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 (Verona)

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myelodysplastic Syndrome (MDS)
• Intervention / Treatment: Drug: Venetoclax; Drug: Azacitidine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 531
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Duplicate_Blacktown Hospital /ID# 234079
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital /ID# 221810
    • Port Macquarie, New South Wales, Australia, 2444
      • Port Macquarie Base Hospital /ID# 234078
  • Queensland
    • Southport, Queensland, Australia, 4215
      • Gold coast University Hospital /ID# 222606
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 221805
  • Victoria
    • Fitzroy Melbourne, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne /ID# 221809
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health /ID# 221807
• Austria
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221092
  • Vienna, Austria, 1140
    • Hanusch Krankenhaus /ID# 221093
  • State of Vienna
    • Vienna, State of Vienna, Austria, 1090
      • Medizinische Universitaet Wien /ID# 221446
  • Upper Austria
    • Linz, Upper Austria, Austria, 4010
      • Ordensklinikum Linz GmbH Elisabethinen /ID# 221387
    • Wels, Upper Austria, Austria, 4600
      • Klinikum Wels-Grieskirchen GmbH /ID# 221386
• Belgium
  • Antwerpen
    • Antwerp, Antwerpen, Belgium, 2020
      • ZAS Middelheim /ID# 218907
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1200
      • Cliniques Universitaires UCL Saint-Luc /ID# 219066
  • Hainaut
    • La Louvière, Hainaut, Belgium, 7100
      • Hospital La Louviere Site Jolimont - Helora /ID# 218921
  • Namur
    • Yvoir, Namur, Belgium, 5530
      • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 219064
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent /ID# 218767
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Universitair Ziekenhuis Leuven /ID# 218905
  • West-Vlaanderen
    • Bruges, West-Vlaanderen, Belgium, 8000
      • AZ Sint-Jan Brugge /ID# 218212
• Brazil
  • Rio de Janeiro, Brazil, 20551-030
    • Hospital Universitário Pedro Ernesto /ID# 223080
  • São Paulo, Brazil, 05403-000
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 221339
  • Ceará
    • Fortaleza, Ceará, Brazil, 60430-372
      • Hospital Universitario Walter Cantidio /ID# 223434
  • Puerto Rico
    • Curitiba, Puerto Rico, Brazil, 81520-060
      • Hospital Erasto Gaertner /ID# 221341
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05652-900
      • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 221370
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • BC Cancer - Surrey /ID# 219098
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute /ID# 219105
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre /ID# 219103
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre - Glen Site /ID# 222519
    • Québec, Quebec, Canada, G1J 1Z4
      • CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 102206
      • Peking University International Hospital /ID# 222987
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Lanzhou University Second Hospital /ID# 225980
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital /ID# 221442
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital of Southern Medical University /ID# 222071
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University /ID# 224566
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University /ID# 222919
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital /ID# 221447
    • Zhengzhou, Henan, China, 450003
      • People's Hospital of Henan Province /ID# 225790
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Tongji Medical College of HUST /ID# 221474
    • Wuhan, Hubei, China, 430022
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 221475
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University /ID# 221849
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital /ID# 221342
    • Suzhou, Jiangsu, China, 215031
      • The First Affiliated Hospital of Soochow University /ID# 221640
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University /ID# 225983
  • Liaoning
    • Shenyang, Liaoning, China, 110022
      • Shengjing Hospital of China Medical University /ID# 222945
  • Shaanxi
    • Xi'an, Shaanxi, China, 710054
      • Shaanxi Provincial People'S Hospital /ID# 225728
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200233
      • Shanghai Sixth People's Hospital /ID# 221546
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University /ID# 221601
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital /ID# 226810
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310020
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 225982
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 221494
    • Yiwu, Zhejiang, China, 322000
      • The Fourth Affiliated Hospital Zhejiang University School of Medicine /ID# 225918
• Czechia
  • Prague, Czechia, 128 00
    • Ustav hematologie a krevni transfuze /ID# 221350
  • Brno-mesto
    • Brno, Brno-mesto, Czechia, 625 00
      • Fakultní Nemocnice Brno - Jihlavská /ID# 221351
  • Hradec Kralove
    • Hradec Králové, Hradec Kralove, Czechia, 500 05
      • Fakultní nemocnice Hradec Králové - Sokolská /ID# 221163
  • Ostrava-mesto
    • Ostrava, Ostrava-mesto, Czechia, 708 52
      • Fakultni Nemocnice Ostrava /ID# 219143
  • Plzen-jih
    • Pilsen, Plzen-jih, Czechia, 323 00
      • Fakultní Nemocnice Plzeň-Lochotín /ID# 221162
  • Praha 17
    • Prague, Praha 17, Czechia, 128 00
      • Všeobecná Fakultní Nemocnice v Praze /ID# 221229
• France
  • Paris, France, 75010
    • Hôpital Saint-Louis /ID# 222075
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • Chu de Nice-Hopital L'Archet Ii /Id# 220992
  • Gironde
    • Pessac, Gironde, France, 33604
      • Centre Hospitalier Universitaire de Bordeaux /ID# 220989
  • Isere
    • La Tronche, Isere, France, 38700
      • CHU Grenoble - Hopital Michallon /ID# 220988
  • Nord
    • Lille, Nord, France, 59037
      • CHRU Lille - Hopital Claude Huriez /ID# 220991
  • Pays de la Loire Region
    • Nantes, Pays de la Loire Region, France, 44000
      • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 222074
  • Provence-Alpes-Côte d'Azur Region
    • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
      • Hopital de la Conception /ID# 224882
  • Seine-Maritime
    • Rouen, Seine-Maritime, France, 76038
      • Centre Henri Becquerel /ID# 220986
  • Vaucluse
    • Avignon, Vaucluse, France, 84902
      • CH Henri Duffaut /ID# 225185
• Germany
  • Berlin, Germany, 12203
    • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189
  • Baden-Wurttemberg
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • Universitatsklinikum Mannheim /ID# 221172
    • Mutlangen, Baden-Wurttemberg, Germany, 73557
      • Stauferklinikum Schwaebisch Gmuend /ID# 224917
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Klinikum rechts der Isar /ID# 221170
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Medizinische Hochschule Hannover /ID# 221173
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Universitaetsklinikum Koeln /ID# 234219
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • Universitaetsklinikum Duesseldorf /ID# 221169
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Universitaetsklinikum Leipzig /ID# 221168
• Hungary
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem /ID# 221705
  • Fejér
    • Székesfehérvár, Fejér, Hungary, 8000
      • Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 222953
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 221702
  • Somogy County
    • Kaposvár, Somogy County, Hungary, 7400
      • Duplicate_Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 221703
  • Szabolcs-Szatmár-Bereg
    • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
      • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 221704
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 221083
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center /ID# 221184
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 91031
      • Shaare Zedek Medical Center /ID# 233181
    • Jerusalem, Jerusalem, Israel, 91120
      • Hadassah Medical Center-Hebrew University /ID# 222006
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 221110
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 221896
• Italy
  • Bologna, Italy, 40138
    • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 220810
  • Reggio Calabria, Italy, 89125
    • Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 220818
  • Lombardy
    • Rozzano, Lombardy, Italy, 20089
      • IRCCS Istituto Clinico Humanitas /ID# 220815
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816
  • Roma
    • Rome, Roma, Italy, 00189
      • Duplicate_Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819
• Japan
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital /ID# 222241
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 466-8560
      • Nagoya University Hospital /ID# 221566
  • Fukui
    • Yoshida-gun, Fukui, Japan, 910-1104
      • University of Fukui Hospital /ID# 221568
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital /ID# 223473
  • Fukushima
    • Fukushima, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital /ID# 222015
  • Hiroshima
    • Fukuyama, Hiroshima, Japan, 720-0001
      • Chugoku Central Hospital /ID# 222955
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 064-0804
      • Aiiku Hospital /ID# 222351
    • Sapporo, Hokkaido, Japan, 003-0006
      • Sapporo Hokuyu Hospital /ID# 222133
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0047
      • Kobe City Medical Center General Hospital /ID# 221977
  • Ibaraki
    • Higashiibaraki-gun, Ibaraki, Japan, 311-3193
      • NHO Mito Medical Center /ID# 222278
  • Miyagi
    • Sendai, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 221976
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 701-1192
      • Okayama Medical Center /ID# 222310
  • Osaka
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • Kindai University Hospital /ID# 222284
  • Saitama
    • Kawagoe, Saitama, Japan, 350-8550
      • Saitama Medical Center /ID# 222016
  • Tokyo
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • NTT Medical Center Tokyo /ID# 222365
  • Yamagata
    • Yamagata, Yamagata, Japan, 990-9585
      • Yamagata University Hospital /ID# 221574
• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht Universitair Medisch Centrum /ID# 221630
  • North Brabant
    • Eindhoven, North Brabant, Netherlands, 5631 BM
      • Maxima Medisch Centrum /ID# 223010
  • Overijssel
    • Enschede, Overijssel, Netherlands, 7512 KZ
      • Medisch Spectrum Twente /ID# 223012
    • Zwolle, Overijssel, Netherlands, 8025 AB
      • Isala /ID# 223011
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 CE
      • Erasmus Medisch Centrum /ID# 218937
• Poland
  • Katowice, Poland, 40-519
    • Pratia Onkologia Katowice /ID# 224728
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
      • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-081
      • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 221667
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 01-748
      • Lux Med Onkologia - Szpital Szamocka /Id# 222203
    • Warsaw, Masovian Voivodeship, Poland, 02-172
      • MTZ Clinical Research Powered by Pratia /ID# 221354
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-214
      • Uniwersyteckie Centrum Kliniczne /ID# 222069
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 93-513
      • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221784
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials, LLC /ID# 221010
  • San Juan, Puerto Rico, 00921-3201
    • VA Caribbean Healthcare System /ID# 221012
• Russia
  • Moscow, Russia, 127644
    • Hospital n.a. V.V. Veresaev /ID# 225435
  • Moscow, Russia, 129301
    • MMCC Kommunarka /ID# 221213
  • Saint Petersburg, Russia, 197341
    • Almazov National Medical Research Centre /ID# 221449
  • Kaluga Oblast
    • Kaluga, Kaluga Oblast, Russia, 248007
      • Kaluga Regional Clinical Hospital /ID# 221211
  • Murmansk Oblast
    • Petrozavodsk, Murmansk Oblast, Russia, 185019
      • Republican hospital named after V.A. Baranov /ID# 221214
  • Stavropol Kray
    • Pyatigorsk, Stavropol Kray, Russia, 357502
      • Clinic UZI 4D /ID# 221215
• South Korea
  • Seoul, South Korea, 03722
    • Yonsei University Health System Severance Hospital /ID# 233171
  • Busan Gwang Yeogsi
    • Busan, Busan Gwang Yeogsi, South Korea, 49241
      • Duplicate_Pusan National University Hospital /ID# 232353
  • Gyeonggido
    • Seongnam-si, Gyeonggido, South Korea, 13620
      • Seoul National University Bundang Hospital /ID# 221695
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital /ID# 221226
    • Seoul, Seoul Teugbyeolsi, South Korea, 05505
      • Asan Medical Center /ID# 221227
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center /ID# 221224
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron /ID# 221323
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 221271
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre /ID# 221272
  • Salamanca, Spain, 37711
    • Hospital Universitario de Salamanca /ID# 221297
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 221276
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 221270
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 221274
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia /ID# 221273
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Universitario Quironsalud Madrid /ID# 221275
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 218987
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital /ID# 218989
  • Tainan, Taiwan, 71004
    • Chi-Mei Medical Center /ID# 218991
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 833
      • Duplicate_Kaohsiung Chang Gung Memorial Hospital /ID# 223573
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Hacettepe University Faculty of Medicine /ID# 222094
  • Ankara, Turkey (Türkiye), 06800
    • Ankara City Hospital /ID# 222093
  • Antalya, Turkey (Türkiye), 07059
    • Akdeniz Universitesi Tip Fakul /ID# 222095
  • Samsun, Turkey (Türkiye), 55200
    • Ondokuz mayis University Facul /ID# 222091
  • Tuzla, Turkey (Türkiye), 34953
    • Acibadem Maslak Hastanesi /ID# 222072
  • Kayseri
    • Melikgazi, Kayseri, Turkey (Türkiye), 38030
      • Duplicate_Erciyes University Medical Fac /ID# 222090
• United Kingdom
  • Aberdeen, United Kingdom, AB15 6RE
    • NHS Grampian /ID# 222509
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust /ID# 221233
  • Bristol, United Kingdom, BS1 3NU
    • University Hospitals Bristol /ID# 222510
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust /ID# 221232
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
      • Derriford Hospital and the Royal Eye Infirmary /ID# 222514
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 2JB
      • University Hospitals Dorset NHS Foundation Trust /ID# 221237
  • Greater London
    • London, Greater London, United Kingdom, NW1 2BU
      • University College London Hospital /ID# 221240
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Oxford University Hospitals NHS Foundation Trust /ID# 221231
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4XN
      • Cardiff & Vale University Health Board /ID# 221236
• United States
  • California
    • Fullerton, California, United States, 92835
      • Duplicate_Providence Medical Foundation /ID# 222633
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles /ID# 221760
    • Torrance, California, United States, 90505-5004
      • Torrance Memorial Physician Network Cancer Care /ID# 222702
    • Whittier, California, United States, 90602-1006
      • PIH Health Whittier Hospital /ID# 222647
  • Colorado
    • Boulder, Colorado, United States, 80303
      • Rocky Mountain Cancer Centers - Boulder /ID# 223723
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine /ID# 222764
  • Delaware
    • Newark, Delaware, United States, 19713-2055
      • Helen F. Graham Cancer Center & Research Institute /ID# 223731
  • Florida
    • Fort Myers, Florida, United States, 33916
      • Florida Cancer Specialists - Fort Myers /ID# 221319
    • Hollywood, Florida, United States, 33021-3513
      • Memorial Healthcare System /ID# 222703
    • St. Petersburg, Florida, United States, 33705-1449
      • Florida Cancer Specialists - North /ID# 221318
    • Tallahassee, Florida, United States, 32308-5304
      • Florida Cancer Specialists - Panhandle /ID# 221315
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists - East /ID# 221317
  • Idaho
    • Boise, Idaho, United States, 83712-6267
      • St. Luke's Mountain State Tumor Institute /ID# 220838
  • Illinois
    • Chicago, Illinois, United States, 60611-2927
      • Northwestern University Feinberg School of Medicine /ID# 220843
    • Chicago, Illinois, United States, 60612
      • Duplicate_Rush University Medical Center /ID# 221007
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hosp /ID# 220844
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care, PC /ID# 220840
  • Indiana
    • Fort Wayne, Indiana, United States, 46845-1739
      • Duplicate_Parkview Cancer Institute /ID# 223620
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas /ID# 222648
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Hematology/Oncology Clinic /ID# 224257
    • Covington, Louisiana, United States, 70433-7512
      • Pontchartrain Cancer Center - Covington /ID# 221005
  • Maryland
    • Columbia, Maryland, United States, 21044-3128
      • Maryland Oncology Hematology /ID# 223776
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /ID# 225068
    • Boston, Massachusetts, United States, 02215-5400
      • Beth Israel Deaconess Medical Center /ID# 225069
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute /ID# 219162
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Ann Arbor Healthcare System /ID# 221365
    • Grand Rapids, Michigan, United States, 49503
      • Cancer & Hematology Centers /ID# 220848
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 221321
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • MidAmerica Division, Inc. /ID# 221895
  • Nevada
    • Henderson, Nevada, United States, 89052-2648
      • Comprehensive Cancer Centers of Nevada - Horizon Ridge /ID# 222635
  • New Jersey
    • East Brunswick, New Jersey, United States, 08816
      • Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 221003
    • Paramus, New Jersey, United States, 07652
      • The Valley Hospital /ID# 232337
  • New York
    • Albany, New York, United States, 12206-5013
      • New York Oncology Hematology - Albany Cancer Center /ID# 223778
    • Buffalo, New York, United States, 14222
      • University at Buffalo /ID# 221206
    • New York, New York, United States, 10065
      • Weill Cornell Medical College /ID# 222898
    • Stony Brook, New York, United States, 11794-8183
      • Stony Brook University Hospital /ID# 224450
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Presbyterian Medical Center /ID# 222561
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health Forsyth Medical Center /ID# 221004
  • Ohio
    • Cincinnati, Ohio, United States, 45236-2725
      • Oncology Hematology Care, Inc. /ID# 223724
  • Oregon
    • Bend, Oregon, United States, 97701
      • Bend Memorial Clinic /ID# 220999
    • Eugene, Oregon, United States, 97401-6043
      • Willamette Valley Cancer Institute and Research Center /ID# 223733
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Ctr /ID# 223201
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute /ID# 243461
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404-3230
      • Tennessee Oncology - Chattanooga / McCallie /ID# 221311
    • Nashville, Tennessee, United States, 37203-1632
      • Tennessee Oncology-Nashville Centennial /ID# 220854
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Oncology - Austin Midtown /ID# 223729
    • Dallas, Texas, United States, 75246-2003
      • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727
    • Dallas, Texas, United States, 75230
      • Duplicate_Texas Oncology - Medical City Dallas /ID# 223725
    • Fort Worth, Texas, United States, 76104-2150
      • Texas Oncology - Forth Worth /ID# 223777
    • Houston, Texas, United States, 77030-4000
      • MD Anderson Cancer Center at Texas Medical Center /ID# 219163
    • San Antonio, Texas, United States, 78240
      • Texas Oncology - San Antonio Medical Center - Research Drive /ID# 223728
    • Temple, Texas, United States, 76508-0001
      • Baylor Scott & White Medical Center- Temple /ID# 221332
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Northeast Texas /ID# 223734
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists Salt Lake Clinic /ID# 219160
  • Virginia
    • Gainesville, Virginia, United States, 20155-3257
      • Virginia Cancer Specialists - Gainesville /ID# 223726
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Medical Center Main Hospital /ID# 221590
    • Richmond, Virginia, United States, 23230
      • Virginia Cancer Institute at Reynolds Crossing /ID# 221002
  • Washington
    • Seattle, Washington, United States, 98108-1597
      • VA Puget Sound Health Care System /ID# 221358

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016 World Health Organization (WHO) classification wtih presence of < 20% bone marrow blasts per marrow biopsy/aspirate at screening.

• Participants must meet the following disease activity criteria:

  • Overall Revised International Prognostic Scoring System (IPSS-R) score > 3 (intermediate, high or very high).
  • Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.
  • Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of Study Day 1.

Exclusion Criteria:

• Prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogenic stem cell transplantation.
• Prior diagnosis of therapy-related MDS (t-MDS), MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Venetoclax + Azacitidine (AZA); Participants will receive venetoclax once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.	Drug: Venetoclax; Tablet: Oral; Other Names: Venclexta; ABT-199; GDC-0199; Drug: Azacitidine; Subcutaneous (SC) or Intravenous (IV) injection; Other Names: AZA
Active Comparator: Arm 2: Placebo + Azacitidine; Participants will receive placebo once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.	Drug: Azacitidine; Subcutaneous (SC) or Intravenous (IV) injection; Other Names: AZA; Drug: Placebo; Tablet; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS is defined as the number of days from the date of randomization to the date of death of any cause, or last known date to be alive.	Up To 5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Remission (CR)	CR is defined as achieving a complete remission at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).	Up To 36 Months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form (SF) 7a Scale Score	Fatigue will be assessed using the PROMIS Fatigue SF 7a Global Fatigue Score. PROMIS Fatigue SF 7a is a 7-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. Participants rate items on a 5-point scale, with 1 as "never" an 5 as "always".	Up To 5 Years
Time to Deterioration in Physical Functioning as Measured by Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scale	Time to deterioration in physical functioning, as measured by the EORTC QLQ-C30 physical functioning score is defined as the time from the date of randomization to the date of death of any cause, or the first time worsening of score from baseline >= a pre-specified threshold. Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."	Up To 5 Years
Overall Response (OR)	OR [complete remission (CR) + partial response (PR)] is defined as achieving a CR or PR at any time point during the study per the modified IWG 2006 criteria for MDS.	Up To 5 Years
Modified Overall Response (mOR)	mOR [complete remission (CR) + marrow complete remission (mCR) + partial response (PR)] is defined as achieving a CR, mCR, or PR at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).	Up To 5 Years
Percentage of Participants Achieving Overall Hematological Improvement (HI)	Overall HI is defined as achieving the response of HI-platelet or HI-neutrophil, or HI-erythroid at any time point during the study prior to post-treatment therapy per the modified IWG 2006 criteria for MDS.	Up to 5 Years
Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline	TI is when the participants who were transfusion dependent on red blood cell (RBC) and/or Platelet at baseline achieve transfusion independence post baseline. TI is a period of at least 56 days with no transfusion after the date of the first dose of study drug to the last dose of study drug + 30 days, or 1 day before the date of progressive disease/ relapse from CR or PR per the modified IWG 2006 criteria for MDS, or 1 day before the initiation of post-treatment therapy or 1 day before death, whichever is earliest.	Up To 5 Years

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: Genentech, Inc.
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• Stahl M, DeZern AE. Is there a path forward for immunotherapy in patients with myelodysplastic syndromes? Lancet Haematol. 2024 Jan;11(1):e5-e7. doi: 10.1016/S2352-3026(23)00343-5. Epub 2023 Dec 5. No abstract available.

Helpful Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: MDS; Venetoclax; Azacitidine; Venclexta; Myelodysplastic Syndrome; AZA
• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Aza Compounds; Nucleosides; Ribonucleosides; Azacitidine; venetoclax
• Other Study ID Numbers: M15-954; 2023-507153-16-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes