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)

May 1, 2026 updated by: AbbVie

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
531

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up To 5 Years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Remission (CR)
Time Frame: Up To 36 Months
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
Time Frame: Up To 5 Years
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 Frame: Up To 5 Years
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)
Time Frame: Up To 5 Years
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)
Time Frame: Up To 5 Years
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)
Time Frame: Up to 5 Years
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
Time Frame: Up To 5 Years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myelodysplastic Syndrome (MDS)

Clinical Trials on Venetoclax

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings