victoria /ID# 153257, Málaga

30322

Emory Midtown Infectious Disease Clinic /ID# 162534, Atlanta

30625

Medizinische Hochschule Hannover /ID# 153055, Hanover

31000

Duplicate_Klinicki bolnicki centar Osijek /ID# 153623, Osijek

31008

Hospital Universitario de Navarra /ID# 153254, Pamplona

31059

IUCT Oncopole /ID# 153788, Toulouse

33520

Tampere University Hospital /ID# 154963, Tampere

33604

CHU Bordeaux - Hopital Haut Leveque /ID# 153789, Pessac

36011

Poltava Reg Clin Hosp Sklifoso /ID# 153513, Poltava

40138

IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 152883, Bologna

40447

China Medical University Hospital /ID# 153904, Taichung

46026

Hospital Universitario y Politecnico La Fe /ID# 153259, Valencia

46804

Fort Wayne Medical Oncology /ID# 157190, Fort Wayne

48149

Universitaetsklinikum Muenster /ID# 153059, Münster

49102

Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 153511, Dnipro

49503

Sepctrum Health Medical Center /ID# 159522, Grand Rapids

49933

Chu Angers /Id# 153792, Angers

50006

Changhua Christian Hospital /ID# 153899, Changhua

55139

Ondokuz Mayis Universitesi Tip /ID# 155201, Samsun

60126

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 171220, Ancona

60590

Universitaetsklinikum Frankfurt /ID# 153060, Frankfurt am Main

66606

Cotton-O'Neil Clinical Res Ctr /ID# 155136, Topeka

70300

Assaf Harofeh Medical Center /ID# 158063, Be’er Ya‘aqov

73100

Presidio Ospedaliero Vito Fazzi /ID# 170837, Lecce

75010

AP-HP - Hopital Saint-Louis /ID# 153787, Paris

77030

University of Texas MD Anderson Cancer Center /ID# 154100, Houston

80131

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 152879, Napoli

89081

Universitaetsklinikum Ulm /ID# 153054, Ulm

89124

Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 152877, Reggio Calabria

90095

University of California, Los Angeles /ID# 154107, Los Angeles

91010

City of Hope /ID# 154105, Duarte

91120

Hadassah /ID# 154172, Jerusalem

95817

University of California, Davis Comprehensive Cancer Center /ID# 162725, Sacramento

125167

Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 155740, Moscow

125284

Moscow State budget healthcare /ID# 155738, Moscow

130021

The First Hospital of Jilin University /ID# 167490, Changchun

200065

Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 167318, Shanghai

210029

Jiangsu Province Hospital /ID# 167489, Nanjing

250012

Qilu Hospital of Shandong University /ID# 167485, Jinan

300020

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 167487, Tianjin

310006

The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 167317, Hangzhou

350001

Fujian Medical University Union Hospital /ID# 167314, Fuzhou

390039

State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 157460, Ryazan

410012

Saratov State Medical University n.a. V.I. Razumovskiy /ID# 153267, Saratov

430022

Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167315, Wuhan

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167493, Wuhan

440071

Duplicate_Regional Oncology Dispensary /ID# 153264, Penza

443099

Samara State Medical University /ID# 157462, Samara

450008

Henan Cancer Hospital /ID# 167320, Zhengzhou

510515

Nanfang Hospital of Southern Medical University /ID# 170148, Guangzhou

603126

Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 153268, Nizhny Novgorod

610041

West China Hospital, Sichuan University /ID# 167492, Chengdu

650099

Kuzbass Regional Clinical Hospital /ID# 157461, Kemerovo

3109601

Rambam Health Care Campus /ID# 154174, Haifa

4941492

Rabin Medical Center /ID# 154176, Petah Tikva

5265601

The Chaim Sheba Medical Center /ID# 154173, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center /ID# 154175, Tel Aviv

9808574

Tohoku University Hospital /ID# 169259, Sendai

60611-2927

Northwestern University Feinberg School of Medicine /ID# 201133, Chicago

60637-1426

University of Chicago Medicine /ID# 154108, Chicago

40202-3700

Norton Cancer Institute /ID# 154992, Louisville

04412

EMMC Cancer Care /ID# 154991, Brewer

02114

Massachusetts General Hospital /ID# 200752, Boston

02215-5400

Beth Israel Deaconess Medical Center /ID# 201155, Boston

02215

Dana-Farber Cancer Institute /ID# 167009, Boston

10032-3725

Columbia Univ Medical Center /ID# 154101, New York

10065-6007

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077, New York

27710-3000

Duke Cancer Center /ID# 154106, Durham

37203-1632

Tennessee Oncology-Nashville Centennial /ID# 200854, Nashville

76508-0001

Baylor Scott & White Medical Center- Temple /ID# 157191, Temple

84112-5500

University of Utah /ID# 157192, Salt Lake City

05405

University Of Vermont Medical /ID# 157196, Burlington

90035-903

Hospital de Clinicas de Porto Alegre /ID# 157779, Porto Alegre

14051-140

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 153099, Ribeirão Preto

01236-030

Instituto de Ensino e Pesquisa São Lucas /ID# 157778, São Paulo

01246-000

Instituto do Câncer do Estado de São Paulo - ICESP /ID# 153095, São Paulo

T2N 4N2

Tom Baker Cancer Centre /ID# 159645, Calgary

V6Z 1Y6

St. Paul's Hospital /ID# 159644, Vancouver

L8V 1C3

Juravinski Cancer Centre /ID# 153650, Hamilton

K1H 8L6

Ottawa Hospital Research Institute /ID# 153541, Ottawa

M5G 2M9

Princess Margaret Cancer Centre /ID# 153651, Toronto

050000

The Second Hospital of Hebei Medical University /ID# 167316, Shijiazhuang

625 00

Fakultni Nemocnice Brno /ID# 154019, Brno

500 05

Fakultni nemocnice Hradec Kralove /ID# 154021, Hradec Králové

708 52

Fakultni nemocnice Ostrava /ID# 154017, Ostrava

305 99

Fakultni nemocnice Plzen /ID# 154018, Pilsen

00290

Helsinki University Hospital /ID# 155223, Helsinki

06120

Universitaetsklinikum Halle (Saale) /ID# 153058, Halle

00133

Fondazione PTV Policlinico Tor Vergata /ID# 152881, Rome

00189

Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 152876, Rome

464-8681

Aichi Cancer Center Hospital /ID# 200824, Nagoya

910-1193

University of Fukui Hospital /ID# 167432, Yoshida-gun

811-1395

National Hospital Organization Kyushu Cancer Center /ID# 201111, Fukuoka

812-8582

Kyushu University Hospital /ID# 169095, Fukuoka

371-0821

Gunmaken Saiseikai Maebashi Hospital /ID# 168316, Maebashi

311-3193

National Hospital Organization Mito Medical Center /ID# 168219, Higashi

317-0077

Hitachi General Hospital /ID# 201109, Hitachi-shi

602-8566

Duplicate_Kyoto Prefectural University of Medicine /ID# 167661, Kyoto

852-8501

Nagasaki University Hospital /ID# 168632, Nagasaki

700-8558

Okayama University Hospital /ID# 204124, Okayama

545-8586

Osaka Metropolitan University Hospital /ID# 169055, Osaka

589-8511

Duplicate_Kindai University Hospital /ID# 167662, Osaka-sayama-shi

350-1298

Saitama Medical University International Medical Center /ID# 167814, Hidaka-shi

113-8431

Juntendo University Hospital /ID# 168309, Bunkyo-ku

113-8677

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 168639, Bunkyo-ku

201-8601

The Jikei University Daisan Hospital /ID# 168745, Komae-shi

141-8625

NTT Medical Center Tokyo /ID# 167975, Shinagawa-ku

990-9585

Yamagata University Hospital /ID# 167634, Yamagata

31-826

Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym im. Ludwika Rydygiera w /ID# 169846, Krakow

50-556

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153389, Wroclaw

41-500

SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 153385, Chorzów

4710-423

Duplicate_Hospital de Braga /ID# 154797, Braga

4200-072

IPO Porto FG, EPE /ID# 154138, Porto

00921-3201

VA Caribbean Healthcare System /ID# 160507, San Juan

0001

University of Pretoria /ID# 153682, Pretoria

0044

Albert Alberts Stem Cell Transplant Centre /ID# 153684, Pretoria

05030

Duplicate_Konkuk University Medical Ctr /ID# 153973, Seoul

03080

Seoul National University Hospital /ID# 153675, Seoul

06351

Samsung Medical Center /ID# 153674, Seoul

08036

Hospital Clinic de Barcelona /ID# 153255, Barcelona

08041

Hospital Santa Creu i Sant Pau /ID# 153193, Barcelona

751 85

Akademiska Sjukhuset /ID# 153034, Uppsala

451 80

Uddevalla sjukhus /ID# 156875, Uddevalla

221 85

Dup_VO Hematologi /ID# 153174, Lund

171 76

Karolinska University Hospital /ID# 170003, Stockholm

06100

Hacettepe University Faculty of Medicine /ID# 202073, Ankara

06620

Ankara Universitesi Fakultesi /ID# 155200, Ankara

04112

Kyiv city clinical hospital #9 /ID# 153510, Kiev

04107

Kyiv Regional Onco Dispensary /ID# 153514, Kyiv

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

AbbVie

INDUSTRY