Spots Global Cancer Trial Database for A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)
Official Title: A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)
Study ID: NCT04161885
Study Description
Brief Summary: The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).
Detailed Description:
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology - Scottsdale - Cancer Transplant Institute /ID# 239711, Scottsdale, Arizona, United States
University of Arizona Cancer Center - Tucson /ID# 242507, Tucson, Arizona, United States
University of Arkansas for Medical Sciences /ID# 239804, Little Rock, Arkansas, United States
City of Hope /ID# 213681, Duarte, California, United States
UCHSC Anschultz Cancer Pavilion /ID# 215618, Aurora, Colorado, United States
Colorado Blood Cancer Institute /ID# 215980, Denver, Colorado, United States
Mayo Clinic /ID# 239710, Jacksonville, Florida, United States
AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985, Orlando, Florida, United States
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840, Chicago, Illinois, United States
The University of Chicago Medical Center /ID# 215616, Chicago, Illinois, United States
Loyola University Medical Ctr /ID# 215617, Maywood, Illinois, United States
Indiana Blood & Marrow Transpl /ID# 215842, Indianapolis, Indiana, United States
Ochsner Clinic Foundation-New Orleans /ID# 213834, New Orleans, Louisiana, United States
University of Maryland Med Ctr /ID# 213855, Baltimore, Maryland, United States
Massachusetts General Hospital /ID# 215765, Boston, Massachusetts, United States
Karmanos Cancer Institute - Dresner Clinic /ID# 214581, Detroit, Michigan, United States
Masonic Cancer Center /ID# 239492, Minneapolis, Minnesota, United States
Mayo Clinic - Rochester /ID# 214685, Rochester, Minnesota, United States
University of Mississippi Medical Center /ID# 239343, Jackson, Mississippi, United States
The John Theurer Cancer /ID# 215251, Hackensack, New Jersey, United States
Montefiore Medical Center - Moses Campus /ID# 241669, Bronx, New York, United States
Roswell Park Comprehensive Cancer Center /ID# 217857, Buffalo, New York, United States
Columbia University Medical Center /ID# 240875, New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680, New York, New York, United States
Weill Cornell Medical College /ID# 214887, New York, New York, United States
University of North Carolina /ID# 215814, Chapel Hill, North Carolina, United States
Wake Forest Univ HS /ID# 239210, Winston-Salem, North Carolina, United States
UC Health - Cincinnati /ID# 239263, Cincinnati, Ohio, United States
University Hospitals - Seidman Cancer Center /ID# 239260, Cleveland, Ohio, United States
University of Oklahoma, Stephenson Cancer Center /ID# 215611, Oklahoma City, Oklahoma, United States
Oregon Health & Science University /ID# 215874, Portland, Oregon, United States
Penn State Hershey Medical Ctr /ID# 217120, Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia - Main /ID# 215410, Philadelphia, Pennsylvania, United States
Perelman Center for Advanced Medicine - /ID# 214518, Philadelphia, Pennsylvania, United States
Allegheny General Hospital /ID# 216756, Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Ctr /ID# 213715, Pittsburgh, Pennsylvania, United States
TriStar Centennial Medical Center /ID# 218750, Nashville, Tennessee, United States
Texas Oncology - Medical City Dallas /ID# 216720, Dallas, Texas, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735, Dallas, Texas, United States
Texas Transplant Institute /ID# 214691, San Antonio, Texas, United States
Virginia Commonwealth University Medical Center Main Hospital /ID# 239203, Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center /ID# 214436, Seattle, Washington, United States
Univ of Wisconsin Hosp/Clinics /ID# 216096, Madison, Wisconsin, United States
The Kinghorn Cancer Centre /ID# 214660, Darlinghurst, New South Wales, Australia
Royal Adelaide Hospital /ID# 215678, Adelaide, South Australia, Australia
Peter MacCallum Cancer Ctr /ID# 214653, Melbourne, Victoria, Australia
Alfred Health /ID# 240931, Melbourne, Victoria, Australia
Hospital de Clinicas de Porto Alegre /ID# 215042, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145, Jaú, Sao Paulo, Brazil
Hospital Nove de Julho /ID# 242359, São Paulo, Sao Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 239516, Sao Paulo, , Brazil
Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363, Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre /ID# 215344, Toronto, Ontario, Canada
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591, Montreal, Quebec, Canada
Royal Victoria Hospital / McGill University Health Centre /ID# 215253, Montreal, Quebec, Canada
Saskatoon Cancer Centre /ID# 238821, Saskatoon, Saskatchewan, Canada
Peking University People's Hospital /ID# 215551, Beijing, Beijing, China
Chinese PLA General Hospital /ID# 216287, Beijing, Beijing, China
Aerospace Center Hospital /ID# 217018, Beijing, Beijing, China
Fujian Medical University Union Hospital /ID# 215555, Fuzhou, Fujian, China
Guangdong Provincial People's Hospital /ID# 218666, Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University /ID# 216333, Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 215553, Guangzhou, Guangdong, China
Shenzhen Second People's Hospital /ID# 239401, Shenzhen, Guangdong, China
Henan Cancer Hospital /ID# 215554, Zhengzhou, Henan, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552, Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373, Wuhan, Hubei, China
Xiangya Hospital Central South University /ID# 219025, Changsha, Hunan, China
Zhongda Hospital Southeast University /ID# 218926, Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University /ID# 216605, Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University /ID# 239098, Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 239168, Nanchang, Jiangxi, China
Shanghai Changhai Hospital /ID# 216334, Shanghai, Shanghai, China
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282, Xi'an, Shanxi, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546, Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550, Hangzhou, Zhejiang, China
Fakultni Nemocnice Brno /ID# 214811, Brno, , Czechia
Fakultni nemocnice Hradec Kralove /ID# 214814, Hradec Kralove, , Czechia
Fakultni Nemocnice Ostrava /ID# 239922, Ostrava, , Czechia
Ustav hematologie a krevni transfuze /ID# 215133, Praha, , Czechia
CHU de Nice - Hôpital Archet 1 /ID# 214056, Nice, Alpes-Maritimes, France
CHU de Besancon - Jean Minjoz /ID# 241171, Besancon, Doubs, France
CHU Bordeaux - Hopital Haut Leveque /ID# 214055, Pessac, Gironde, France
CHRU Lille - Hopital Claude Huriez /ID# 217916, Lille, Nord, France
CHU de Nantes, Hotel Dieu -HME /ID# 214060, Nantes, Pays-de-la-Loire, France
AP-HP - Hopital Saint-Louis /ID# 214054, Paris, , France
AP-HP - Hopital Saint-Antoine /ID# 216957, Paris, , France
Hopital Pitie Salpetriere /ID# 241072, Paris, , France
Universitaetsklinik Heidelberg /ID# 216623, Heidelberg, Baden-Wuerttemberg, Germany
Universitaetsklinikum Muenster /ID# 215213, Muenster, Nordrhein-Westfalen, Germany
Universitaetsklinikum Leipzig /ID# 245892, Leipzig, Sachsen, Germany
Klinikum Augsburg /ID# 239583, Augsburg, , Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214244, Dresden, , Germany
Universitaetsklinikum Halle (Saale) /ID# 239585, Halle (Saale), , Germany
Medizinische Hochschule Hannover /ID# 214243, Hannover, , Germany
Universitaetsklinikum Wuerzburg /ID# 215212, Wuerzburg, , Germany
General Hospital of Athens Evangelismos /ID# 238810, Athens, Attiki, Greece
University General Hospital Attikon /ID# 238812, Athens, Attiki, Greece
University General Hospital of Patras /ID# 238811, RION Patras Achaia, , Greece
Debreceni Egyetem Klinikai Kozpont /ID# 241123, Debrecen, Hajdu-Bihar, Hungary
Rambam Health Care Campus /ID# 214507, Haifa, H_efa, Israel
Rabin Medical Center /ID# 214509, Haifa, H_efa, Israel
Schneider Children's Medical Center /ID# 224326, Petah Tikva, HaMerkaz, Israel
Sheba Medical Center /ID# 239571, Ramat Gan, Tel-Aviv, Israel
The Chaim Sheba Medical Center /ID# 214305, Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 214508, Tel Aviv, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 218697, Jerusalem, Yerushalayim, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910, Rome, Lazio, Italy
Ospedale San Raffaele IRCCS /ID# 214311, Milan, Milano, Italy
IEO -Istituto Europeo di Oncologia /ID# 242579, Milan, Milano, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254964, Rome, Roma, Italy
A.O.U. Citta della Salute e della Scienza di Torino /ID# 216148, Turin, Torino, Italy
ASST Spedali civili di Brescia /ID# 215997, Brescia, , Italy
Anjou Kousei Hospital /ID# 215857, Anjo-shi, Aichi, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679, Nagoya-shi, Aichi, Japan
University of Fukui Hospital /ID# 253383, Yoshida-gun, Fukui, Japan
Kyushu University Hospital /ID# 215285, Fukuoka-shi, Fukuoka, Japan
Fukushima Medical University Hospital /ID# 252293, Fukushima-shi, Fukushima, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 217522, Hiroshima-shi, Hiroshima, Japan
Hokkaido University Hospital /ID# 215937, Sapporo-shi, Hokkaido, Japan
Kobe City Medical Center General Hospital /ID# 215388, Kobe-shi, Hyogo, Japan
Hyogo Medical University Hospital /ID# 215389, Nishinomiya-shi, Hyogo, Japan
Kanazawa University Hospital /ID# 242955, Kanazawa-shi, Ishikawa, Japan
Imamura General Hospital /ID# 215688, Kagoshima-shi, Kagoshima, Japan
Tokai University Hospital /ID# 250086, Isehara-shi, Kanagawa, Japan
Kanagawa Cancer Center /ID# 215029, Yokohama-shi, Kanagawa, Japan
Kyoto University Hospital /ID# 243209, Kyoto-shi, Kyoto, Japan
Tohoku University Hospital /ID# 214670, Sendai-shi, Miyagi, Japan
Okayama University Hospital /ID# 214842, Okayama-shi, Okayama, Japan
Osaka Metropolitan University Hospital /ID# 215227, Osaka-shi, Osaka, Japan
Kindai University Hospital /ID# 214917, Osakasayama-shi, Osaka, Japan
Jichi Medical University Saitama Medical Center /ID# 216092, Saitama-shi, Saitama, Japan
Jichi Medical University Hospital /ID# 216091, Shimotsuke-shi, Tochigi, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939, Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital /ID# 242639, Chuo-ku, Tokyo, Japan
Toranomon Hospital /ID# 215311, Minato-ku, Tokyo, Japan
National Center for Child Health and Development /ID# 242479, Setagaya-ku, Tokyo, Japan
Keio University Hospital /ID# 243549, Shinjuku-ku, Tokyo, Japan
Yamagata University Hospital /ID# 253304, Yamagata-shi, Yamagata, Japan
Seoul National University Hospital /ID# 214891, Seoul, , Korea, Republic of
Asan Medical Center /ID# 214893, Seoul, , Korea, Republic of
Samsung Medical Center /ID# 239087, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214892, Seoul, , Korea, Republic of
Hospital Clinic de Barcelona /ID# 215108, Barcelona, , Spain
Hospital Santa Creu i Sant Pau /ID# 240397, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 215107, Madrid, , Spain
Hospital Universitario Ramon y Cajal /ID# 218102, Madrid, , Spain
Hospital Universitario La Paz /ID# 218103, Madrid, , Spain
Hospital Universitario Virgen del Rocio /ID# 215463, Sevilla, , Spain
Hospital Clinico Universitario de Valencia /ID# 215106, Valencia, , Spain
Universitätsspital Basel /ID# 215892, Basel, Basel-Stadt, Switzerland
Universitatsspital Zurich /ID# 215891, Zurich, Zuerich, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197, Kaohsiung, , Taiwan
China Medical University Hospital /ID# 215198, Taichung, , Taiwan
Taichung Veterans General Hospital /ID# 239288, Taichung, , Taiwan
National Taiwan University Hospital /ID# 215245, Taipei City, , Taiwan
Taipei Veterans General Hosp /ID# 239289, Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 215319, Taoyuan City, , Taiwan
NHS Greater Glasgow and Clyde /ID# 215663, Glasgow, Scotland, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 215120, Birmingham, , United Kingdom
University College London Hospitals NHS Foundation Trust /ID# 215662, London, , United Kingdom
King's College Hospital NHS Foundation Trust /ID# 215338, London, , United Kingdom
The Royal Marsden NHS Foundation Trust /ID# 215124, London, , United Kingdom
Imperial College Healthcare NHS Trust /ID# 215665, London, , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359, Newcastle upon Tyne, , United Kingdom
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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