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: Active, not recruiting
• 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

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

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
      • Alfred Health /ID# 240931
• Brazil
  • Sao Paulo, Brazil, 05403-000
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 239516
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre /ID# 215042
  • Sao Paulo
    • Jaú, Sao Paulo, Brazil, 17210-070
      • Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145
    • São Paulo, Sao 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
      • 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
      • Royal Victoria Hospital / McGill University Health Centre /ID# 215253
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre /ID# 238821
• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital /ID# 215551
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital /ID# 216287
    • Beijing, Beijing, China, 861059
      • Aerospace Center Hospital /ID# 217018
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital /ID# 215555
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital /ID# 218666
    • Guangzhou, Guangdong, China, 510280
      • Zhujiang Hospital of Southern Medical University /ID# 216333
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University /ID# 215553
    • Shenzhen, Guangdong, China, 518025
      • Shenzhen Second People's 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, 221000
      • The Affiliated Hospital of Xuzhou Medical University /ID# 239098
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University /ID# 239168
  • Shanghai
    • Shanghai, Shanghai, 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
    • Tianjin, Tianjin, 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
  • Brno, Czechia, 625 00
    • Fakultni Nemocnice Brno /ID# 214811
  • Hradec Kralove, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove /ID# 214814
  • Ostrava, Czechia, 708 52
    • Fakultni Nemocnice Ostrava /ID# 239922
  • Praha, Czechia, 128 00
    • Ustav hematologie a krevni transfuze /ID# 215133
• France
  • Paris, France, 75010
    • AP-HP - Hopital Saint-Louis /ID# 214054
  • Paris, France, 75012
    • AP-HP - Hopital Saint-Antoine /ID# 216957
  • Paris, France, 75013
    • Hopital Pitie Salpetriere /ID# 241072
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06200
      • CHU de Nice - Hôpital Archet 1 /ID# 214056
  • Doubs
    • Besancon, Doubs, France, 25030
      • CHU de Besancon - Jean Minjoz /ID# 241171
  • Gironde
    • Pessac, Gironde, France, 33604
      • CHU Bordeaux - Hopital Haut Leveque /ID# 214055
  • Nord
    • Lille, Nord, France, 59037
      • CHRU Lille - Hopital Claude Huriez /ID# 217916
  • Pays-de-la-Loire
    • Nantes, Pays-de-la-Loire, France, 44000
      • CHU de Nantes, Hotel Dieu -HME /ID# 214060
• Germany
  • Augsburg, Germany, 86156
    • Klinikum Augsburg /ID# 239583
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214244
  • Halle (Saale), Germany, 06120
    • Universitaetsklinikum Halle (Saale) /ID# 239585
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover /ID# 214243
  • Wuerzburg, Germany, 97080
    • Universitaetsklinikum Wuerzburg /ID# 215212
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • Universitaetsklinik Heidelberg /ID# 216623
  • Nordrhein-Westfalen
    • Muenster, Nordrhein-Westfalen, Germany, 48149
      • Universitaetsklinikum Muenster /ID# 215213
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Universitaetsklinikum Leipzig /ID# 245892
• Greece
  • RION Patras Achaia, Greece, 26504
    • University General Hospital of Patras /ID# 238811
  • Attiki
    • Athens, Attiki, Greece, 10676
      • General Hospital of Athens Evangelismos /ID# 238810
    • Athens, Attiki, Greece, 12462
      • University General Hospital Attikon /ID# 238812
• Hungary
  • Hajdu-Bihar
    • Debrecen, Hajdu-Bihar, Hungary, 4032
      • Debreceni Egyetem Klinikai Kozpont /ID# 241123
• Israel
  • H_efa
    • Haifa, H_efa, Israel, 3109601
      • Rambam Health Care Campus /ID# 214507
    • Haifa, H_efa, Israel, 4941492
      • Rabin Medical Center /ID# 214509
  • HaMerkaz
    • Petah Tikva, HaMerkaz, Israel, 4920235
      • Schneider Children's Medical Center /ID# 224326
  • 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
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 91120
      • Hadassah Medical Center-Hebrew University /ID# 218697
• Italy
  • Brescia, Italy, 25123
    • ASST Spedali civili di Brescia /ID# 215997
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910
  • Milano
    • Milan, Milano, Italy, 20132
      • Ospedale San Raffaele IRCCS /ID# 214311
    • Milan, Milano, Italy, 20141
      • IEO -Istituto Europeo di Oncologia /ID# 242579
  • Roma
    • Rome, Roma, Italy, 00161
      • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254964
  • Torino
    • Turin, Torino, Italy, 10126
      • A.O.U. Citta della Salute e della Scienza di Torino /ID# 216148
• Japan
  • Aichi
    • Anjo-shi, Aichi, Japan, 446-8602
      • Anjou Kousei Hospital /ID# 215857
    • Nagoya-shi, Aichi, Japan, 453-8511
      • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679
  • Fukui
    • Yoshida-gun, Fukui, Japan, 910-1193
      • University of Fukui Hospital /ID# 253383
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 812-8582
      • Kyushu University Hospital /ID# 215285
  • Fukushima
    • Fukushima-shi, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital /ID# 252293
  • Hiroshima
    • Hiroshima-shi, Hiroshima, Japan, 730-8619
      • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 217522
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital /ID# 215937
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0047
      • Kobe City Medical Center General Hospital /ID# 215388
    • Nishinomiya-shi, Hyogo, Japan, 663-8501
      • Hyogo Medical University Hospital /ID# 215389
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital /ID# 242955
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 890-0064
      • Imamura General Hospital /ID# 215688
  • Kanagawa
    • Isehara-shi, Kanagawa, Japan, 259-1193
      • Tokai University Hospital /ID# 250086
    • Yokohama-shi, Kanagawa, Japan, 241-8515
      • Kanagawa Cancer Center /ID# 215029
  • Kyoto
    • Kyoto-shi, Kyoto, Japan, 606-8507
      • Kyoto University Hospital /ID# 243209
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 214670
  • Okayama
    • Okayama-shi, Okayama, Japan, 700-8558
      • Okayama University Hospital /ID# 214842
  • Osaka
    • Osaka-shi, Osaka, Japan, 545-8586
      • Osaka Metropolitan University Hospital /ID# 215227
    • Osakasayama-shi, Osaka, Japan, 589-8511
      • 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
      • National Center for Child Health and Development /ID# 242479
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital /ID# 243549
  • Yamagata
    • Yamagata-shi, Yamagata, Japan, 990-9585
      • Yamagata University Hospital /ID# 253304
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 214891
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center /ID# 214893
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center /ID# 239087
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's 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
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 215463
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia /ID# 215106
• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Universitätsspital Basel /ID# 215892
  • Zuerich
    • Zurich, Zuerich, Switzerland, 8091
      • Universitatsspital Zurich /ID# 215891
• Taiwan
  • Kaohsiung, 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
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital /ID# 215245
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 215319
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Foundation Trust /ID# 215120
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHS Foundation Trust /ID# 215662
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trust /ID# 215338
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust /ID# 215124
  • London, United Kingdom, W2 1NY
    • Imperial College Healthcare NHS Trust /ID# 215665
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 0XH
      • NHS Greater Glasgow and Clyde /ID# 215663
• 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 /ID# 239710
    • Orlando, Florida, United States, 32804-5505
      • AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840
    • Chicago, Illinois, United States, 60637-1443
      • The University of Chicago Medical Center /ID# 215616
    • 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
      • Ochsner Clinic Foundation-New Orleans /ID# 213834
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Med Ctr /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
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center - Moses Campus /ID# 241669
    • Buffalo, New York, United States, 14263
      • Roswell Park Comprehensive Cancer Center /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
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina /ID# 215814
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Univ HS /ID# 239210
  • Ohio
    • Cincinnati, Ohio, United States, 45267-2800
      • UC Health - Cincinnati /ID# 239263
    • Cleveland, Ohio, United States, 44106-1716
      • University Hospitals - Seidman Cancer Center /ID# 239260
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-5418
      • University of Oklahoma, Stephenson Cancer Center /ID# 215611
  • Oregon
    • Portland, Oregon, United States, 97239-3011
      • Oregon Health & 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, 19104-5127
      • Perelman Center for Advanced Medicine - /ID# 214518
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital /ID# 216756
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Ctr /ID# 213715
  • 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
Overall Survival (OS) (Part 2)	OS is defined as the number of days from the date of randomization to the date of death from any cause.	Up to 45 months after the first participant is randomized
Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1)	DLTs are 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 the first treatment cycle (28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2)	Time to deterioration defined as number of days from randomization to either deterioration of >= 5 points based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3 or death due to any cause.	Up to 39 months after the first participant is randomized
Change From Randomization in Fatigue in Adult Participants (Part 2)	Fatigue is measured as Patient Reported Outcome (PRO) using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a.	Up to 39 months after the first participant is randomized
Change in Patient Reported Signs, Symptoms and Impact of Acute Myeloid Leukemia (AML) as Measured by the European Quality-of-Life-5 Dimensional-5-Level (EQ-5D-5L)	The EQ-5D-5L is a generic preference instrument that has been validated in numerous population and has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a 5-point scale: with higher scores representing better functioning/quality of life and greater symptom burden.	Up to 39 months after the first participant is randomized
Morphologic Relapse-Free Survival (RFS) (Part 2)	Morphologic relapse from AML 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 Independent Review Committee (IRC).	Up to 39 months after the first participant is randomized
Composite Relapse-Free Survival (RFS) (Part 2)	Morphologic relapse from AML, non-morphologic relapse from AML, which is 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 comes first as determined by IRC.	Up to 39 months after the first participant is randomized
Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2)	GRFS is defined as number of days from the date of randomization to occurrence of disease relapse OR incidence of GvHD OR death from any cause.	Up to 39 months after the first participant is randomized
Graft-versus-Host Disease (GvHD) Rate (Part 2)	GvHD rate is defined as grade 2 or higher for acute graft-versus-host disease (aGvHD) and moderate/severe for chronic graft-versus-host disease (cGvHD) assessed by investigator.	Up to 39 months after the first participant is randomized
Change from Baseline in Physical Functioning 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 patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participantts rate items on a 4-point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much).	Up to 39 months after the first participant is randomized
Measurable Residual Disease (MRD) Response Rate in Participants With MRD >= 10^-3 at Randomization (Part 2)	MRD conversion rate is defined as percentage of participants who convert to MRD < 10^-3 after initiation of treatment.	Up to 39 months after the first participant is randomized

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 (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

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 (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

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; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Venetoclax; Azacitidine
• Other Study ID Numbers: M19-063; 2019-002621-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on 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