Spots Global Cancer Trial Database for A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Official Title: A Multicenter, Phase 3 Study of Venetoclax and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
Study ID: NCT04102020
Conditions
Study Description
Brief Summary: This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with AZA. Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with CC-486. Part 2 and Part 3 Randomization of the study were removed.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mitchell Cancer Institute /ID# 216443, Mobile, Alabama, United States
Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156, Fountain Valley, California, United States
University of California, Los Angeles /ID# 219149, Los Angeles, California, United States
Colorado Blood Cancer Institute /ID# 214280, Denver, Colorado, United States
St. Alphonsus Regional Medical /ID# 216424, Boise, Idaho, United States
Rush University Medical Center /ID# 218815, Chicago, Illinois, United States
University of Kentucky Markey Cancer Center /ID# 215048, Lexington, Kentucky, United States
Norton Cancer Institute /ID# 216401, Louisville, Kentucky, United States
Tulane Medical Center - New Orleans /ID# 218166, New Orleans, Louisiana, United States
Ochsner Clinic Foundation-New Orleans /ID# 214583, New Orleans, Louisiana, United States
Tufts Medical Center /ID# 216110, Boston, Massachusetts, United States
Massachusetts General Hospital /ID# 217307, Boston, Massachusetts, United States
UMass Chan Medical School /ID# 218163, Worcester, Massachusetts, United States
Saint Louis University Cancer Center /ID# 218164, Saint Louis, Missouri, United States
Oncology Hematology Associates (OHA) - Springfield /ID# 216351, Springfield, Missouri, United States
The John Theurer Cancer /ID# 215191, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey /ID# 239708, New Brunswick, New Jersey, United States
Weill Cornell Medical College /ID# 214847, New York, New York, United States
Providence Portland Medical Ct /ID# 216231, Portland, Oregon, United States
Fox Chase Cancer Center /ID# 239372, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Ctr /ID# 214051, Pittsburgh, Pennsylvania, United States
Prisma Health Cancer Institute-Faris Road /ID# 216066, Greenville, South Carolina, United States
St Francis Cancer Center /ID# 216115, Greenville, South Carolina, United States
Gibbs Cancer Center & Research /ID# 216192, Spartanburg, South Carolina, United States
Tennessee Oncology-Nashville Centennial /ID# 218757, Nashville, Tennessee, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center /ID# 225201, Houston, Texas, United States
St George Hospital /ID# 215416, Kogarah, New South Wales, Australia
Liverpool Hospital /ID# 215415, Liverpool, New South Wales, Australia
Shoalhaven District Memorial Hospital /ID# 221973, Nowra, New South Wales, Australia
Wollongong Hospital /ID# 216071, Wollongong, New South Wales, Australia
Gold coast University Hospital /ID# 214650, SouthPort, Queensland, Australia
Toowoomba Hospital /ID# 217922, Toowoomba, Queensland, Australia
Princess Alexandra Hospital /ID# 238753, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital /ID# 238754, Adelaide, South Australia, Australia
Box Hill Hospital /ID# 217622, Box Hill, Victoria, Australia
Barwon Health /ID# 217921, Geelong, Victoria, Australia
Perth Blood Institute Ltd /ID# 217531, Nedlands, Western Australia, Australia
Tom Baker Cancer Centre /ID# 214625, Calgary, Alberta, Canada
University of Alberta Hospital - Division of Hematology /ID# 215656, Edmonton, Alberta, Canada
Juravinski Cancer Centre /ID# 214623, Hamilton, Ontario, Canada
London Health Sciences Center- University Hospital /ID# 216055, London, Ontario, Canada
Ottawa Hospital Research Institute /ID# 214627, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre /ID# 214624, Toronto, Ontario, Canada
McGill University Health Center Research Institute /ID# 215984, Montreal, Quebec, Canada
Beijing Friendship Hospital /ID# 216455, Beijing, Beijing, China
Chinese PLA General Hospital /ID# 216286, Beijing, Beijing, China
Guangdong Provincial People's Hospital /ID# 216284, Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 215565, Guangzhou, Guangdong, China
Henan Cancer Hospital /ID# 215566, Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046, Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of HUST /ID# 216456, Wuhan, Hubei, China
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283, Xi'an, Shaanxi, China
Shanghai Tongji Hospital /ID# 218800, Shanghai, Shanghai, China
West China Hospital, Sichuan University /ID# 216606, Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558, Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564, Hangzhou, Zhejiang, China
Peking University International Hospital /ID# 217439, Beijing, , China
Fakultni Nemocnice Brno /ID# 214807, Brno, , Czechia
Fakultni nemocnice Ostrava /ID# 214809, Ostrava, , Czechia
Ustav hematologie a krevni transfuze /ID# 215137, Praha, , Czechia
CHU de Nice - Hôpital Archet 1 /ID# 217368, Nice, Alpes-Maritimes, France
CHU Bordeaux - Hopital Haut Leveque /ID# 215150, Pessac, Gironde, France
CHRU Lille - Hopital Claude Huriez /ID# 217474, Lille, Hauts-de-France, France
Hopital Avicenne - APHP /ID# 215152, Bobigny, Ile-de-France, France
CHRU Tours - Hopital Bretonneau /ID# 216186, Tours CEDEX 9, Indre-et-Loire, France
CHU de Nantes - Hotel Dieu /ID# 217367, Nantes, Pays-de-la-Loire, France
Centre Hospitalier de la Cote Basque /ID# 216185, Bayonne, Pyrenees-Atlantiques, France
Centre Hospitalier du Mans /ID# 215148, Le Mans CEDEX 9, Sarthe, France
Institut Gustave Roussy /ID# 215158, Villejuif Cedex, Val-de-Marne, France
Chu Angers /Id# 215151, Angers, , France
Hopital Henri Mondor /ID# 215159, Creteil, , France
Centre Hospitalier de Versailles André Mignot /ID# 215157, Le Chesnay, , France
Universitaetsklinikum Leipzig /ID# 214440, Leipzig, Sachsen, Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173, Lübeck, Schleswig-Holstein, Germany
Klinikum Chemnitz gGmbH /ID# 216073, Chemnitz, , Germany
Universitaetsklinikum Halle (Saale) /ID# 221109, Halle (Saale), , Germany
Universitaetsklinikum Giessen und Marburg /ID# 214734, Marburg, , Germany
General Hospital of Athens Laiko /ID# 213869, Athens, Attiki, Greece
University General Hospital Attikon /ID# 214298, Athens, Attiki, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 214075, Heraklion, Kriti, Greece
General University Hospital of Alexandroupolis /ID# 213870, Alexandroupolis, , Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872, Athens, , Greece
University General Hospital of Patras /ID# 213871, RION Patras Achaia, , Greece
Debreceni Egyetem Klinikai Kozpont /ID# 214422, Debrecen, Hajdu-Bihar, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214426, Kaposvár, Somogy, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 214425, Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary
Markusovszky Egyetemi Oktatokorhaz /ID# 215644, Szombathely, Vas, Hungary
Semmelweis Egyetem /ID# 214423, Budapest, , Hungary
Tel Aviv Sourasky Medical Center /ID# 239698, Tel Aviv-Yafo, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 239700, Jerusalem, Yerushalayim, Israel
Shaare Zedek Medical Center /ID# 239699, Jerusalem, , Israel
Rabin Medical Center /ID# 239696, Petakh Tikva, , Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944, Ancona, , Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 213948, Bologna, , Italy
ASST Spedali civili di Brescia /ID# 214580, Brescia, , Italy
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802, Catania, , Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 213946, Milano, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826, Milan, , Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947, Napoli, , Italy
Azienda Ospedaliera Universitaria Federico II /ID# 214278, Napoli, , Italy
Ospedale S.Eugenio /ID# 214277, Rome, , Italy
A.O.U. Citta della Salute e della Scienza di Torino /ID# 214505, Turin, , Italy
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680, Nagoya-shi, Aichi, Japan
Aichi Cancer Center Hospital /ID# 215284, Nagoya-shi, Aichi, Japan
University of Fukui Hospital /ID# 215283, Yoshida-gun, Fukui, Japan
National Hospital Organization Kyushu Cancer Center /ID# 214841, Fukuoka-shi, Fukuoka, Japan
Kyushu University Hospital /ID# 215286, Fukuoka-shi, Fukuoka, Japan
Hokkaido University Hospital /ID# 215938, Sapporo-shi, Hokkaido, Japan
National Hospital Organization Mito Medical Center /ID# 214699, Higashi Ibaraki-gun, Ibaraki, Japan
Tohoku University Hospital /ID# 214669, Sendai-shi, Miyagi, Japan
Nagasaki University Hospital /ID# 214916, Nagasaki-shi, Nagasaki, Japan
Okayama University Hospital /ID# 214840, Okayama-shi, Okayama, Japan
Osaka Metropolitan University Hospital /ID# 215225, Osaka-shi, Osaka, Japan
Kindai University Hospital /ID# 214915, Osakasayama-shi, Osaka, Japan
Saitama Medical University International Medical Center /ID# 214823, Hidaka-shi, Saitama, Japan
NTT Medical Center Tokyo /ID# 214959, Shinagawa-ku, Tokyo, Japan
Yamagata University Hospital /ID# 214698, Yamagata-shi, Yamagata, Japan
Seoul National University Bundang Hospital /ID# 215549, Seongnam, Gyeonggido, Korea, Republic of
Pusan National University Hospital /ID# 213941, Busan, , Korea, Republic of
Seoul National University Hospital /ID# 213943, Seoul, , Korea, Republic of
Samsung Medical Center /ID# 213940, Seoul, , Korea, Republic of
Pan American Center for Oncology Trials, LLC /ID# 214953, Rio Piedras, , Puerto Rico
Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309, Nizhniy Novgorod, Nizhegorodskaya Oblast, Russian Federation
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393, St. Petersburg, Sankt-Peterburg, Russian Federation
P. Hertsen Moscow Oncology Research Institute /ID# 214312, Moscow, , Russian Federation
MMCC Kommunarka /ID# 215223, Moscow, , Russian Federation
Clinic of Immunopathology, SRIFCI /ID# 217937, Novosibirsk, , Russian Federation
Almazov National Medical Research Centre /ID# 214306, Sankt-Peterburg, , Russian Federation
Regional Clinical Hospital of Yaroslavl /ID# 214318, Yaroslavl, , Russian Federation
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715, Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Navarra /ID# 214788, Pamplona, Navarra, Spain
Hospital Santa Creu i Sant Pau /ID# 214714, Barcelona, , Spain
Hospital Universitario Reina Sofia /ID# 214786, Cordoba, , Spain
Hospital Universitario Infanta Leonor /ID# 214843, Madrid, , Spain
MD Anderson Madrid /ID# 214477, Madrid, , Spain
Hospital Universitario Ramon y Cajal /ID# 214684, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 214933, Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 214789, Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 214713, Malaga, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953, Kaohsiung, , Taiwan
China Medical University Hospital /ID# 213952, Taichung, , Taiwan
National Taiwan University Hospital /ID# 213939, Taipei City, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 213951, Taoyuan City, , Taiwan
Erciyes University Medical Fac /ID# 214240, Melikgazi, Kayseri, Turkey
Gulhane Askeri Tip Academy /ID# 214242, Ankara, , Turkey
Ankara Univ Medical Faculty /ID# 214239, Ankara, , Turkey
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 215525, Istanbul, , Turkey
Karadeniz University /ID# 214241, Trabzon, , Turkey
University Hospitals Bristol /ID# 215911, Bristol, Bristol, City Of, United Kingdom
Leicester Royal Infirmary /ID# 215924, Leicester, England, United Kingdom
Barts Health NHS Trust /ID# 215909, London, London, City Of, United Kingdom
Guys and St Thomas NHS Foundation Trust /ID# 215908, London, London, City Of, United Kingdom
Cardiff & Vale University Health Board /ID# 215906, Cardiff, Wales, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 215910, Birmingham, , United Kingdom
University College London Hospitals NHS Foundation Trust /ID# 215921, London, , United Kingdom
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
