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) (VIALE-T)
Acute Myeloid Leukemia (AML), Cancer
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring Acute Myeloid Leukemia (AML), Venetoclax, Azacitidine, Stem Cell Transplantation (SCT), Best Support Care (BSC), Cancer
Eligibility Criteria
Inclusion Criteria:
- Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2.
- Participant must be diagnosed with Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 45 days.
- Blast percentage in bone marrow before transplant must be < 10%.
- Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must be < 5% after transplant.
- Participant meet adequate renal, hepatic and hematologic criteria as described in the protocol.
- Participants >= 17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and participants between 12 to 16 years old must have a Lansky Play Performance Scale score > 40.
Exclusion Criteria:
- History of disease progression during prior treatment with venetoclax.
- History of any other malignancy within 2 years prior to study entry, except for: Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; Myelodysplastic Syndrome, Myeloproliferative neoplasm (only allowed if it transformed to AML and AML should be the indication for marrow transplantation).
- Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.
Sites / Locations
- Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 239711Recruiting
- University of Arizona Cancer Center - Tucson /ID# 242507Recruiting
- University of Arkansas for Medical Sciences /ID# 239804Recruiting
- City of Hope /ID# 213681Recruiting
- UCHSC Anschultz Cancer Pavilion /ID# 215618Recruiting
- Colorado Blood Cancer Institute /ID# 215980Recruiting
- Mayo Clinic /ID# 239710Recruiting
- AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985Recruiting
- Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840Recruiting
- The University of Chicago Medical Center /ID# 215616Recruiting
- Loyola University Medical Ctr /ID# 215617Recruiting
- Indiana Blood & Marrow Transpl /ID# 215842Recruiting
- Ochsner Clinic Foundation-New Orleans /ID# 213834Recruiting
- University of Maryland Med Ctr /ID# 213855Recruiting
- Massachusetts General Hospital /ID# 215765Recruiting
- Karmanos Cancer Institute - Dresner Clinic /ID# 214581Recruiting
- Masonic Cancer Center /ID# 239492Recruiting
- Mayo Clinic - Rochester /ID# 214685Recruiting
- University of Mississippi Medical Center /ID# 239343Recruiting
- The John Theurer Cancer /ID# 215251Recruiting
- Montefiore Medical Center - Moses Campus /ID# 241669Recruiting
- Roswell Park Comprehensive Cancer Center /ID# 217857Recruiting
- Columbia University Medical Center /ID# 240875Recruiting
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680Recruiting
- Weill Cornell Medical College /ID# 214887
- University of North Carolina /ID# 215814Recruiting
- Wake Forest Univ HS /ID# 239210Recruiting
- UC Health - Cincinnati /ID# 239263Recruiting
- University Hospitals - Seidman Cancer Center /ID# 239260Recruiting
- University of Oklahoma, Stephenson Cancer Center /ID# 215611Recruiting
- Oregon Health & Science University /ID# 215874Recruiting
- Penn State Hershey Medical Ctr /ID# 217120Recruiting
- Children's Hospital of Philadelphia - Main /ID# 215410Recruiting
- Perelman Center for Advanced Medicine - /ID# 214518Recruiting
- Allegheny General Hospital /ID# 216756Recruiting
- UPMC Hillman Cancer Ctr /ID# 213715Recruiting
- TriStar Centennial Medical Center /ID# 218750Recruiting
- Texas Oncology - Medical City Dallas /ID# 216720Recruiting
- Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735Recruiting
- Texas Transplant Institute /ID# 214691
- Virginia Commonwealth University Medical Center Main Hospital /ID# 239203Recruiting
- Fred Hutchinson Cancer Research Center /ID# 214436Recruiting
- Univ of Wisconsin Hosp/Clinics /ID# 216096Recruiting
- The Kinghorn Cancer Centre /ID# 214660Recruiting
- Royal Adelaide Hospital /ID# 215678Recruiting
- Peter MacCallum Cancer Ctr /ID# 214653Recruiting
- Alfred Health /ID# 240931Recruiting
- Hospital de Clinicas de Porto Alegre /ID# 215042Recruiting
- Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145Recruiting
- Hospital Nove de Julho /ID# 242359Recruiting
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 239516Recruiting
- Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363Recruiting
- Princess Margaret Cancer Centre /ID# 215344Recruiting
- CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591Recruiting
- Royal Victoria Hospital / McGill University Health Centre /ID# 215253Recruiting
- Saskatoon Cancer Centre /ID# 238821Recruiting
- Peking University People's Hospital /ID# 215551Recruiting
- Chinese PLA General Hospital /ID# 216287Recruiting
- Aerospace Center Hospital /ID# 217018Recruiting
- Fujian Medical University Union Hospital /ID# 215555Recruiting
- Guangdong Provincial People's Hospital /ID# 218666Recruiting
- Zhujiang Hospital of Southern Medical University /ID# 216333Recruiting
- Nanfang Hospital of Southern Medical University /ID# 215553Recruiting
- Shenzhen Second People's Hospital /ID# 239401Recruiting
- Henan Cancer Hospital /ID# 215554Recruiting
- Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552Recruiting
- Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373Recruiting
- Xiangya Hospital Central South University /ID# 219025Recruiting
- Zhongda Hospital Southeast University /ID# 218926Recruiting
- The First Affiliated Hospital of Soochow University /ID# 216605Recruiting
- The Affiliated Hospital of Xuzhou Medical University /ID# 239098Recruiting
- The First Affiliated Hospital of Nanchang University /ID# 239168Recruiting
- Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282Recruiting
- Shanghai Changhai Hospital /ID# 216334Recruiting
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546Recruiting
- The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550Recruiting
- Fakultni Nemocnice Brno /ID# 214811Recruiting
- Fakultni nemocnice Hradec Kralove /ID# 214814Recruiting
- Fakultni nemocnice Ostrava /ID# 239922Recruiting
- Ustav hematologie a krevni transfuze /ID# 215133Recruiting
- CHU de Nice - Hôpital Archet 1 /ID# 214056Recruiting
- CHU de Besancon - Jean Minjoz /ID# 241171Recruiting
- CHU Bordeaux - Hopital Haut Leveque /ID# 214055Recruiting
- CHRU Lille - Hopital Claude Huriez /ID# 217916Recruiting
- CHU de Nantes, Hotel Dieu -HME /ID# 214060Recruiting
- AP-HP - Hopital Saint-Louis /ID# 214054Recruiting
- AP-HP - Hopital Saint-Antoine /ID# 216957Recruiting
- Hopital Pitie Salpetriere /ID# 241072Recruiting
- Universitaetsklinik Heidelberg /ID# 216623Recruiting
- Universitaetsklinikum Muenster /ID# 215213Recruiting
- Universitaetsklinikum Leipzig /ID# 245892Recruiting
- Klinikum Augsburg /ID# 239583Recruiting
- Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214244Recruiting
- Universitaetsklinikum Halle (Saale) /ID# 239585Recruiting
- Medizinische Hochschule Hannover /ID# 214243Recruiting
- Universitaetsklinikum Wuerzburg /ID# 215212
- General Hospital of Athens Evangelismos /ID# 238810Recruiting
- University General Hospital Attikon /ID# 238812Recruiting
- University General Hospital of Patras /ID# 238811Recruiting
- Debreceni Egyetem Klinikai Kozpont /ID# 241123Recruiting
- The Chaim Sheba Medical Center /ID# 214305Recruiting
- Tel Aviv Sourasky Medical Center /ID# 214508Recruiting
- Hadassah Medical Center-Hebrew University /ID# 218697Recruiting
- Rambam Health Care Campus /ID# 214507Recruiting
- Schneider Children's Medical Center /ID# 224326Recruiting
- Rabin Medical Center /ID# 214509Recruiting
- Sheba Medical Center /ID# 239571Recruiting
- Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254964Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910Recruiting
- Ospedale San Raffaele IRCCS /ID# 214311Recruiting
- IEO -Istituto Europeo di Oncologia /ID# 242579Recruiting
- ASST Spedali civili di Brescia /ID# 215997Recruiting
- A.O.U. Citta della Salute e della Scienza di Torino /ID# 216148Recruiting
- Anjou Kousei Hospital /ID# 215857Recruiting
- Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679Recruiting
- University of Fukui Hospital /ID# 253383Recruiting
- Kyushu University Hospital /ID# 215285Recruiting
- Fukushima Medical University Hospital /ID# 252293Recruiting
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 217522Recruiting
- Hokkaido University Hospital /ID# 215937Recruiting
- Kobe City Medical Center General Hospital /ID# 215388Recruiting
- Hyogo Medical University Hospital /ID# 215389Recruiting
- Kanazawa University Hospital /ID# 242955Recruiting
- Imamura General Hospital /ID# 215688Recruiting
- Tokai University Hospital /ID# 250086Recruiting
- Kanagawa Cancer Center /ID# 215029Recruiting
- Kyoto University Hospital /ID# 243209Recruiting
- Tohoku University Hospital /ID# 214670Recruiting
- Okayama University Hospital /ID# 214842Recruiting
- Osaka Metropolitan University Hospital /ID# 215227Recruiting
- Kindai University Hospital /ID# 214917Recruiting
- Jichi Medical University Saitama Medical Center /ID# 216092Recruiting
- Jichi Medical University Hospital /ID# 216091Recruiting
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939
- National Cancer Center Hospital /ID# 242639Recruiting
- Toranomon Hospital /ID# 215311Recruiting
- National Center for Child Health and Development /ID# 242479Recruiting
- Keio University Hospital /ID# 243549Recruiting
- Yamagata University Hospital /ID# 253304Recruiting
- Seoul National University Hospital /ID# 214891Recruiting
- Asan Medical Center /ID# 214893Recruiting
- Samsung Medical Center /ID# 239087Recruiting
- The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214892Recruiting
- Hospital Clinic de Barcelona /ID# 215108Recruiting
- Hospital Santa Creu i Sant Pau /ID# 240397Recruiting
- Hospital General Universitario Gregorio Maranon /ID# 215107Recruiting
- Hospital Universitario Ramon y Cajal /ID# 218102Recruiting
- Hospital Universitario La Paz /ID# 218103Recruiting
- Hospital Universitario Virgen del Rocio /ID# 215463Recruiting
- Hospital Clinico Universitario de Valencia /ID# 215106Recruiting
- Universitätsspital Basel /ID# 215892Recruiting
- Universitatsspital Zurich /ID# 215891Recruiting
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197Recruiting
- China Medical University Hospital /ID# 215198Recruiting
- Taichung Veterans General Hospital /ID# 239288Recruiting
- National Taiwan University Hospital /ID# 215245Recruiting
- Taipei Veterans General Hosp /ID# 239289Recruiting
- Linkou Chang Gung Memorial Hospital /ID# 215319Recruiting
- NHS Greater Glasgow and Clyde /ID# 215663Recruiting
- University Hospitals Birmingham NHS Foundation Trust /ID# 215120Recruiting
- University College London Hospitals NHS Foundation Trust /ID# 215662Recruiting
- King's College Hospital NHS Foundation Trust /ID# 215338Recruiting
- The Royal Marsden NHS Foundation Trust /ID# 215124Recruiting
- Imperial College Healthcare NHS Trust /ID# 215665Recruiting
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care
Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC
Part 2: Arm B - Best Supportive Care (BSC)
Participants will be administered various doses and dose regiments of venetoclax and AZA. Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days)
Participants will be administered with venetoclax and AZA at a dose level determined in Part 1 in addition to best supportive care (when required). Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days).
Participants will receive treatment as prescribed by their physician according to the BSC for up to 24 cycles (1 cycle = 28 days)