Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
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)
Study ID: NCT04401748
Conditions
Study Description
Brief Summary: Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce normal blood cells. Some people with MDS have a risk of the disease progressing to acute myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are when compared to AZA and a placebo (contains no medicine), in participants with newly diagnosed higher-risk MDS. Venetoclax is an investigational drug being developed for the treatment of MDS. The study consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In another arm, participants will receive AZA and placebo. Adult participants with newly diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in approximately 220 sites worldwide. Participants in one arm will receive oral doses of venetoclax tablet and intravenous (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA solution. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Duplicate_Providence Medical Foundation /ID# 222633, Fullerton, California, United States
University of California, Los Angeles /ID# 221760, Los Angeles, California, United States
Torrance Memorial Physician Network Cancer Care /ID# 222702, Torrance, California, United States
PIH Health Whittier Hospital /ID# 222647, Whittier, California, United States
Rocky Mountain Cancer Centers - Boulder /ID# 223723, Boulder, Colorado, United States
Yale University School of Medicine /ID# 222764, New Haven, Connecticut, United States
Helen F. Graham Cancer Center & Research Institute /ID# 223731, Newark, Delaware, United States
Florida Cancer Specialists - Fort Myers /ID# 221319, Fort Myers, Florida, United States
Memorial Healthcare System /ID# 222703, Hollywood, Florida, United States
Florida Cancer Specialists - North /ID# 221318, Saint Petersburg, Florida, United States
Florida Cancer Specialists - Panhandle /ID# 221315, Tallahassee, Florida, United States
Florida Cancer Specialists - East /ID# 221317, West Palm Beach, Florida, United States
St. Luke's Mountain State Tumor Institute /ID# 220838, Boise, Idaho, United States
Northwestern University Feinberg School of Medicine /ID# 220843, Chicago, Illinois, United States
Duplicate_Rush University Medical Center /ID# 221007, Chicago, Illinois, United States
Ingalls Memorial Hosp /ID# 220844, Harvey, Illinois, United States
Illinois Cancer Care, PC /ID# 220840, Peoria, Illinois, United States
Duplicate_Parkview Cancer Institute /ID# 223620, Fort Wayne, Indiana, United States
Cancer Center of Kansas /ID# 222648, Wichita, Kansas, United States
Hematology/Oncology Clinic /ID# 224257, Baton Rouge, Louisiana, United States
Pontchartrain Cancer Center - Covington /ID# 221005, Covington, Louisiana, United States
Maryland Oncology Hematology /ID# 223776, Columbia, Maryland, United States
Massachusetts General Hospital /ID# 225068, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 225069, Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 219162, Boston, Massachusetts, United States
VA Ann Arbor Healthcare System /ID# 221365, Ann Arbor, Michigan, United States
Cancer & Hematology Centers /ID# 220848, Grand Rapids, Michigan, United States
Metro Minnesota Community Oncology Research Consortium (MMCORC) /ID# 221321, Saint Louis Park, Minnesota, United States
MidAmerica Division, Inc. /ID# 221895, Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada - Horizon Ridge /ID# 222635, Henderson, Nevada, United States
Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 221003, East Brunswick, New Jersey, United States
The Valley Hospital /ID# 232337, Paramus, New Jersey, United States
New York Oncology Hematology - Albany Cancer Center /ID# 223778, Albany, New York, United States
University at Buffalo /ID# 221206, Buffalo, New York, United States
Weill Cornell Medical College /ID# 222898, New York, New York, United States
Stony Brook University Hospital /ID# 224450, Stony Brook, New York, United States
Novant Health Presbyterian Medical Center /ID# 222561, Charlotte, North Carolina, United States
Novant Health Forsyth Medical Center /ID# 221004, Winston-Salem, North Carolina, United States
Oncology Hematology Care, Inc. /ID# 223724, Cincinnati, Ohio, United States
Bend Memorial Clinic /ID# 220999, Bend, Oregon, United States
Willamette Valley Cancer Institute and Research Center /ID# 223733, Eugene, Oregon, United States
UPMC Hillman Cancer Ctr /ID# 223201, Pittsburgh, Pennsylvania, United States
Avera Cancer Institute /ID# 243461, Sioux Falls, South Dakota, United States
Tennessee Oncology - Chattanooga / McCallie /ID# 221311, Chattanooga, Tennessee, United States
Tennessee Oncology-Nashville Centennial /ID# 220854, Nashville, Tennessee, United States
Texas Oncology - Austin Midtown /ID# 223729, Austin, Texas, United States
Texas Oncology - Medical City Dallas /ID# 223725, Dallas, Texas, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727, Dallas, Texas, United States
Texas Oncology - Forth Worth /ID# 223777, Fort Worth, Texas, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 219163, Houston, Texas, United States
Texas Oncology - San Antonio Medical Center /ID# 223728, San Antonio, Texas, United States
Baylor Scott & White Medical Center- Temple /ID# 221332, Temple, Texas, United States
Texas Oncology - Northeast Texas /ID# 223734, Tyler, Texas, United States
Utah Cancer Specialists Salt Lake Clinic /ID# 219160, Salt Lake City, Utah, United States
Virginia Cancer Specialists - Gainesville /ID# 223726, Gainesville, Virginia, United States
Virginia Commonwealth University Medical Center Main Hospital /ID# 221590, Richmond, Virginia, United States
Virginia Cancer Institute at Reynolds Crossing /ID# 221002, Richmond, Virginia, United States
VA Puget Sound Health Care System /ID# 221358, Seattle, Washington, United States
Duplicate_Blacktown Hospital /ID# 234079, Blacktown, New South Wales, Australia
St George Hospital /ID# 221810, Kogarah, New South Wales, Australia
Port Macquarie Base Hospital /ID# 234078, Port Macquarie, New South Wales, Australia
Gold coast University Hospital /ID# 222606, SouthPort, Queensland, Australia
Royal Adelaide Hospital /ID# 221805, Adelaide, South Australia, Australia
St Vincent's Hospital Melbourne /ID# 221809, Fitzroy Melbourne, Victoria, Australia
Austin Health /ID# 221807, Heidelberg, Victoria, Australia
Ordensklinikum Linz GmbH Elisabethinen /ID# 221387, Linz, Oberoesterreich, Austria
Klinikum Wels-Grieskirchen GmbH /ID# 221386, Wels, Oberoesterreich, Austria
Medizinische Universitaet Wien /ID# 221446, Vienna, Wien, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221092, Salzburg, , Austria
Hanusch Krankenhaus /ID# 221093, Wien, , Austria
Cliniques Universitaires UCL Saint-Luc /ID# 219066, Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium
Hospital La Louviere Site Jolimont - Helora /ID# 218921, La Louvière, Hainaut, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 219064, Yvoir, Namur, Belgium
UZ Gent /ID# 218767, Gent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 218905, Leuven, Vlaams-Brabant, Belgium
ZNA Middelheim /ID# 218907, Antwerp, , Belgium
AZ Sint-Jan Brugge /ID# 218212, Brugge, , Belgium
Hospital Universitario Walter Cantidio /ID# 223434, Fortaleza, Ceara, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 221370, São Paulo, Sao Paulo, Brazil
Hospital Universitário Pedro Ernesto /ID# 223080, Rio de Janeiro, , Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 221339, Sao Paulo, , Brazil
BC Cancer - Surrey /ID# 219098, Surrey, British Columbia, Canada
Ottawa Hospital Research Institute /ID# 219105, Ottawa, Ontario, Canada
Sunnybrook Health Sciences Ctr /ID# 219103, Toronto, Ontario, Canada
McGill University Health Center Research Institute /ID# 222519, Montreal, Quebec, Canada
CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973, Montreal, Quebec, Canada
CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200, Quebec City, Quebec, Canada
Lanzhou University Second Hospital /ID# 225980, Lanzhou, Gansu, China
Guangdong Provincial People's Hospital /ID# 221442, Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University /ID# 222071, Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 224566, Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University /ID# 222919, Shijiazhuang, Hebei, China
People's Hospital of Henan Province /ID# 225790, Zhengzhou, Henan, China
Henan Cancer Hospital /ID# 221447, Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 221475, Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of HUST /ID# 221474, Wuhan, Hubei, China
Zhongda Hospital Southeast University /ID# 221849, Nanjing, Jiangsu, China
Jiangsu Province Hospital /ID# 221342, Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University /ID# 221640, Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 225983, Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University /ID# 222945, Shenyang, Liaoning, China
Shaanxi Provincial people's Hospital /ID# 225728, Xi'an, Shaanxi, China
Shanghai Sixth People's Hospital /ID# 221546, Shanghai, Shanghai, China
West China Hospital, Sichuan University /ID# 221601, Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567, Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 221494, Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 225982, Hangzhou, Zhejiang, China
The Fourth Affiliated Hospital Zhejiang University School of Medicine /ID# 225918, Yiwu, Zhejiang, China
Peking University International Hospital /ID# 222987, Beijing, , China
Tianjin Medical University General Hospital /ID# 226810, Tianjin, , China
Fakultni nemocnice Brno /ID# 221351, Brno, , Czechia
Fakultni nemocnice Hradec Kralove /ID# 221163, Hradec Kralove, , Czechia
Fakultni Nemocnice Ostrava /ID# 219143, Ostrava, , Czechia
Fakultni nemocnice Plzen /ID# 221162, Plzen, , Czechia
Ustav hematologie a krevni transfuze /ID# 221350, Praha, , Czechia
Vseobecna fakultni nemocnice v Praze /ID# 221229, Praha, , Czechia
CHU de Nice - Hôpital Archet 1 /ID# 220992, Nice, Alpes-Maritimes, France
Hopital de la Conception /ID# 224882, Marseille, Bouches-du-Rhone, France
Centre Hospitalier Universitaire de Bordeaux /ID# 220989, Pessac CEDEX, Gironde, France
CHU Grenoble - Hopital Michallon /ID# 220988, La Tronche, Isere, France
CHRU Lille - Hopital Claude Huriez /ID# 220991, Lille, Nord, France
CHU de Nantes, Hotel Dieu -HME /ID# 222074, Nantes, Pays-de-la-Loire, France
CH Henri Duffaut /ID# 225185, Avignon CEDEX 9, Vaucluse, France
AP-HP - Hopital Saint-Louis /ID# 222075, Paris, , France
Centre Henri Becquerel /ID# 220986, Rouen, , France
Universitatsklinikum Mannheim /ID# 221172, Mannheim, Baden-Wuerttemberg, Germany
Stauferklinikum Schwaebisch Gmuend /ID# 224917, Mutlangen, Baden-Wuerttemberg, Germany
Universitaetsklinikum Duesseldorf /ID# 221169, Düsseldorf, Nordrhein-Westfalen, Germany
Universitaetsklinikum Koeln /ID# 234219, Köln, Nordrhein-Westfalen, Germany
Universitaetsklinikum Leipzig /ID# 221168, Leipzig, Sachsen, Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189, Berlin, , Germany
Medizinische Hochschule Hannover /ID# 221173, Hannover, , Germany
Klinikum rechts der Isar /ID# 221170, Munich, , Germany
Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 222953, Szekesfehervar, Fejer, Hungary
Duplicate_Debreceni Egyetem Klinikai Kozpont /ID# 221702, Debrecen, Hajdu-Bihar, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 221703, Kaposvár, Somogy, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 221704, Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary
Szegedi Tudományegyetem /ID# 221705, Szeged, , Hungary
Rambam Health Care Campus /ID# 221083, Haifa, H_efa, Israel
The Chaim Sheba Medical Center /ID# 221110, Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 221896, Tel Aviv, Tel-Aviv, Israel
Shaare Zedek Medical Center /ID# 233181, Jerusalem, Yerushalayim, Israel
Hadassah Medical Center-Hebrew University /ID# 222006, Jerusalem, Yerushalayim, Israel
Rabin Medical Center /ID# 221184, Haifa, , Israel
Istituto Clinico Humanitas /ID# 220815, Rozzano, Milano, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220810, Bologna, , Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816, Napoli, , Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 220818, Reggio Calabria, , Italy
Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819, Rome, , Italy
Nagoya University Hospital /ID# 221566, Nagoya-shi, Aichi, Japan
University of Fukui University Hospital /ID# 221568, 吉田郡, Fukui, Japan
Kyushu University Hospital /ID# 223473, Fukuoka-shi, Fukuoka, Japan
Fukushima Medical University Hospital /ID# 222015, Fukushima-shi, Fukushima, Japan
Chugoku Central Hospital /ID# 222955, Fukuyama, Hiroshima, Japan
Sapporo Hokuyu Hospital /ID# 222133, Sapporo-shi, Hokkaido, Japan
Aiiku Hospital /ID# 222351, Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital /ID# 221977, Kobe-shi, Hyogo, Japan
National Hospital Organization Mito Medical Center /ID# 222278, Higashi Ibaraki-gun, Ibaraki, Japan
Tohoku University Hospital /ID# 221976, Sendai-shi, Miyagi, Japan
Nagasaki University Hospital /ID# 222241, Nagasaki-shi, Nagasaki, Japan
Okayama Medical Center /ID# 222310, Okayama-shi, Okayama, Japan
Kindai University Hospital /ID# 222284, Osakasayama-shi, Osaka, Japan
Saitama Medical Center /ID# 222016, Kawagoe-shi, Saitama, Japan
NTT Medical Center Tokyo /ID# 222365, Shinagawa-ku, Tokyo, Japan
Yamagata University Hospital /ID# 221574, Yamagata-shi, Yamagata, Japan
Seoul National University Bundang Hospital /ID# 221695, Seongnam-si, Gyeonggido, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 233171, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center /ID# 221227, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Pusan National University Hospital /ID# 232353, Busan, , Korea, Republic of
Seoul National University Hospital /ID# 221226, Seoul, , Korea, Republic of
Samsung Medical Center /ID# 221224, Seoul, , Korea, Republic of
Maxima Medisch Centrum /ID# 223010, Eindhoven, , Netherlands
Medisch Spectrum Twente /ID# 223012, Enschede, , Netherlands
Maastricht Universitair Medisch Centrum /ID# 221630, Maastricht, , Netherlands
Erasmus Medisch Centrum /ID# 218937, Rotterdam, , Netherlands
Isala /ID# 223011, Zwolle, , Netherlands
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321, Bydgoszcz, Kujawsko-pomorskie, Poland
Wojewódzki Szpital Specjalistyczny im. M.Kopernika w Łodzi /ID# 221784, Lodz, Lodzkie, Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 221667, Lublin, Lubelskie, Poland
Lux Med Onkologia - Szpital Szamocka /Id# 222203, Warszawa, Mazowieckie, Poland
MTZ Clinical Research Powered by Pratia /ID# 221354, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne /ID# 222069, Gdansk, Pomorskie, Poland
Pratia Onkologia Katowice /ID# 224728, Katowice, , Poland
Hospital Erasto Gaertner /ID# 221341, Curitiba, , Puerto Rico
Pan American Center for Oncology Trials, LLC /ID# 221010, Rio Piedras, , Puerto Rico
VA Caribbean Healthcare System /ID# 221012, San Juan, , Puerto Rico
Kaluga Regional Clinical Hospital /ID# 221211, Kaluga, Kaluzhskaya Oblast, Russian Federation
Clinic UZI 4D /ID# 221215, Pyatigorsk, Stavropol Skiy Kray, Russian Federation
Hospital n.a. V.V. Veresaev /ID# 225435, Moscow, , Russian Federation
MMCC Kommunarka /ID# 221213, Moscow, , Russian Federation
Republican hospital named after V.A. Baranov /ID# 221214, Petrozavodsk, , Russian Federation
Almazov National Medical Research Centre /ID# 221449, Sankt-Peterburg, , Russian Federation
Hospital Universitario Germans Trias i Pujol /ID# 221274, Badalona, Barcelona, Spain
Hospital Universitario Reina Sofia /ID# 221273, Córdoba, Cordoba, Spain
Hospital Universitario Quirón Salud Madrid /ID# 221275, Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Vall d'Hebron /ID# 221323, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 221271, Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 221272, Madrid, , Spain
Hospital Universitario de Salamanca /ID# 221297, Salamanca, , Spain
Hospital Universitario Virgen del Rocio /ID# 221276, Sevilla, , Spain
Hospital Universitario y Politecnico La Fe /ID# 221270, Valencia, , Spain
Kaohsiung Chang Gung Memorial Hospital /ID# 223573, Kaohsiung City, Kaohsiung, Taiwan
China Medical University Hospital /ID# 218987, Taichung, , Taiwan
National Cheng Kung University Hospital /ID# 218989, Tainan, , Taiwan
Chi-Mei Medical Center /ID# 218991, Tainan, , Taiwan
Duplicate_Erciyes University Medical Fac /ID# 222090, Melikgazi, Kayseri, Turkey
Hacettepe University Faculty of Medicine /ID# 222094, Ankara, , Turkey
Ankara City Hospital /ID# 222093, Ankara, , Turkey
Akdeniz Universitesi Tip Fakul /ID# 222095, Antalya, , Turkey
Ondokuz mayis University Facul /ID# 222091, Samsun, , Turkey
Acibadem Maslak Hastanesi /ID# 222072, Tuzla, , Turkey
University Hospitals Bristol /ID# 222510, Bristol, Bristol, City Of, United Kingdom
Derriford Hospital and the Royal Eye Infirmary /ID# 222514, Plymouth, Devon, United Kingdom
University Hospitals Dorset NHS Foundation Trust /ID# 221237, Poole, Dorset, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 221231, Oxford, Oxfordshire, United Kingdom
Cardiff & Vale University Health Board /ID# 221236, Cardiff, Wales, United Kingdom
NHS Grampian /ID# 222509, Aberdeen, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 221233, Birmingham, , United Kingdom
University College London Hospitals NHS Foundation Trust /ID# 221240, London, , United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 221232, London, , United Kingdom
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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