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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
Sponsor: AbbVie
Summary
Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS. Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.
Official title: A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Azacitidine in Patients Newly Diagnosed With Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
531
Start Date
2020-09-10
Completion Date
2026-03
Last Updated
2025-08-05
Healthy Volunteers
No
Conditions
Interventions
Venetoclax
Tablet: Oral
Azacitidine
Subcutaneous (SC) or Intravenous (IV) injection
Placebo
Tablet; Oral
Locations (220)
Duplicate_Providence Medical Foundation /ID# 222633
Fullerton, California, United States
University of California, Los Angeles /ID# 221760
Los Angeles, California, United States
Torrance Memorial Physician Network Cancer Care /ID# 222702
Torrance, California, United States
PIH Health Whittier Hospital /ID# 222647
Whittier, California, United States
Rocky Mountain Cancer Centers - Boulder /ID# 223723
Boulder, Colorado, United States
Yale University School of Medicine /ID# 222764
New Haven, Connecticut, United States
Helen F. Graham Cancer Center & Research Institute /ID# 223731
Newark, Delaware, United States
Florida Cancer Specialists - Fort Myers /ID# 221319
Fort Myers, Florida, United States
Memorial Healthcare System /ID# 222703
Hollywood, Florida, United States
Florida Cancer Specialists - North /ID# 221318
St. Petersburg, Florida, United States
Florida Cancer Specialists - Panhandle /ID# 221315
Tallahassee, Florida, United States
Florida Cancer Specialists - East /ID# 221317
West Palm Beach, Florida, United States
St. Luke's Mountain State Tumor Institute /ID# 220838
Boise, Idaho, United States
Northwestern University Feinberg School of Medicine /ID# 220843
Chicago, Illinois, United States
Duplicate_Rush University Medical Center /ID# 221007
Chicago, Illinois, United States
Ingalls Memorial Hosp /ID# 220844
Harvey, Illinois, United States
Illinois Cancer Care, PC /ID# 220840
Peoria, Illinois, United States
Duplicate_Parkview Cancer Institute /ID# 223620
Fort Wayne, Indiana, United States
Cancer Center of Kansas /ID# 222648
Wichita, Kansas, United States
Hematology/Oncology Clinic /ID# 224257
Baton Rouge, Louisiana, United States
Pontchartrain Cancer Center - Covington /ID# 221005
Covington, Louisiana, United States
Maryland Oncology Hematology /ID# 223776
Columbia, Maryland, United States
Massachusetts General Hospital /ID# 225068
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 225069
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 219162
Boston, Massachusetts, United States
VA Ann Arbor Healthcare System /ID# 221365
Ann Arbor, Michigan, United States
Cancer & Hematology Centers /ID# 220848
Grand Rapids, Michigan, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 221321
Saint Louis Park, Minnesota, United States
MidAmerica Division, Inc. /ID# 221895
Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada - Horizon Ridge /ID# 222635
Henderson, Nevada, United States
Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 221003
East Brunswick, New Jersey, United States
The Valley Hospital /ID# 232337
Paramus, New Jersey, United States
New York Oncology Hematology - Albany Cancer Center /ID# 223778
Albany, New York, United States
University at Buffalo /ID# 221206
Buffalo, New York, United States
Weill Cornell Medical College /ID# 222898
New York, New York, United States
Stony Brook University Hospital /ID# 224450
Stony Brook, New York, United States
Novant Health Presbyterian Medical Center /ID# 222561
Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center /ID# 221004
Winston-Salem, North Carolina, United States
Oncology Hematology Care, Inc. /ID# 223724
Cincinnati, Ohio, United States
Bend Memorial Clinic /ID# 220999
Bend, Oregon, United States
Willamette Valley Cancer Institute and Research Center /ID# 223733
Eugene, Oregon, United States
UPMC Hillman Cancer Ctr /ID# 223201
Pittsburgh, Pennsylvania, United States
Avera Cancer Institute /ID# 243461
Sioux Falls, South Dakota, United States
Tennessee Oncology - Chattanooga / McCallie /ID# 221311
Chattanooga, Tennessee, United States
Tennessee Oncology-Nashville Centennial /ID# 220854
Nashville, Tennessee, United States
Texas Oncology - Austin Midtown /ID# 223729
Austin, Texas, United States
Duplicate_Texas Oncology - Medical City Dallas /ID# 223725
Dallas, Texas, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727
Dallas, Texas, United States
Texas Oncology - Forth Worth /ID# 223777
Fort Worth, Texas, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 219163
Houston, Texas, United States
Texas Oncology - San Antonio Medical Center - Research Drive /ID# 223728
San Antonio, Texas, United States
Baylor Scott & White Medical Center- Temple /ID# 221332
Temple, Texas, United States
Texas Oncology - Northeast Texas /ID# 223734
Tyler, Texas, United States
Utah Cancer Specialists Salt Lake Clinic /ID# 219160
Salt Lake City, Utah, United States
Virginia Cancer Specialists - Gainesville /ID# 223726
Gainesville, Virginia, United States
Virginia Commonwealth University Medical Center Main Hospital /ID# 221590
Richmond, Virginia, United States
Virginia Cancer Institute at Reynolds Crossing /ID# 221002
Richmond, Virginia, United States
VA Puget Sound Health Care System /ID# 221358
Seattle, Washington, United States
Duplicate_Blacktown Hospital /ID# 234079
Blacktown, New South Wales, Australia
St George Hospital /ID# 221810
Kogarah, New South Wales, Australia
Port Macquarie Base Hospital /ID# 234078
Port Macquarie, New South Wales, Australia
Gold coast University Hospital /ID# 222606
Southport, Queensland, Australia
Royal Adelaide Hospital /ID# 221805
Adelaide, South Australia, Australia
St Vincent's Hospital Melbourne /ID# 221809
Fitzroy Melbourne, Victoria, Australia
Austin Health /ID# 221807
Heidelberg, Victoria, Australia
Ordensklinikum Linz GmbH Elisabethinen /ID# 221387
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH /ID# 221386
Wels, Upper Austria, Austria
Medizinische Universitaet Wien /ID# 221446
Vienna, Vienna, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221092
Salzburg, Austria
Hanusch Krankenhaus /ID# 221093
Vienna, Austria
ZAS Middelheim /ID# 218907
Antwerp, Antwerpen, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 219066
Brussels, Brussels Capital, Belgium
Hospital La Louviere Site Jolimont - Helora /ID# 218921
La Louvière, Hainaut, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 219064
Yvoir, Namur, Belgium
UZ Gent /ID# 218767
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 218905
Leuven, Vlaams-Brabant, Belgium
AZ Sint-Jan Brugge /ID# 218212
Bruges, West-Vlaanderen, Belgium
Hospital Universitario Walter Cantidio /ID# 223434
Fortaleza, Ceará, Brazil
Hospital Erasto Gaertner /ID# 221341
Curitiba, Puerto Rico, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 221370
São Paulo, São Paulo, Brazil
Hospital Universitário Pedro Ernesto /ID# 223080
Rio de Janeiro, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 221339
São Paulo, Brazil
BC Cancer - Surrey /ID# 219098
Surrey, British Columbia, Canada
Ottawa Hospital Research Institute /ID# 219105
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre /ID# 219103
Toronto, Ontario, Canada
McGill University Health Centre - Glen Site /ID# 222519
Montreal, Quebec, Canada
CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973
Montreal, Quebec, Canada
CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200
Québec, Quebec, Canada
Peking University International Hospital /ID# 222987
Beijing, Beijing Municipality, China
Lanzhou University Second Hospital /ID# 225980
Lanzhou, Gansu, China
Guangdong Provincial People's Hospital /ID# 221442
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University /ID# 222071
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 224566
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University /ID# 222919
Shijiazhuang, Hebei, China
People's Hospital of Henan Province /ID# 225790
Zhengzhou, Henan, China
Henan Cancer Hospital /ID# 221447
Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 221475
Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of HUST /ID# 221474
Wuhan, Hubei, China
Zhongda Hospital Southeast University /ID# 221849
Nanjing, Jiangsu, China
Jiangsu Province Hospital /ID# 221342
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University /ID# 221640
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 225983
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University /ID# 222945
Shenyang, Liaoning, China
Shaanxi Provincial People'S Hospital /ID# 225728
Xi'an, Shaanxi, China
Shanghai Sixth People's Hospital /ID# 221546
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University /ID# 221601
Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital /ID# 226810
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 221494
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 225982
Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital Zhejiang University School of Medicine /ID# 225918
Yiwu, Zhejiang, China
Fakultní Nemocnice Brno - Jihlavská /ID# 221351
Brno, Brno-mesto, Czechia
Fakultní nemocnice Hradec Králové - Sokolská /ID# 221163
Hradec Králové, Hradec Kralove, Czechia
Fakultni Nemocnice Ostrava /ID# 219143
Ostrava, Ostrava-mesto, Czechia
Fakultní Nemocnice Plzeň-Lochotín /ID# 221162
Pilsen, Plzen-jih, Czechia
Všeobecná Fakultní Nemocnice v Praze /ID# 221229
Prague, Praha 17, Czechia
Ustav hematologie a krevni transfuze /ID# 221350
Prague, Czechia
Chu de Nice-Hopital L'Archet Ii /Id# 220992
Nice, Alpes-Maritimes, France
Centre Hospitalier Universitaire de Bordeaux /ID# 220989
Pessac, Gironde, France
CHU Grenoble - Hopital Michallon /ID# 220988
La Tronche, Isere, France
CHRU Lille - Hopital Claude Huriez /ID# 220991
Lille, Nord, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 222074
Nantes, Pays de la Loire Region, France
Hopital de la Conception /ID# 224882
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Henri Becquerel /ID# 220986
Rouen, Seine-Maritime, France
CH Henri Duffaut /ID# 225185
Avignon, Vaucluse, France
Hôpital Saint-Louis /ID# 222075
Paris, France
Universitatsklinikum Mannheim /ID# 221172
Mannheim, Baden-Wurttemberg, Germany
Stauferklinikum Schwaebisch Gmuend /ID# 224917
Mutlangen, Baden-Wurttemberg, Germany
Klinikum rechts der Isar /ID# 221170
Munich, Bavaria, Germany
Medizinische Hochschule Hannover /ID# 221173
Hanover, Lower Saxony, Germany
Universitaetsklinikum Koeln /ID# 234219
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Duesseldorf /ID# 221169
Düsseldorf, North Rhine-Westphalia, Germany
Universitaetsklinikum Leipzig /ID# 221168
Leipzig, Saxony, Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189
Berlin, Germany
Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 222953
Székesfehérvár, Fejér, Hungary
Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 221702
Debrecen, Hajdú-Bihar, Hungary
Duplicate_Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 221703
Kaposvár, Somogy County, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 221704
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Szegedi Tudományegyetem /ID# 221705
Szeged, Hungary
Shaare Zedek Medical Center /ID# 233181
Jerusalem, Jerusalem, Israel
Hadassah Medical Center-Hebrew University /ID# 222006
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 221110
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 221896
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 221083
Haifa, Israel
Rabin Medical Center /ID# 221184
Petah Tikva, Israel
IRCCS Istituto Clinico Humanitas /ID# 220815
Rozzano, Lombardy, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816
Naples, Napoli, Italy
Duplicate_Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819
Rome, Roma, Italy
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 220810
Bologna, Italy
Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 220818
Reggio Calabria, Italy
Nagoya University Hospital /ID# 221566
Nagoya, Aichi-ken, Japan
University of Fukui Hospital /ID# 221568
Yoshida-gun, Fukui, Japan
Kyushu University Hospital /ID# 223473
Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital /ID# 222015
Fukushima, Fukushima, Japan
Chugoku Central Hospital /ID# 222955
Fukuyama, Hiroshima, Japan
Sapporo Hokuyu Hospital /ID# 222133
Sapporo, Hokkaido, Japan
Aiiku Hospital /ID# 222351
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital /ID# 221977
Kobe, Hyōgo, Japan
NHO Mito Medical Center /ID# 222278
Higashiibaraki-gun, Ibaraki, Japan
Tohoku University Hospital /ID# 221976
Sendai, Miyagi, Japan
Okayama Medical Center /ID# 222310
Okayama, Okayama-ken, Japan
Kindai University Hospital /ID# 222284
Osakasayama-shi, Osaka, Japan
Saitama Medical Center /ID# 222016
Kawagoe, Saitama, Japan
NTT Medical Center Tokyo /ID# 222365
Shinagawa-ku, Tokyo, Japan
Yamagata University Hospital /ID# 221574
Yamagata, Yamagata, Japan
Nagasaki University Hospital /ID# 222241
Nagasaki, Japan
Maastricht Universitair Medisch Centrum /ID# 221630
Maastricht, Limburg, Netherlands
Maxima Medisch Centrum /ID# 223010
Eindhoven, North Brabant, Netherlands
Medisch Spectrum Twente /ID# 223012
Enschede, Overijssel, Netherlands
Isala /ID# 223011
Zwolle, Overijssel, Netherlands
Erasmus Medisch Centrum /ID# 218937
Rotterdam, South Holland, Netherlands
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 221667
Lublin, Lublin Voivodeship, Poland
Lux Med Onkologia - Szpital Szamocka /Id# 222203
Warsaw, Masovian Voivodeship, Poland
MTZ Clinical Research Powered by Pratia /ID# 221354
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne /ID# 222069
Gdansk, Pomeranian Voivodeship, Poland
Pratia Onkologia Katowice /ID# 224728
Katowice, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221784
Lodz, Łódź Voivodeship, Poland
Pan American Center for Oncology Trials, LLC /ID# 221010
Rio Piedras, Puerto Rico
VA Caribbean Healthcare System /ID# 221012
San Juan, Puerto Rico
Kaluga Regional Clinical Hospital /ID# 221211
Kaluga, Kaluga Oblast, Russia
Republican hospital named after V.A. Baranov /ID# 221214
Petrozavodsk, Murmansk Oblast, Russia
Clinic UZI 4D /ID# 221215
Pyatigorsk, Stavropol Kray, Russia
Hospital n.a. V.V. Veresaev /ID# 225435
Moscow, Russia
MMCC Kommunarka /ID# 221213
Moscow, Russia
Almazov National Medical Research Centre /ID# 221449
Saint Petersburg, Russia
Duplicate_Pusan National University Hospital /ID# 232353
Busan, Busan Gwang Yeogsi, South Korea
Seoul National University Bundang Hospital /ID# 221695
Seongnam-si, Gyeonggido, South Korea
Seoul National University Hospital /ID# 221226
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 221227
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 221224
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 233171
Seoul, South Korea
Hospital Universitario Germans Trias i Pujol /ID# 221274
Badalona, Barcelona, Spain
Hospital Universitario Reina Sofia /ID# 221273
Córdoba, Cordoba, Spain
Hospital Universitario Quironsalud Madrid /ID# 221275
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Vall d'Hebron /ID# 221323
Barcelona, Spain
Hospital General Universitario Gregorio Maranon /ID# 221271
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 221272
Madrid, Spain
Hospital Universitario de Salamanca /ID# 221297
Salamanca, Spain
Hospital Universitario Virgen del Rocio /ID# 221276
Seville, Spain
Hospital Universitario y Politecnico La Fe /ID# 221270
Valencia, Spain
Duplicate_Kaohsiung Chang Gung Memorial Hospital /ID# 223573
Kaohsiung City, Kaohsiung, Taiwan
China Medical University Hospital /ID# 218987
Taichung, Taiwan
National Cheng Kung University Hospital /ID# 218989
Tainan, Taiwan
Chi-Mei Medical Center /ID# 218991
Tainan, Taiwan
Duplicate_Erciyes University Medical Fac /ID# 222090
Melikgazi, Kayseri, Turkey (Türkiye)
Hacettepe University Faculty of Medicine /ID# 222094
Ankara, Turkey (Türkiye)
Ankara City Hospital /ID# 222093
Ankara, Turkey (Türkiye)
Akdeniz Universitesi Tip Fakul /ID# 222095
Antalya, Turkey (Türkiye)
Ondokuz mayis University Facul /ID# 222091
Samsun, Turkey (Türkiye)
Acibadem Maslak Hastanesi /ID# 222072
Tuzla, Turkey (Türkiye)
Derriford Hospital and the Royal Eye Infirmary /ID# 222514
Plymouth, Devon, United Kingdom
University Hospitals Dorset NHS Foundation Trust /ID# 221237
Poole, Dorset, United Kingdom
University College London Hospital /ID# 221240
London, Greater London, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 221231
Oxford, Oxfordshire, United Kingdom
Cardiff & Vale University Health Board /ID# 221236
Cardiff, Wales, United Kingdom
NHS Grampian /ID# 222509
Aberdeen, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 221233
Birmingham, United Kingdom
University Hospitals Bristol /ID# 222510
Bristol, United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 221232
London, United Kingdom