AzTrials
AzTrials

Myelodysplastic Syndrome (MDS)Phase 3VeronaNCT04401748

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

A Phase 3 study testing Venetoclax and Azacitidine in people with Myelodysplastic Syndrome (MDS), run by AbbVie at 220 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndrome (MDS)
What is being tested?
Venetoclax and Azacitidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
531 participants
Where
220 sitesin 23 countries
Study dates
10 Sep 2020to Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

220 sites in 23 countries.

220 sites in 23 countries

United States58 sites

  • New York Oncology Hematology - Albany Cancer Center /ID# 223778

    Albany, New York, 12206-5013

  • VA Ann Arbor Healthcare System /ID# 221365

    Ann Arbor, Michigan, 48105

  • Texas Oncology - Austin Midtown /ID# 223729

    Austin, Texas, 78705

  • Hematology/Oncology Clinic /ID# 224257

    Baton Rouge, Louisiana, 70809

  • Bend Memorial Clinic /ID# 220999

    Bend, Oregon, 97701

  • St. Luke's Mountain State Tumor Institute /ID# 220838

    Boise, Idaho, 83712-6267

  • Massachusetts General Hospital /ID# 225068

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center /ID# 225069

    Boston, Massachusetts, 02215-5400

  • Dana-Farber Cancer Institute /ID# 219162

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers - Boulder /ID# 223723

    Boulder, Colorado, 80303

  • University at Buffalo /ID# 221206

    Buffalo, New York, 14222

  • Novant Health Presbyterian Medical Center /ID# 222561

    Charlotte, North Carolina, 28204

  • Tennessee Oncology - Chattanooga / McCallie /ID# 221311

    Chattanooga, Tennessee, 37404-3230

  • Northwestern University Feinberg School of Medicine /ID# 220843

    Chicago, Illinois, 60611-2927

  • Duplicate_Rush University Medical Center /ID# 221007

    Chicago, Illinois, 60612

  • Oncology Hematology Care, Inc. /ID# 223724

    Cincinnati, Ohio, 45236-2725

  • Maryland Oncology Hematology /ID# 223776

    Columbia, Maryland, 21044-3128

  • Pontchartrain Cancer Center - Covington /ID# 221005

    Covington, Louisiana, 70433-7512

  • Duplicate_Texas Oncology - Medical City Dallas /ID# 223725

    Dallas, Texas, 75230

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727

    Dallas, Texas, 75246-2003

  • Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 221003

    East Brunswick, New Jersey, 08816

  • Willamette Valley Cancer Institute and Research Center /ID# 223733

    Eugene, Oregon, 97401-6043

  • Florida Cancer Specialists - Fort Myers /ID# 221319

    Fort Myers, Florida, 33916

  • Duplicate_Parkview Cancer Institute /ID# 223620

    Fort Wayne, Indiana, 46845-1739

  • Texas Oncology - Forth Worth /ID# 223777

    Fort Worth, Texas, 76104-2150

  • Duplicate_Providence Medical Foundation /ID# 222633

    Fullerton, California, 92835

  • Virginia Cancer Specialists - Gainesville /ID# 223726

    Gainesville, Virginia, 20155-3257

  • Cancer & Hematology Centers /ID# 220848

    Grand Rapids, Michigan, 49503

  • Ingalls Memorial Hosp /ID# 220844

    Harvey, Illinois, 60426

  • Comprehensive Cancer Centers of Nevada - Horizon Ridge /ID# 222635

    Henderson, Nevada, 89052-2648

  • Memorial Healthcare System /ID# 222703

    Hollywood, Florida, 33021-3513

  • MD Anderson Cancer Center at Texas Medical Center /ID# 219163

    Houston, Texas, 77030-4000

  • MidAmerica Division, Inc. /ID# 221895

    Kansas City, Missouri, 64132

  • University of California, Los Angeles /ID# 221760

    Los Angeles, California, 90095

  • Tennessee Oncology-Nashville Centennial /ID# 220854

    Nashville, Tennessee, 37203-1632

  • Yale University School of Medicine /ID# 222764

    New Haven, Connecticut, 06510

  • Weill Cornell Medical College /ID# 222898

    New York, New York, 10065

  • Helen F. Graham Cancer Center & Research Institute /ID# 223731

    Newark, Delaware, 19713-2055

  • The Valley Hospital /ID# 232337

    Paramus, New Jersey, 07652

  • Illinois Cancer Care, PC /ID# 220840

    Peoria, Illinois, 61615

  • UPMC Hillman Cancer Ctr /ID# 223201

    Pittsburgh, Pennsylvania, 15232

  • Virginia Commonwealth University Medical Center Main Hospital /ID# 221590

    Richmond, Virginia, 23219

  • Virginia Cancer Institute at Reynolds Crossing /ID# 221002

    Richmond, Virginia, 23230

  • Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 221321

    Saint Louis Park, Minnesota, 55416

  • Utah Cancer Specialists Salt Lake Clinic /ID# 219160

    Salt Lake City, Utah, 84106

  • Texas Oncology - San Antonio Medical Center - Research Drive /ID# 223728

    San Antonio, Texas, 78240

  • VA Puget Sound Health Care System /ID# 221358

    Seattle, Washington, 98108-1597

  • Avera Cancer Institute /ID# 243461

    Sioux Falls, South Dakota, 57105

  • Florida Cancer Specialists - North /ID# 221318

    St. Petersburg, Florida, 33705-1449

  • Stony Brook University Hospital /ID# 224450

    Stony Brook, New York, 11794-8183

  • Florida Cancer Specialists - Panhandle /ID# 221315

    Tallahassee, Florida, 32308-5304

  • Baylor Scott & White Medical Center- Temple /ID# 221332

    Temple, Texas, 76508-0001

  • Torrance Memorial Physician Network Cancer Care /ID# 222702

    Torrance, California, 90505-5004

  • Texas Oncology - Northeast Texas /ID# 223734

    Tyler, Texas, 75702

  • Florida Cancer Specialists - East /ID# 221317

    West Palm Beach, Florida, 33401

  • PIH Health Whittier Hospital /ID# 222647

    Whittier, California, 90602-1006

  • Cancer Center of Kansas /ID# 222648

    Wichita, Kansas, 67214

  • Novant Health Forsyth Medical Center /ID# 221004

    Winston-Salem, North Carolina, 27103

Other trials in United States

China23 sites

  • Peking University International Hospital /ID# 222987

    Beijing, Beijing Municipality, 102206

  • West China Hospital, Sichuan University /ID# 221601

    Chengdu, Sichuan, 610041

  • Guangdong Provincial People's Hospital /ID# 221442

    Guangzhou, Guangdong, 510080

  • Zhujiang Hospital of Southern Medical University /ID# 222071

    Guangzhou, Guangdong, 510280

  • Nanfang Hospital of Southern Medical University /ID# 224566

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 221494

    Hangzhou, Zhejiang, 310003

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 225982

    Hangzhou, Zhejiang, 310020

  • Lanzhou University Second Hospital /ID# 225980

    Lanzhou, Gansu, 730030

  • The First Affiliated Hospital of Nanchang University /ID# 225983

    Nanchang, Jiangxi, 330006

  • Zhongda Hospital Southeast University /ID# 221849

    Nanjing, Jiangsu, 210009

  • Jiangsu Province Hospital /ID# 221342

    Nanjing, Jiangsu, 210029

  • Shanghai Sixth People's Hospital /ID# 221546

    Shanghai, Shanghai Municipality, 200233

  • Shengjing Hospital of China Medical University /ID# 222945

    Shenyang, Liaoning, 110022

  • The Second Hospital of Hebei Medical University /ID# 222919

    Shijiazhuang, Hebei, 050000

  • The First Affiliated Hospital of Soochow University /ID# 221640

    Suzhou, Jiangsu, 215031

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University General Hospital /ID# 226810

    Tianjin, Tianjin Municipality, 300052

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 221475

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical College of HUST /ID# 221474

    Wuhan, Hubei, 430030

  • Shaanxi Provincial People'S Hospital /ID# 225728

    Xi'an, Shaanxi, 710054

  • The Fourth Affiliated Hospital Zhejiang University School of Medicine /ID# 225918

    Yiwu, Zhejiang, 322000

  • People's Hospital of Henan Province /ID# 225790

    Zhengzhou, Henan, 450003

  • Henan Cancer Hospital /ID# 221447

    Zhengzhou, Henan, 450008

Other trials in China

Japan16 sites

  • Kyushu University Hospital /ID# 223473

    Fukuoka, Fukuoka, 812-8582

  • Fukushima Medical University Hospital /ID# 222015

    Fukushima, Fukushima, 960-1295

  • Chugoku Central Hospital /ID# 222955

    Fukuyama, Hiroshima, 720-0001

  • NHO Mito Medical Center /ID# 222278

    Higashiibaraki-gun, Ibaraki, 311-3193

  • Saitama Medical Center /ID# 222016

    Kawagoe, Saitama, 350-8550

  • Kobe City Medical Center General Hospital /ID# 221977

    Kobe, Hyōgo, 650-0047

  • Nagasaki University Hospital /ID# 222241

    Nagasaki, 852-8501

  • Nagoya University Hospital /ID# 221566

    Nagoya, Aichi-ken, 466-8560

  • Okayama Medical Center /ID# 222310

    Okayama, Okayama-ken, 701-1192

  • Kindai University Hospital /ID# 222284

    Osakasayama-shi, Osaka, 589-8511

  • Sapporo Hokuyu Hospital /ID# 222133

    Sapporo, Hokkaido, 003-0006

  • Aiiku Hospital /ID# 222351

    Sapporo, Hokkaido, 064-0804

  • Tohoku University Hospital /ID# 221976

    Sendai, Miyagi, 9808574

  • NTT Medical Center Tokyo /ID# 222365

    Shinagawa-ku, Tokyo, 141-8625

  • Yamagata University Hospital /ID# 221574

    Yamagata, Yamagata, 990-9585

  • University of Fukui Hospital /ID# 221568

    Yoshida-gun, Fukui, 910-1104

Other trials in Japan

France9 sites

  • CH Henri Duffaut /ID# 225185

    Avignon, Vaucluse, 84902

  • CHU Grenoble - Hopital Michallon /ID# 220988

    La Tronche, Isere, 38700

  • CHRU Lille - Hopital Claude Huriez /ID# 220991

    Lille, Nord, 59037

  • Hopital de la Conception /ID# 224882

    Marseille, Provence-Alpes-Côte d'Azur Region, 13005

  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 222074

    Nantes, Pays de la Loire Region, 44000

  • Chu de Nice-Hopital L'Archet Ii /Id# 220992

    Nice, Alpes-Maritimes, 06202

  • Hôpital Saint-Louis /ID# 222075

    Paris, 75010

  • Centre Hospitalier Universitaire de Bordeaux /ID# 220989

    Pessac, Gironde, 33604

  • Centre Henri Becquerel /ID# 220986

    Rouen, Seine-Maritime, 76038

Other trials in France

Spain9 sites

  • Hospital Universitario Germans Trias i Pujol /ID# 221274

    Badalona, Barcelona, 08916

  • Hospital Universitario Vall d'Hebron /ID# 221323

    Barcelona, 08035

  • Hospital Universitario Reina Sofia /ID# 221273

    Córdoba, Cordoba, 14004

  • Hospital General Universitario Gregorio Maranon /ID# 221271

    Madrid, 28007

  • Hospital Universitario 12 de Octubre /ID# 221272

    Madrid, 28041

  • Hospital Universitario Quironsalud Madrid /ID# 221275

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario de Salamanca /ID# 221297

    Salamanca, 37711

  • Hospital Universitario Virgen del Rocio /ID# 221276

    Seville, 41013

  • Hospital Universitario y Politecnico La Fe /ID# 221270

    Valencia, 46026

Other trials in Spain

United Kingdom9 sites

  • NHS Grampian /ID# 222509

    Aberdeen, AB15 6RE

  • University Hospitals Birmingham NHS Foundation Trust /ID# 221233

    Birmingham, B15 2TH

  • University Hospitals Bristol /ID# 222510

    Bristol, BS1 3NU

  • Cardiff & Vale University Health Board /ID# 221236

    Cardiff, Wales, CF14 4XN

  • University College London Hospital /ID# 221240

    London, Greater London, NW1 2BU

  • The Royal Marsden NHS Foundation Trust /ID# 221232

    London, SW3 6JJ

  • Oxford University Hospitals NHS Foundation Trust /ID# 221231

    Oxford, Oxfordshire, OX3 9DU

  • Derriford Hospital and the Royal Eye Infirmary /ID# 222514

    Plymouth, Devon, PL6 8DH

  • University Hospitals Dorset NHS Foundation Trust /ID# 221237

    Poole, Dorset, BH15 2JB

Other trials in United Kingdom

Germany8 sites

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189

    Berlin, 12203

  • Universitaetsklinikum Koeln /ID# 234219

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Duesseldorf /ID# 221169

    Düsseldorf, North Rhine-Westphalia, 40225

  • Medizinische Hochschule Hannover /ID# 221173

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Leipzig /ID# 221168

    Leipzig, Saxony, 04103

  • Universitatsklinikum Mannheim /ID# 221172

    Mannheim, Baden-Wurttemberg, 68167

  • Klinikum rechts der Isar /ID# 221170

    Munich, Bavaria, 81675

  • Stauferklinikum Schwaebisch Gmuend /ID# 224917

    Mutlangen, Baden-Wurttemberg, 73557

Other trials in Germany

Australia7 sites

  • Royal Adelaide Hospital /ID# 221805

    Adelaide, South Australia, 5000

  • Duplicate_Blacktown Hospital /ID# 234079

    Blacktown, New South Wales, 2148

  • St Vincent's Hospital Melbourne /ID# 221809

    Fitzroy Melbourne, Victoria, 3065

  • Austin Health /ID# 221807

    Heidelberg, Victoria, 3084

  • St George Hospital /ID# 221810

    Kogarah, New South Wales, 2217

  • Port Macquarie Base Hospital /ID# 234078

    Port Macquarie, New South Wales, 2444

  • Gold coast University Hospital /ID# 222606

    Southport, Queensland, 4215

Other trials in Australia

Belgium7 sites

  • ZAS Middelheim /ID# 218907

    Antwerp, Antwerpen, 2020

  • AZ Sint-Jan Brugge /ID# 218212

    Bruges, West-Vlaanderen, 8000

  • Cliniques Universitaires UCL Saint-Luc /ID# 219066

    Brussels, Brussels Capital, 1200

  • UZ Gent /ID# 218767

    Ghent, Oost-Vlaanderen, 9000

  • Hospital La Louviere Site Jolimont - Helora /ID# 218921

    La Louvière, Hainaut, 7100

  • Universitair Ziekenhuis Leuven /ID# 218905

    Leuven, Vlaams-Brabant, 3000

  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 219064

    Yvoir, Namur, 5530

Other trials in Belgium

Poland7 sites

  • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Uniwersyteckie Centrum Kliniczne /ID# 222069

    Gdansk, Pomeranian Voivodeship, 80-214

  • Pratia Onkologia Katowice /ID# 224728

    Katowice, 40-519

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221784

    Lodz, Łódź Voivodeship, 93-513

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 221667

    Lublin, Lublin Voivodeship, 20-081

  • Lux Med Onkologia - Szpital Szamocka /Id# 222203

    Warsaw, Masovian Voivodeship, 01-748

  • MTZ Clinical Research Powered by Pratia /ID# 221354

    Warsaw, Masovian Voivodeship, 02-172

Other trials in Poland

Canada6 sites

  • McGill University Health Centre - Glen Site /ID# 222519

    Montreal, Quebec, H4A 3J1

  • CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973

    Montreal, Quebec, H4J 1C5

  • Ottawa Hospital Research Institute /ID# 219105

    Ottawa, Ontario, K1H 8L6

  • CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200

    Québec, Quebec, G1J 1Z4

  • BC Cancer - Surrey /ID# 219098

    Surrey, British Columbia, V3V 1Z2

  • Sunnybrook Health Sciences Centre /ID# 219103

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Czechia6 sites

  • Fakultní Nemocnice Brno - Jihlavská /ID# 221351

    Brno, Brno-mesto, 625 00

  • Fakultní nemocnice Hradec Králové - Sokolská /ID# 221163

    Hradec Králové, Hradec Kralove, 500 05

  • Fakultni Nemocnice Ostrava /ID# 219143

    Ostrava, Ostrava-mesto, 708 52

  • Fakultní Nemocnice Plzeň-Lochotín /ID# 221162

    Pilsen, Plzen-jih, 323 00

  • Všeobecná Fakultní Nemocnice v Praze /ID# 221229

    Prague, Praha 17, 128 00

  • Ustav hematologie a krevni transfuze /ID# 221350

    Prague, 128 00

Other trials in Czechia

Israel6 sites

  • Rambam Health Care Campus /ID# 221083

    Haifa, 3109601

  • Shaare Zedek Medical Center /ID# 233181

    Jerusalem, Jerusalem, 91031

  • Hadassah Medical Center-Hebrew University /ID# 222006

    Jerusalem, Jerusalem, 91120

  • Rabin Medical Center /ID# 221184

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 221110

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 221896

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Russia6 sites

  • Kaluga Regional Clinical Hospital /ID# 221211

    Kaluga, Kaluga Oblast, 248007

  • Hospital n.a. V.V. Veresaev /ID# 225435

    Moscow, 127644

  • MMCC Kommunarka /ID# 221213

    Moscow, 129301

  • Republican hospital named after V.A. Baranov /ID# 221214

    Petrozavodsk, Murmansk Oblast, 185019

  • Clinic UZI 4D /ID# 221215

    Pyatigorsk, Stavropol Kray, 357502

  • Almazov National Medical Research Centre /ID# 221449

    Saint Petersburg, 197341

Other trials in Russia

South Korea6 sites

  • Duplicate_Pusan National University Hospital /ID# 232353

    Busan, Busan Gwang Yeogsi, 49241

  • Seoul National University Bundang Hospital /ID# 221695

    Seongnam-si, Gyeonggido, 13620

  • Seoul National University Hospital /ID# 221226

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center /ID# 221227

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 221224

    Seoul, Seoul Teugbyeolsi, 06351

  • Yonsei University Health System Severance Hospital /ID# 233171

    Seoul, 03722

Other trials in South Korea

Turkey (Türkiye)6 sites

  • Hacettepe University Faculty of Medicine /ID# 222094

    Ankara, 06100

  • Ankara City Hospital /ID# 222093

    Ankara, 06800

  • Akdeniz Universitesi Tip Fakul /ID# 222095

    Antalya, 07059

  • Duplicate_Erciyes University Medical Fac /ID# 222090

    Melikgazi, Kayseri, 38030

  • Ondokuz mayis University Facul /ID# 222091

    Samsun, 55200

  • Acibadem Maslak Hastanesi /ID# 222072

    Tuzla, 34953

Other trials in Turkey (Türkiye)

Austria5 sites

  • Ordensklinikum Linz GmbH Elisabethinen /ID# 221387

    Linz, Upper Austria, 4010

  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221092

    Salzburg, 5020

  • Medizinische Universitaet Wien /ID# 221446

    Vienna, State of Vienna, 1090

  • Hanusch Krankenhaus /ID# 221093

    Vienna, 1140

  • Klinikum Wels-Grieskirchen GmbH /ID# 221386

    Wels, Upper Austria, 4600

Other trials in Austria

Brazil5 sites

  • Hospital Erasto Gaertner /ID# 221341

    Curitiba, Puerto Rico, 81520-060

  • Hospital Universitario Walter Cantidio /ID# 223434

    Fortaleza, Ceará, 60430-372

  • Hospital Universitário Pedro Ernesto /ID# 223080

    Rio de Janeiro, 20551-030

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 221370

    São Paulo, São Paulo, 05652-900

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 221339

    São Paulo, 05403-000

Other trials in Brazil

Hungary5 sites

  • Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 221702

    Debrecen, Hajdú-Bihar, 4032

  • Duplicate_Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 221703

    Kaposvár, Somogy County, 7400

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 221704

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Szegedi Tudományegyetem /ID# 221705

    Szeged, 6720

  • Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 222953

    Székesfehérvár, Fejér, 8000

Other trials in Hungary

Italy5 sites

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 220810

    Bologna, 40138

  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816

    Naples, Napoli, 80131

  • Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 220818

    Reggio Calabria, 89125

  • Duplicate_Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819

    Rome, Roma, 00189

  • IRCCS Istituto Clinico Humanitas /ID# 220815

    Rozzano, Lombardy, 20089

Other trials in Italy

Netherlands5 sites

  • Maxima Medisch Centrum /ID# 223010

    Eindhoven, North Brabant, 5631 BM

  • Medisch Spectrum Twente /ID# 223012

    Enschede, Overijssel, 7512 KZ

  • Maastricht Universitair Medisch Centrum /ID# 221630

    Maastricht, Limburg, 6229 HX

  • Erasmus Medisch Centrum /ID# 218937

    Rotterdam, South Holland, 3015 CE

  • Isala /ID# 223011

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

Taiwan4 sites

  • Duplicate_Kaohsiung Chang Gung Memorial Hospital /ID# 223573

    Kaohsiung City, Kaohsiung, 833

  • China Medical University Hospital /ID# 218987

    Taichung, 40447

  • National Cheng Kung University Hospital /ID# 218989

    Tainan, 704

  • Chi-Mei Medical Center /ID# 218991

    Tainan, 71004

Other trials in Taiwan

Puerto Rico2 sites

  • Pan American Center for Oncology Trials, LLC /ID# 221010

    Rio Piedras, 00935

  • VA Caribbean Healthcare System /ID# 221012

    San Juan, 00921-3201

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Azacitidine in Patients Newly Diagnosed With Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)

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.

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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.

Being tested
Venetoclax, Azacitidine, Placebo
Keywords
MDS, Myelodysplastic Syndrome, Venetoclax, Azacitidine, AZA, Venclexta
Medical subject headings
Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenetoclaxDrug

    Also called ABT-199, GDC-0199, Venclexta

    Tablet: Oral

  • AzacitidineDrug

    Also called AZA

    Subcutaneous (SC) or Intravenous (IV) injection

  • PlaceboDrug

    Tablet; Oral

Study groups in NCT04401748
Study groupRoleWhat they receive
Arm 1: Venetoclax + Azacitidine (AZA)ExperimentalParticipants 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.
Receives: Drug: Venetoclax; Drug: Azacitidine
Arm 2: Placebo + AzacitidineActive comparatorParticipants 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.
Receives: Drug: Azacitidine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up To 5 Years

Secondary outcomes (7)

  1. 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).

    Measured: Up To 5 Years

  2. 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.

    Measured: Up to 5 Years

  3. 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).

    Measured: Up To 36 Months

  4. 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.

    Measured: Up To 5 Years

  5. 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."

    Measured: Up To 5 Years

  6. 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".

    Measured: Up To 5 Years

  7. 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.

    Measured: Up To 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2020
  2. Study start10 Sep 2020
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
531 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04401748
Sponsor's protocol ID
M15-954
Other IDs
2023-507153-16-00, 2023
Acronym
Verona
Status last verified
May 2026
First submitted
22 May 2020
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Ye Y, Brissot E, Bazarbachi A, Mohty M. Therapy of high-risk myelodysplastic syndromes. Bone Marrow Transplant. 2026 May;61(5):521-528. doi: 10.1038/s41409-026-02821-4. Epub 2026 Mar 6.

    PubMed 41792302

  • 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.

    PubMed 38065202

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Venetoclax and Azacitidine in people with Myelodysplastic Syndrome (MDS), run by AbbVie at 220 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 220 sites in United States, China, Japan, France, Spain and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: Up To 5 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04401748, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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