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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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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