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)

March 12, 2024 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

Active, not recruiting

Conditions

Myelodysplastic Syndrome (MDS)

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

531

Phase

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
    - 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-Universitätsklinikum der PMU (LKH) /ID# 221092
  - Wien, Austria, 1140
    - Hanusch Krankenhaus /ID# 221093
- Oberoesterreich
  - Linz, Oberoesterreich, Austria, 4010
    - Ordensklinikum Linz GmbH Elisabethinen /ID# 221387
  - Wels, Oberoesterreich, Austria, 4600
    - Klinikum Wels-Grieskirchen GmbH /ID# 221386
- Wien
  - Vienna, Wien, Austria, 1090
    - Medizinische Universitaet Wien /ID# 221446
Belgium
- - Antwerp, Belgium, 2020
    - ZNA Middelheim /ID# 218907
  - Bruges, Belgium, 8000
    - Algemeen Ziekenhuis Sint-Jan /ID# 218212
- Bruxelles-Capitale
  - Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
    - UCL Saint-Luc /ID# 219066
- Hainaut
  - La Louvière, Hainaut, Belgium, 7100
    - Hospital La Louviere Site Jolimont - Helora /ID# 218921
- Namur
  - Godinne, Namur, Belgium, 5530
    - CHU UCL Namur - site Godinne /ID# 219064
- Oost-Vlaanderen
  - Gent, Oost-Vlaanderen, Belgium, 9000
    - UZ Gent /ID# 218767
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - Universitair Ziekenhuis Leuven /ID# 218905
Brazil
- - Rio de Janeiro, Brazil, 20551-030
    - Hospital Universitário Pedro Ernesto /ID# 223080
- Ceara
  - Fortaleza, Ceara, Brazil, 60430-372
    - Hospital Universitario Walter Cantidio /ID# 223434
- Sao Paulo
  - São Paulo, Sao Paulo, Brazil, 05652-900
    - Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 221370
  - São Paulo, Sao Paulo, Brazil, 05403-000
    - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 221339
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 Ctr /ID# 219103
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Center Research Institute /ID# 222519
  - Montreal, Quebec, Canada, H4J 1C5
    - CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973
  - Quebec City, Quebec, Canada, G1J 1Z4
    - CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200
China
- - Beijing, China, 102206
    - Peking University International Hospital /ID# 222987
  - Tianjin, China, 300052
    - Tianjin Medical University General Hospital /ID# 226810
- 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, 710000
    - Shaanxi Provincial people's Hospital /ID# 225728
- Shanghai
  - Shanghai, Shanghai, China, 200233
    - Shanghai Sixth People's Hospital /ID# 221546
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - West China Hospital, Sichuan University /ID# 221601
- Tianjin
  - Tianjin, Tianjin, China, 300020
    - Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567
- 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
- - Brno, Czechia, 613 00
    - Fakultni nemocnice Brno /ID# 221351
  - Hradec Kralove, Czechia, 500 05
    - Fakultni nemocnice Hradec Kralove /ID# 221163
  - Ostrava, Czechia, 708 52
    - Fakultni Nemocnice Ostrava /ID# 219143
  - Plzen, Czechia, 305 99
    - Fakultni nemocnice Plzen /ID# 221162
  - Praha, Czechia, 128 00
    - Ustav hematologie a krevni transfuze /ID# 221350
  - Praha, Czechia, 128 08
    - Vseobecna fakultni nemocnice v Praze /ID# 221229
France
- - La Tronche, France, 38700
    - CHU Grenoble - Hopital Michallon /ID# 220988
  - Marseille, France, 13005
    - AP-HM - Hopital de la Conception /ID# 224882
  - Paris, France, 75010
    - AP-HP - Hopital Saint-Louis /ID# 222075
  - Rouen, France, 76038
    - Centre Henri Becquerel /ID# 220986
- Alpes-Maritimes
  - Nice, Alpes-Maritimes, France, 06200
    - CHU de Nice - Hôpital Archet 1 /ID# 220992
- Gironde
  - Pessac, Gironde, France, 33604
    - CHU Bordeaux - Hopital Haut Leveque /ID# 220989
- Nord
  - Lille, Nord, France, 59037
    - CHRU Lille - Hopital Claude Huriez /ID# 220991
- Pays-de-la-Loire
  - Nantes, Pays-de-la-Loire, France, 44000
    - CHU de Nantes, Hotel Dieu -HME /ID# 222074
- Vaucluse
  - Avignon CEDEX 9, Vaucluse, France, 84902
    - CH Henri Duffaut /ID# 225185
Germany
- - Berlin, Germany, 12203
    - Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189
  - Hannover, Germany, 30625
    - Medizinische Hochschule Hannover /ID# 221173
  - Munich, Germany, 81675
    - Klinikum rechts der Isar /ID# 221170
- Baden-Wuerttemberg
  - Mannheim, Baden-Wuerttemberg, Germany, 68167
    - Universitatsklinikum Mannheim /ID# 221172
  - Mutlangen, Baden-Wuerttemberg, Germany, 73557
    - Stauferklinikum Schwaebisch Gmuend /ID# 224917
- Nordrhein-Westfalen
  - Düsseldorf, Nordrhein-Westfalen, Germany, 40225
    - Universitaetsklinikum Duesseldorf /ID# 221169
  - Köln, Nordrhein-Westfalen, Germany, 50937
    - Universitaetsklinikum Koeln /ID# 234219
- Sachsen
  - Leipzig, Sachsen, Germany, 04103
    - Universitaetsklinikum Leipzig /ID# 221168
Hungary
- Csongrad
  - Szeged, Csongrad, Hungary, 6725
    - Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221705
- Fejer
  - Szekesfehervar, Fejer, Hungary, 8000
    - Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 222953
- Hajdu-Bihar
  - Debrecen, Hajdu-Bihar, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont /ID# 221702
- Somogy
  - Kaposvár, Somogy, Hungary, 7400
    - Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 221703
- Szabolcs-Szatmar-Bereg
  - Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
    - Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 221704
Israel
- H_efa
  - Haifa, H_efa, Israel, 3109601
    - Rambam Health Care Campus /ID# 221083
  - Haifa, H_efa, Israel, 4941492
    - Rabin Medical Center /ID# 221184
- 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
- Yerushalayim
  - Jerusalem, Yerushalayim, Israel, 91120
    - Hadassah Medical Center-Hebrew University /ID# 222006
  - Jerusalem, Yerushalayim, Israel, 91031
    - Shaare Zedek Medical Center /ID# 233181
Italy
- - Bologna, Italy, 40138
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220810
  - Napoli, Italy, 80131
    - Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816
  - Reggio Calabria, Italy, 89124
    - Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 220818
  - Rome, Italy, 00189
    - Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819
- Milano
  - Rozzano, Milano, Italy, 20089
    - Istituto Clinico Humanitas /ID# 220815
Japan
- Aichi
  - Nagoya-shi, Aichi, Japan, 4668560
    - Nagoya University Hospital /ID# 221566
- Fukui
  - 吉田郡, Fukui, Japan, 910-1104
    - University of Fukui University Hospital /ID# 221568
- Fukuoka
  - Fukuoka-shi, Fukuoka, Japan, 812-8582
    - Kyushu University Hospital /ID# 223473
- Fukushima
  - Fukushima-shi, Fukushima, Japan, 960-1295
    - Fukushima Medical University Hospital /ID# 222015
- Hiroshima
  - Fukuyama-shi, Hiroshima, Japan, 720-0001
    - Chugoku Central Hospital /ID# 222955
- Hokkaido
  - Sapporo-shi, Hokkaido, Japan, 003-0006
    - Sapporo Hokuyu Hospital /ID# 222133
  - Sapporo-shi, Hokkaido, Japan, 064-0804
    - Aiiku Hospital /ID# 222351
- Hyogo
  - Kobe-shi, Hyogo, Japan, 650-0047
    - Kobe City Medical Center General Hospital /ID# 221977
- Ibaraki
  - Higashi Ibaraki-gun, Ibaraki, Japan, 311-3193
    - National Hospital Organization Mito Medical Center /ID# 222278
- Miyagi
  - Sendai-shi, Miyagi, Japan, 9808574
    - Tohoku University Hospital /ID# 221976
- Nagasaki
  - Nagasaki-shi, Nagasaki, Japan, 852-8501
    - Nagasaki University Hospital /ID# 222241
- Okayama
  - Okayama-shi, Okayama, Japan, 701-1192
    - Okayama Medical Center /ID# 222310
- Osaka
  - Osakasayama-shi, Osaka, Japan, 589-8511
    - Kindai University Hospital /ID# 222284
- Saitama
  - Kawagoe-shi, Saitama, Japan, 350-8550
    - Saitama Medical Center /ID# 222016
- Tokyo
  - Shinagawa-ku, Tokyo, Japan, 141-8625
    - NTT Medical Center Tokyo /ID# 222365
- Yamagata
  - Yamagata-shi, Yamagata, Japan, 990-9585
    - Yamagata University Hospital /ID# 221574
Korea, Republic of
- - Busan, Korea, Republic of, 49241
    - Pusan National University Hospital /ID# 232353
  - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital /ID# 221226
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center /ID# 221227
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center /ID# 221224
- Gyeonggido
  - Seongnam, Gyeonggido, Korea, Republic of, 13620
    - Seoul National University Bundang Hospital /ID# 221695
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
    - Yonsei University Health System Severance Hospital /ID# 233171
Netherlands
- - Eindhoven, Netherlands, 5631 BM
    - Maxima Medisch Centrum /ID# 223010
  - Enschede, Netherlands, 7512 KZ
    - Medisch Spectrum Twente /ID# 223012
  - Maastricht, Netherlands, 6229 HX
    - Maastricht Universitair Medisch Centrum /ID# 221630
  - Zwolle, Netherlands, 8025 AB
    - Isala /ID# 223011
- Zuid-Holland
  - Rotterdam, Zuid-Holland, Netherlands, 3015 GD
    - Erasmus Medisch Centrum /ID# 218937
Poland
- - Katowice, Poland, 40-519
    - Pratia Onkologia Katowice /ID# 224728
- Kujawsko-pomorskie
  - Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
    - Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321
- Lodzkie
  - Lodz, Lodzkie, Poland, 93-513
    - Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopern /Id# 221784
- Lubelskie
  - Lublin, Lubelskie, Poland, 20-081
    - Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 221667
- Mazowieckie
  - Warszawa, Mazowieckie, Poland, 01-748
    - Lux Med Onkologia - Szpital Szamocka /Id# 222203
  - Warszawa, Mazowieckie, Poland, 02-172
    - MTZ Clinical Research Powered by Pratia /ID# 221354
- Pomorskie
  - Gdansk, Pomorskie, Poland, 80-214
    - Uniwersyteckie Centrum Kliniczne /ID# 222069
Puerto Rico
- - Curitiba, Puerto Rico, 81520-060
    - Hospital Erasto Gaertner /ID# 221341
  - 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
Russian Federation
- - Moscow, Russian Federation, 127644
    - Hospital n.a. V.V. Veresaev /ID# 225435
  - Moscow, Russian Federation, 129301
    - MMCC Kommunarka /ID# 221213
  - Petrozavodsk, Russian Federation, 185019
    - Republican hospital named after V.A. Baranov /ID# 221214
  - Sankt-Peterburg, Russian Federation, 197341
    - Almazov National Medical Research Centre /ID# 221449
- Kaluzhskaya Oblast
  - Kaluga, Kaluzhskaya Oblast, Russian Federation, 248007
    - Kaluga Regional Clinical Hospital /ID# 221211
- Stavropol Skiy Kray
  - Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357502
    - Clinic UZI 4D /ID# 221215
Spain
- - Barcelona, Spain, 08035
    - Hospital Universitario Vall d'Hebron /ID# 221323
  - Cordoba, Spain, 14004
    - Hospital Universitario Reina Sofia /ID# 221273
  - 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
  - Sevilla, 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
- Madrid
  - Pozuelo de Alarcón, Madrid, Spain, 28223
    - Hospital Universitario Quirón Salud 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
    - Kaohsiung Chang Gung Memorial Hospital /ID# 223573
Turkey
- - Ankara, Turkey, 06100
    - Hacettepe University Faculty of Medicine /ID# 222094
  - Ankara, Turkey, 06800
    - Ankara City Hospital /ID# 222093
  - Antalya, Turkey, 07059
    - Akdeniz Universitesi Tip Fakul /ID# 222095
  - Samsun, Turkey, 55200
    - Ondokuz mayis University Facul /ID# 222091
  - Tuzla, Turkey, 34953
    - Acibadem Maslak Hastanesi /ID# 222072
- Kayseri
  - Melikgazi, Kayseri, Turkey, 38030
    - 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
  - London, United Kingdom, NW1 2PG
    - University College London Hospitals NHS Foundation Trust /ID# 221240
  - London, United Kingdom, SW3 6JJ
    - The Royal Marsden NHS Foundation Trust /ID# 221232
  - Plymouth, United Kingdom, PL6 5FP
    - University Hospital Plymouth NHS Trust /ID# 222514
- Bristol, City Of
  - Bristol, Bristol, City Of, United Kingdom, BS1 3NU
    - University Hospitals Bristol NHS Foundation Trust /ID# 222510
- Dorset
  - Poole, Dorset, United Kingdom, BH15 2JB
    - University Hospitals Dorset NHS Foundation Trust /ID# 221237
- 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 /ID# 223723
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Yale University /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
  - Saint 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
    - 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, 75230
    - Texas Oncology - Medical City Dallas /ID# 223725
  - Dallas, Texas, United States, 75246-2003
    - Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727
  - 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, 78240-5251
    - Texas Oncology - San Antonio Medical Center /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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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

Number of Arms

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) 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

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

AbbVie

Collaborators

Genentech, Inc.

Investigators

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.

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

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)

September 10, 2020

Primary Completion (Estimated)

February 14, 2025

Study Completion (Estimated)

September 10, 2025

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)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M15-954
2020-000744-55 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on 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

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.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Myelodysplastic Syndrome (MDS)

Clinical Trials on Venetoclax

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