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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
Sponsor: AbbVie
Summary
Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed. Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own. This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are \>= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants. In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine. Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.
Official title: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
443
Start Date
2017-02-02
Completion Date
2026-01-23
Last Updated
2025-08-19
Healthy Volunteers
No
Conditions
Interventions
Azacitidine
Solution for subcutaneous or intravenous administration.
Venetoclax
Tablet
Placebo
Matching placebo tablet
Locations (172)
City of Hope /ID# 154105
Duarte, California, United States
University of California, Los Angeles /ID# 154107
Los Angeles, California, United States
University of California, Davis Comprehensive Cancer Center /ID# 162725
Sacramento, California, United States
Emory Midtown Infectious Disease Clinic /ID# 162534
Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine /ID# 201133
Chicago, Illinois, United States
University of Chicago Medicine /ID# 154108
Chicago, Illinois, United States
Fort Wayne Medical Oncology /ID# 157190
Fort Wayne, Indiana, United States
Cotton-O'Neil Clinical Res Ctr /ID# 155136
Topeka, Kansas, United States
Norton Cancer Institute /ID# 154992
Louisville, Kentucky, United States
EMMC Cancer Care /ID# 154991
Brewer, Maine, United States
Johns Hopkins University /ID# 154104
Baltimore, Maryland, United States
Massachusetts General Hospital /ID# 200752
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 201155
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 167009
Boston, Massachusetts, United States
Sepctrum Health Medical Center /ID# 159522
Grand Rapids, Michigan, United States
Columbia Univ Medical Center /ID# 154101
New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077
New York, New York, United States
Duke Cancer Center /ID# 154106
Durham, North Carolina, United States
University of Pittsburgh MC /ID# 154102
Pittsburgh, Pennsylvania, United States
Tennessee Oncology-Nashville Centennial /ID# 200854
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center /ID# 154100
Houston, Texas, United States
Baylor Scott & White Medical Center- Temple /ID# 157191
Temple, Texas, United States
University of Utah /ID# 157192
Salt Lake City, Utah, United States
University Of Vermont Medical /ID# 157196
Burlington, Vermont, United States
Princess Alexandra Hospital /ID# 154272
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital /ID# 154271
Adelaide, South Australia, Australia
Alfred Health /ID# 154275
Melbourne, Victoria, Australia
St Vincent's Hospital Melbourne /ID# 155094
Melbourne, Victoria, Australia
The Royal Melbourne Hospital /ID# 155095
Parkville, Victoria, Australia
Sir Charles Gairdner Hospital /ID# 163924
Nedlands, Western Australia, Australia
Royal Perth Hospital /ID# 154274
Perth, Western Australia, Australia
Universitaetsklinikum St. Poelten /ID# 167436
Sankt Pölten, Lower Austria, Austria
Medizinische Universitaet Graz /ID# 157882
Graz, Styria, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888
Linz, Upper Austria, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 154885
Linz, Upper Austria, Austria
Duplicate_Landeskrankenhaus Salzburg /ID# 169719
Salzburg, Austria
Hanusch Krankenhaus /ID# 155676
Vienna, Austria
UZ Brussel /ID# 153393
Jette, Brussels Capital, Belgium
UCL Saint-Luc /ID# 153391
Woluwe-Saint-Lambert, Brussels Capital, Belgium
UZ Gent /ID# 153392
Ghent, Oost-Vlaanderen, Belgium
AZ Sint-Jan Brugge /ID# 154041
Bruges, Belgium
Hospital de Clinicas de Porto Alegre /ID# 157779
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 153099
Ribeirão Preto, São Paulo, Brazil
Instituto de Ensino e Pesquisa São Lucas /ID# 157778
São Paulo, São Paulo, Brazil
Instituto do Câncer do Estado de São Paulo - ICESP /ID# 153095
São Paulo, São Paulo, Brazil
Tom Baker Cancer Centre /ID# 159645
Calgary, Alberta, Canada
St. Paul's Hospital /ID# 159644
Vancouver, British Columbia, Canada
Juravinski Cancer Centre /ID# 153650
Hamilton, Ontario, Canada
Ottawa Hospital Research Institute /ID# 153541
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre /ID# 153651
Toronto, Ontario, Canada
Fujian Medical University Union Hospital /ID# 167314
Fuzhou, Fujian, China
Nanfang Hospital of Southern Medical University /ID# 170148
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University /ID# 167316
Shijiazhuang, Hebei, China
Henan Cancer Hospital /ID# 167320
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167315
Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167493
Wuhan, Hubei, China
Jiangsu Province Hospital /ID# 167489
Nanjing, Jiangsu, China
The First Hospital of Jilin University /ID# 167490
Changchun, Jilin, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 167318
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University /ID# 167492
Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 167487
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 167317
Hangzhou, Zhejiang, China
Qilu Hospital of Shandong University /ID# 167485
Jinan, China
Clinical Hospital Dubrava /ID# 153515
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 153383
Zagreb, City of Zagreb, Croatia
Duplicate_Klinicki bolnicki centar Osijek /ID# 153623
Osijek, County of Osijek-Baranja, Croatia
Fakultni Nemocnice Brno /ID# 154019
Brno, Czechia
Fakultni nemocnice Hradec Kralove /ID# 154021
Hradec Králové, Czechia
Fakultni nemocnice Ostrava /ID# 154017
Ostrava, Czechia
Fakultni nemocnice Plzen /ID# 154018
Pilsen, Czechia
Aalborg University Hospital /ID# 154047
Aalborg, North Denmark, Denmark
Tampere University Hospital /ID# 154963
Tampere, Pirkanmaa, Finland
Helsinki University Hospital /ID# 155223
Helsinki, Uusimaa, Finland
Turku University Hospital /ID# 154964
Turku, Finland
CHU Bordeaux - Hopital Haut Leveque /ID# 153789
Pessac, Gironde, France
Chu Angers /Id# 153792
Angers, France
AP-HP - Hopital Saint-Louis /ID# 153787
Paris, France
IUCT Oncopole /ID# 153788
Toulouse, France
Universitaetsklinikum Ulm /ID# 153054
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Frankfurt /ID# 153060
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Muenster /ID# 153059
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum Halle (Saale) /ID# 153058
Halle, Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 153056
Hamburg, Germany
Medizinische Hochschule Hannover /ID# 153055
Hanover, Germany
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 153812
Szeged, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 153814
Debrecen, Hajdú-Bihar, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 169854
Nyíregyháza, Nyiregyhaza, Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813
Kaposvár, Somogy County, Hungary
Semmelweis Egyetem /ID# 153816
Budapest, Hungary
Duplicate_Semmelweis Egyetem /ID# 153815
Budapest, Hungary
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 158990
Budapest, Hungary
The Chaim Sheba Medical Center /ID# 154173
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 154175
Tel Aviv, Tel Aviv, Israel
Assaf Harofeh Medical Center /ID# 158063
Be’er Ya‘aqov, Israel
Rambam Health Care Campus /ID# 154174
Haifa, Israel
Hadassah /ID# 154172
Jerusalem, Israel
Rabin Medical Center /ID# 154176
Petah Tikva, Israel
Presidio Ospedaliero Vito Fazzi /ID# 170837
Lecce, Apulia, Italy
Fondazione PTV Policlinico Tor Vergata /ID# 152881
Rome, Roma, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 171220
Ancona, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 152875
Bergamo, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 152883
Bologna, Italy
Ospedale Policlinico San Martino /ID# 158104
Genova, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882
Milan, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 152879
Naples, Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 152877
Reggio Calabria, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 152876
Rome, Italy
Aichi Cancer Center Hospital /ID# 200824
Nagoya, Aichi-ken, Japan
University of Fukui Hospital /ID# 167432
Yoshida-gun, Fukui, Japan
National Hospital Organization Kyushu Cancer Center /ID# 201111
Fukuoka, Fukuoka, Japan
Kyushu University Hospital /ID# 169095
Fukuoka, Fukuoka, Japan
Gunmaken Saiseikai Maebashi Hospital /ID# 168316
Maebashi, Gunma, Japan
National Hospital Organization Mito Medical Center /ID# 168219
Higashi, Ibaraki, Japan
Hitachi General Hospital /ID# 201109
Hitachi-shi, Ibaraki, Japan
Duplicate_Kyoto Prefectural University of Medicine /ID# 167661
Kyoto, Kyoto, Japan
Tohoku University Hospital /ID# 169259
Sendai, Miyagi, Japan
Nagasaki University Hospital /ID# 168632
Nagasaki, Nagasaki, Japan
Okayama University Hospital /ID# 204124
Okayama, Okayama-ken, Japan
Osaka Metropolitan University Hospital /ID# 169055
Osaka, Osaka, Japan
Duplicate_Kindai University Hospital /ID# 167662
Osaka-sayama-shi, Osaka, Japan
Saitama Medical University International Medical Center /ID# 167814
Hidaka-shi, Saitama, Japan
Juntendo University Hospital /ID# 168309
Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 168639
Bunkyo-ku, Tokyo, Japan
The Jikei University Daisan Hospital /ID# 168745
Komae-shi, Tokyo, Japan
NTT Medical Center Tokyo /ID# 167975
Shinagawa-ku, Tokyo, Japan
Yamagata University Hospital /ID# 167634
Yamagata, Yamagata, Japan
Akershus universitetssykehus /ID# 154279
Nordlenangen, Akershus, Norway
Drammen Sykehus /ID# 154280
Drammen, Buskerud, Norway
Haukeland University Hospital /ID# 154281
Bergen, Hordaland, Norway
Sykehuset Ostfold Kalnes /ID# 157755
Grålum, Norway
Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym im. Ludwika Rydygiera w /ID# 169846
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153389
Wroclaw, Lower Silesian Voivodeship, Poland
SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 153385
Chorzów, Silesian Voivodeship, Poland
Duplicate_Hospital de Braga /ID# 154797
Braga, Portugal
IPO Porto FG, EPE /ID# 154138
Porto, Portugal
VA Caribbean Healthcare System /ID# 160507
San Juan, Puerto Rico
Kuzbass Regional Clinical Hospital /ID# 157461
Kemerovo, Kemerovo Oblast, Russia
Moscow State budget healthcare /ID# 155738
Moscow, Moscow, Russia
Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 153268
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Duplicate_Regional Oncology Dispensary /ID# 153264
Penza, Penza Oblast, Russia
State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 157460
Ryazan, Ryazan Oblast, Russia
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 153267
Saratov, Saratov Oblast, Russia
Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 155740
Moscow, Russia
Samara State Medical University /ID# 157462
Samara, Russia
University of Pretoria /ID# 153682
Pretoria, Gauteng, South Africa
Albert Alberts Stem Cell Transplant Centre /ID# 153684
Pretoria, Gauteng, South Africa
Duplicate_Konkuk University Medical Ctr /ID# 153973
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital /ID# 153675
Seoul, South Korea
Samsung Medical Center /ID# 153674
Seoul, South Korea
Hospital Universitario de Navarra /ID# 153254
Pamplona, Navarre, Spain
Hospital Clinic de Barcelona /ID# 153255
Barcelona, Spain
Hospital Santa Creu i Sant Pau /ID# 153193
Barcelona, Spain
Hospital Universitario de la Princesa /ID# 153256
Madrid, Spain
Hospital General Universitario Gregorio Maranon /ID# 153260
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 153258
Madrid, Spain
Hospital Universitario Virgen de la Victoria /ID# 153257
Málaga, Spain
Hospital Universitario y Politecnico La Fe /ID# 153259
Valencia, Spain
Akademiska Sjukhuset /ID# 153034
Uppsala, Uppsala County, Sweden
Uddevalla sjukhus /ID# 156875
Uddevalla, Västra Götaland County, Sweden
Dup_VO Hematologi /ID# 153174
Lund, Sweden
Karolinska University Hospital /ID# 170003
Stockholm, Sweden
Changhua Christian Hospital /ID# 153899
Changhua, Changhua County, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 153902
Kaohsiung City, Taiwan
China Medical University Hospital /ID# 153904
Taichung, Taiwan
National Taiwan University Hospital /ID# 153900
Taipei, Taiwan
Hacettepe University Faculty of Medicine /ID# 202073
Ankara, Turkey (Türkiye)
Ankara Universitesi Fakultesi /ID# 155200
Ankara, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip /ID# 155201
Samsun, Turkey (Türkiye)
Kyiv city clinical hospital #9 /ID# 153510
Kiev, Vinnytsia Oblast, Ukraine
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 153511
Dnipro, Ukraine
Kyiv Regional Onco Dispensary /ID# 153514
Kyiv, Ukraine
Poltava Reg Clin Hosp Sklifoso /ID# 153513
Poltava, Ukraine