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)

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)

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).

Study Overview

• Status: Terminated
• Conditions: Cancer; Acute Myeloid Leukemia (AML)
• Intervention / Treatment: Drug: Venetoclax; Drug: Azacitidine; Other: Best Supportive Care (BSC)

• Study Type: Interventional
• Enrollment (Actual): 465
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • The Kinghorn Cancer Centre /ID# 214660
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 215678
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Ctr /ID# 214653
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital /ID# 240931
• Brazil
  • São Paulo, Brazil, 05403-000
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 239516
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre /ID# 215042
  • São Paulo
    • Jaú, São Paulo, Brazil, 17210-070
      • Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145
    • São Paulo, São Paulo, Brazil, 01409-001
      • Hospital Nove de Julho /ID# 242359
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network_Princess Margaret Cancer Centre /ID# 215344
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591
    • Montreal, Quebec, Canada, H4A 3J1
      • Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 215253
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre /ID# 238821
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Peking University People's Hospital /ID# 215551
    • Beijing, Beijing Municipality, China, 100853
      • Chinese PLA General Hospital /ID# 216287
    • Beijing, Beijing Municipality, China, 861059
      • Aerospace Center Hospital /ID# 217018
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital /ID# 215555
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital of Southern Medical University /ID# 216333
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University /ID# 215553
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial Peoples Hospital /ID# 218666
    • Shenzhen, Guangdong, China, 518039
      • Shenzhen Second Peoples Hospital /ID# 239401
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital /ID# 215554
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University /ID# 219025
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University /ID# 218926
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University /ID# 216605
    • Xuzhou, Jiangsu, China, 221006
      • The Affiliated Hospital of Xuzhou Medical College /ID# 239098
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University /ID# 239168
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Shanghai Changhai Hospital /ID# 216334
  • Shanxi
    • Xi’an, Shanxi, China, 710038
      • Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550
• Czechia
  • Prague, Czechia, 128 00
    • Ustav hematologie a krevni transfuze /ID# 215133
  • Brno-mesto
    • Brno, Brno-mesto, Czechia, 625 00
      • Fakultní Nemocnice Brno - Jihlavská /ID# 214811
  • Hradec Kralove
    • Hradec Králové, Hradec Kralove, Czechia, 500 05
      • Fakultní nemocnice Hradec Králové - Sokolská /ID# 214814
  • Ostrava-mesto
    • Ostrava, Ostrava-mesto, Czechia, 708 52
      • Fakultni Nemocnice Ostrava /ID# 239922
• France
  • Paris, France, 75012
    • AP-HP - Hopital Saint-Antoine /ID# 216957
  • Paris, France, 75010
    • Hôpital Saint-Louis /ID# 214054
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06200
      • Duplicate_CHU de Nice - Hôpital Archet 1 /ID# 214056
  • Doubs
    • Besançon, Doubs, France, 25030
      • Duplicate_CHU de Besancon - Jean Minjoz /ID# 241171
  • Gironde
    • Pessac, Gironde, France, 33604
      • Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 214055
  • Nord
    • Lille, Nord, France, 59037
      • CHRU Lille - Hopital Claude Huriez /ID# 217916
  • Pays de la Loire Region
    • Nantes, Pays de la Loire Region, France, 44000
      • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 214060
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75013
      • Hopital Pitie Salpetriere /ID# 241072
• Germany
  • Halle, Germany, 06120
    • Universitaetsklinikum Halle (Saale) /ID# 239585
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Universitaetsklinik Heidelberg /ID# 216623
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Klinikum Augsburg /ID# 239583
    • Würzburg, Bavaria, Germany, 97080
      • Duplicate_Universitaetsklinikum Wuerzburg /ID# 215212
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Medizinische Hochschule Hannover /ID# 214243
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Universitaetsklinikum Muenster /ID# 215213
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Universitaetsklinikum Carl Gustav Carus Dresden /ID# 214244
    • Leipzig, Saxony, Germany, 04103
      • Universitaetsklinikum Leipzig /ID# 245892
• Greece
  • RION Patras Achaia, Greece, 26504
    • University General Hospital of Patras /ID# 238811
  • Attica
    • Athens, Attica, Greece, 10676
      • General Hospital of Athens Evangelismos /ID# 238810
    • Athens, Attica, Greece, 12462
      • University General Hospital Attikon /ID# 238812
• Hungary
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Debreceni Egyetem-Klinikai Kozpont /ID# 241123
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 214507
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center. /ID# 214509
  • Central District
    • Petah Tikva, Central District, Israel, 4920235
      • Schneider Children's Medical Center /ID# 224326
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 91120
      • Hadassah Medical Center-Hebrew University /ID# 218697
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 52621
      • Sheba Medical Center /ID# 239571
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 214305
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 214508
• Italy
  • Brescia, Italy, 25123
    • ASST degli Spedali Civili di Brescia /ID# 215997
  • Milano
    • Milan, Milano, Italy, 20132
      • IRCCS Ospedale San Raffaele /ID# 214311
    • Milan, Milano, Italy, 20141
      • Istituto Europeo Di Oncologia /ID# 242579
  • Piedmont
    • Turin, Piedmont, Italy, 10126
      • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 216148
  • Roma
    • Rome, Roma, Italy, 00161
      • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254964
    • Rome, Roma, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 214910
• Japan
  • Aichi-ken
    • Anjo-shi, Aichi-ken, Japan, 446-8602
      • Anjou Kousei Hospital /ID# 215857
    • Nagoya, Aichi-ken, Japan, 453-8511
      • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679
  • Fukui
    • Yoshida-gun, Fukui, Japan, 910-1104
      • University of Fukui Hospital /ID# 253383
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital /ID# 215285
  • Fukushima
    • Fukushima, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital /ID# 252293
  • Hiroshima
    • Hiroshima, Hiroshima, Japan, 730-8619
      • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 217522
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital /ID# 215937
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0047
      • Kobe City Medical Center General Hospital /ID# 215388
    • Nishinomiya-shi, Hyōgo, Japan, 663-8501
      • Hyogo Medical University Hospital /ID# 215389
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8641
      • Kanazawa University Hospital /ID# 242955
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan, 890-0064
      • Imamura General Hospital /ID# 215688
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Tokai University Hospital /ID# 250086
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa Cancer Center /ID# 215029
  • Kyoto
    • Kyoto, Kyoto, Japan, 606-8507
      • Kyoto University Hospital /ID# 243209
  • Miyagi
    • Sendai, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 214670
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 700-8558
      • Okayama University Hospital /ID# 214842
  • Osaka
    • Osaka, Osaka, Japan, 545-8586
      • Osaka Metropolitan University Hospital /ID# 215227
    • Sakai-shi, Osaka, Japan, 590-0197
      • Kindai University Hospital /ID# 214917
  • Saitama
    • Saitama-shi, Saitama, Japan, 330-8503
      • Jichi Medical University Saitama Medical Center /ID# 216092
  • Tochigi
    • Shimotsuke-shi, Tochigi, Japan, 329-0498
      • Jichi Medical University Hospital /ID# 216091
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8677
      • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital /ID# 242639
    • Minato-ku, Tokyo, Japan, 105-8470
      • Toranomon Hospital /ID# 215311
    • Setagaya-ku, Tokyo, Japan, 157-8535
      • Duplicate_National Center for Child Health and Development /ID# 242479
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital /ID# 243549
  • Yamagata
    • Yamagata, Yamagata, Japan, 990-9585
      • Yamagata University Hospital /ID# 253304
• South Korea
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital /ID# 214891
    • Seoul, Seoul Teugbyeolsi, South Korea, 05505
      • Asan Medical Center /ID# 214893
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Samsung Medical Center /ID# 239087
    • Seoul, Seoul Teugbyeolsi, South Korea, 06591
      • The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214892
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 215108
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 240397
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 215107
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal /ID# 218102
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 218103
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 215463
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia /ID# 215106
• Switzerland
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4031
      • Duplicate_Universitätsspital Basel /ID# 215892
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • University Hospital Zurich /ID# 215891
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 215198
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital /ID# 239288
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hosp /ID# 239289
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 215319
  • Taipei
    • Taipei City, Taipei, Taiwan, 100
      • National Taiwan University Hospital /ID# 215245
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust /ID# 215120
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust /ID# 215124
  • Newcastle upon Tyne, United Kingdom, NE3 3HD
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359
  • England
    • London, England, United Kingdom, W12 0HS
      • Hammersmith Hospital /ID# 215665
  • Glasgow City
    • Glasgow, Glasgow City, United Kingdom, G12 0YN
      • Gartnavel General Hospital /ID# 215663
  • Greater London
    • London, Greater London, United Kingdom, NW1 2BU
      • University College London Hospital /ID# 215662
    • London, Greater London, United Kingdom, SE5 9RS
      • Kings College Hospital NHS Foundation Trust /ID# 215338
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258-4547
      • Arizona Oncology - Scottsdale - Cancer Transplant Institute /ID# 239711
    • Tucson, Arizona, United States, 85724
      • University of Arizona Cancer Center - Tucson /ID# 242507
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences /ID# 239804
  • California
    • Duarte, California, United States, 91010
      • City of Hope /ID# 213681
  • Colorado
    • Aurora, Colorado, United States, 80045-2517
      • UCHSC Anschultz Cancer Pavilion /ID# 215618
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute /ID# 215980
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Hospital Jacksonville /ID# 239710
    • Orlando, Florida, United States, 32804-5505
      • AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985
  • Illinois
    • Chicago, Illinois, United States, 60637-1443
      • The University of Chicago Medical Center /ID# 215616
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 215840
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Ctr /ID# 215617
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indiana Blood & Marrow Transpl /ID# 215842
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 213834
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland, Baltimore /ID# 213855
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital /ID# 215765
  • Michigan
    • Detroit, Michigan, United States, 48201-2013
      • Karmanos Cancer Institute - Dresner Clinic /ID# 214581
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center /ID# 239492
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 214685
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4500
      • University of Mississippi Medical Center /ID# 239343
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • The John Theurer Cancer /ID# 215251
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute /ID# 217857
    • New York, New York, United States, 10032-3729
      • Columbia University Medical Center /ID# 240875
    • New York, New York, United States, 10065-6007
      • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680
    • New York, New York, United States, 10065
      • Weill Cornell Medical College /ID# 214887
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center - Moses Campus /ID# 241669
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina /ID# 215814
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Medical Center /ID# 239210
  • Ohio
    • Cincinnati, Ohio, United States, 45267-2800
      • UC Health - Cincinnati /ID# 239263
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center /ID# 239260
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-5418
      • University of Oklahoma, Stephenson Cancer Center /ID# 215611
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University /ID# 215874
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-2360
      • Penn State Hershey Medical Ctr /ID# 217120
    • Philadelphia, Pennsylvania, United States, 19104-4319
      • Children's Hospital of Philadelphia - Main /ID# 215410
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 214518
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Ctr /ID# 213715
    • Pittsburgh, Pennsylvania, United States, 15212
      • Duplicate_Allegheny General Hospital /ID# 216756
  • Tennessee
    • Nashville, Tennessee, United States, 37203-1551
      • TriStar Centennial Medical Center /ID# 218750
  • Texas
    • Dallas, Texas, United States, 75230
      • Texas Oncology - Medical City Dallas /ID# 216720
    • Dallas, Texas, United States, 75246-2003
      • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735
    • San Antonio, Texas, United States, 78229
      • Texas Transplant Institute /ID# 214691
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Medical Center Main Hospital /ID# 239203
  • Washington
    • Seattle, Washington, United States, 98109-1024
      • Fred Hutchinson Cancer Research Center /ID# 214436
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-0001
      • Univ of Wisconsin Hosp/Clinics /ID# 216096

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 60 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care; 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)	Drug: Venetoclax; Tablet; Oral; Other Names: ABT-199; GDC-0199; VENCLEXTA; Drug: Azacitidine; Subcutaneous (SC) or intravenous (IV) injection; Other: Best Supportive Care (BSC); BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
Experimental: Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC; 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).	Drug: Venetoclax; Tablet; Oral; Other Names: ABT-199; GDC-0199; VENCLEXTA; Drug: Azacitidine; Subcutaneous (SC) or intravenous (IV) injection; Other: Best Supportive Care (BSC); BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
Experimental: Part 2: Arm B - Best Supportive Care (BSC); Participants will receive treatment as prescribed by their physician according to the BSC for up to 24 cycles (1 cycle = 28 days)	Other: Best Supportive Care (BSC); BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1)	DLTs were any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax and AZA as described in the protocol and evaluated by the Investigator and the sponsor.	Up to 28 days
Overall Survival (OS) (Part 2)	OS was defined as the time from the date of randomization to the date of death from any cause.	Up to approximately 41 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphologic Relapse-Free Survival (RFS) (Part 2)	Morphologic relapse from AML was defined as bone marrow blasts of >= 5% or reappearance of blasts in the peripheral blood not attributable to any other cause (e.g., bone marrow regeneration) in at least 2 peripheral blood samples at least one week apart or development of extramedullary disease after achieving a complete remission (CR) or complete remission with incomplete count recovery (CRi); or the date of death from any cause, whichever comes first as determined by the investigator.	Up to approximately 41 months
Composite Relapse-Free Survival (RFS) (Part 2)	Composite RFS was defined as the time from randomization from either morphologic relapse from AML, or non-morphologic relapse from AML, whichever comes first. Non-morphologic relapse from AML was defined as increase in disease burden determined by standard methods with reappearance or acquisition of new findings with or without change in anti-leukemic treatment per investigator decision due to cytogenetic abnormalities or change in molecular marker or measurable residual disease by multiparameter flow with sensitivity to at least 10^-3; or the date of death from any cause, whichever came first as determined by the investigator.	Up to approximately 41 months
Graft-versus-Host Disease (GvHD)-Free, Relapse Free Survival (GRFS) (Part 2)	GRFS was defined as the time from the date of randomization to occurrence of disease relapse or incidence of GvHD or death from any cause.	Up to approximately 41 months
Rate of Participants Without Higher Grade of GvHD (Part 2)	Rate of Participants without higher grade of GvHD was defined as the percentage of participants without grade 2 or higher for acute graft-versus-host disease (aGvHD) and moderate/severe for chronic graft-versus-host disease (cGvHD) assessed by investigator at 90 days after randomization.	90 days after randomization
Change From Baseline in Physical Functioning Subscore as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) (Part 2)	The EORTC QLQ-C30 is a 30-item participant self-report questionnaire composed of both multi-item and single scales. The physical functioning score, reported here, ranged from 0 to 100, with a higher score indicating a better level of functioning. Positive changes from baseline indicate improvement.	Baseline, Month 6
Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form (SF) 7a Score (Part 2)	PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.	Baseline, Month 6
Percentage of Participants With Measurable Residual Disease (MRD) Conversion in Participants With MRD >= 10^-3 at Baseline (Part 2)	MRD conversion rate was defined as the percentage of participants who convert to MRD < 10^-3 after initiation of treatment. The population for MRD analysis included participants whose bone marrow was MRD positive (>=10^-3, as determined by central flow cytometry) at baseline prior to randomization.	Up to approximately 41 months
Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2)	Time to deterioration was defined as number of days from randomization to either deterioration of >= 5 points based on the EORTC QLQ-C30 version 3 or death due to any cause. The GHS/QoL scale includes 2 questions in which participants were asked to rate their overall health and overall quality of life during the past week on a scale from 1 (very poor) to 7 (excellent). The 2 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL.	Up to approximately 41 months
Change From Baseline in European Quality-of-Life-5 Dimensional-5-Level (EQ-5D-5L) Score	The EQ-5D-5L is a generic preference instrument that has been validated in numerous populations and has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each of which are rated on five levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems) with higher scores representing higher symptom burden. A negative change from baseline indicates improvement in health status.	Baseline, Month 6

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): September 23, 2025
• Study Completion (Actual): September 23, 2025

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Venetoclax; Azacitidine; Acute Myeloid Leukemia (AML); Stem Cell Transplantation (SCT); Best Support Care (BSC)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Neoplasms; Leukemia, Myeloid, Acute; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Aza Compounds; Nucleosides; Ribonucleosides; Azacitidine; venetoclax
• Other Study ID Numbers: M19-063; 2023-507222-17-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No