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)
NCT ID: NCT04161885
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
465 participants
INTERVENTIONAL
2020-02-26
2025-09-23
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
Venetoclax
Tablet; Oral
Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
Best Supportive Care (BSC)
BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
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).
Venetoclax
Tablet; Oral
Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
Best Supportive Care (BSC)
BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
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)
Best Supportive Care (BSC)
BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
Interventions
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Venetoclax
Tablet; Oral
Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
Best Supportive Care (BSC)
BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
12 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 213834
New Orleans, Louisiana, United States
University of Maryland, Baltimore /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
Roswell Park Cancer Institute /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
Montefiore Medical Center - Moses Campus /ID# 241669
The Bronx, 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 and 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
Duplicate_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
The Alfred Hospital /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, São Paulo, Brazil
Hospital Nove de Julho /ID# 242359
São Paulo, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 239516
São Paulo, , Brazil
Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363
Vancouver, British Columbia, Canada
University Health Network_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 Municipality, China
Chinese PLA General Hospital /ID# 216287
Beijing, Beijing Municipality, China
Aerospace Center Hospital /ID# 217018
Beijing, Beijing Municipality, 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 College /ID# 239098
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 239168
Nanchang, Jiangxi, China
Shanghai Changhai Hospital /ID# 216334
Shanghai, Shanghai Municipality, 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 Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550
Hangzhou, Zhejiang, China
Fakultní Nemocnice Brno - Jihlavská /ID# 214811
Brno, Brno-mesto, Czechia
Fakultní nemocnice Hradec Králové - Sokolská /ID# 214814
Hradec Králové, Hradec Kralove, Czechia
Fakultni Nemocnice Ostrava /ID# 239922
Ostrava, Ostrava-mesto, Czechia
Ustav hematologie a krevni transfuze /ID# 215133
Prague, , Czechia
Duplicate_CHU de Nice - Hôpital Archet 1 /ID# 214056
Nice, Alpes-Maritimes, France
CHU de Besancon - Jean Minjoz /ID# 241171
Besançon, Doubs, France
Duplicate_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 Region, France
Hôpital Saint-Louis /ID# 214054
Paris, , France
AP-HP - Hopital Saint-Antoine /ID# 216957
Paris, , France
Hopital Pitie Salpetriere /ID# 241072
Paris, Île-de-France Region, France
Universitaetsklinik Heidelberg /ID# 216623
Heidelberg, Baden-Wurttemberg, Germany
Klinikum Augsburg /ID# 239583
Augsburg, Bavaria, Germany
Universitaetsklinikum Wuerzburg /ID# 215212
Würzburg, Bavaria, Germany
Universitaetsklinikum Muenster /ID# 215213
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden /ID# 214244
Dresden, Saxony, Germany
Universitaetsklinikum Leipzig /ID# 245892
Leipzig, Saxony, Germany
Universitaetsklinikum Halle (Saale) /ID# 239585
Halle, , Germany
Medizinische Hochschule Hannover /ID# 214243
Hanover, , Germany
General Hospital of Athens Evangelismos /ID# 238810
Athens, Attica, Greece
University General Hospital Attikon /ID# 238812
Athens, Attica, Greece
University General Hospital of Patras /ID# 238811
RION Patras Achaia, , Greece
Debreceni Egyetem-Klinikai Kozpont /ID# 241123
Debrecen, Hajdú-Bihar, Hungary
Schneider Children's Medical Center /ID# 224326
Petah Tikva, Central District, Israel
Rambam Health Care Campus /ID# 214507
Haifa, H_efa, Israel
Hadassah Medical Center-Hebrew University /ID# 218697
Jerusalem, Jerusalem, 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
Rabin Medical Center /ID# 214509
Petah Tikva, , Israel
IRCCS Ospedale San Raffaele /ID# 214311
Milan, Milano, Italy
Istituto Europeo Di Oncologia /ID# 242579
Milan, Milano, Italy
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 216148
Turin, Piedmont, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254964
Rome, Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910
Rome, Roma, Italy
ASST degli Spedali Civili di Brescia /ID# 215997
Brescia, , Italy
Anjou Kousei Hospital /ID# 215857
Anjo-shi, Aichi-ken, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679
Nagoya, Aichi-ken, Japan
University of Fukui Hospital /ID# 253383
Yoshida-gun, Fukui, Japan
Kyushu University Hospital /ID# 215285
Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital /ID# 252293
Fukushima, Fukushima, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 217522
Hiroshima, Hiroshima, Japan
Hokkaido University Hospital /ID# 215937
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital /ID# 215388
Kobe, Hyōgo, Japan
Hyogo Medical University Hospital /ID# 215389
Nishinomiya-shi, Hyōgo, Japan
Kanazawa University Hospital /ID# 242955
Kanazawa, Ishikawa-ken, Japan
Imamura General Hospital /ID# 215688
Kagoshima, Kagoshima-ken, Japan
Tokai University Hospital /ID# 250086
Isehara, Kanagawa, Japan
Kanagawa Cancer Center /ID# 215029
Yokohama, Kanagawa, Japan
Kyoto University Hospital /ID# 243209
Kyoto, Kyoto, Japan
Tohoku University Hospital /ID# 214670
Sendai, Miyagi, Japan
Okayama University Hospital /ID# 214842
Okayama, Okayama-ken, Japan
Osaka Metropolitan University Hospital /ID# 215227
Osaka, 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, Yamagata, Japan
Seoul National University Hospital /ID# 214891
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 214893
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 239087
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214892
Seoul, Seoul Teugbyeolsi, South Korea
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
Seville, , Spain
Hospital Clinico Universitario de Valencia /ID# 215106
Valencia, , Spain
Duplicate_Universitätsspital Basel /ID# 215892
Basel, Canton of Basel-City, Switzerland
University Hospital Zurich /ID# 215891
Zurich, Canton of Zurich, Switzerland
National Taiwan University Hospital /ID# 215245
Taipei City, Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197
Kaohsiung City, , Taiwan
China Medical University Hospital /ID# 215198
Taichung, , Taiwan
Taichung Veterans General Hospital /ID# 239288
Taichung, , Taiwan
Taipei Veterans General Hosp /ID# 239289
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 215319
Taoyuan, , Taiwan
Hammersmith Hospital /ID# 215665
London, England, United Kingdom
Gartnavel General Hospital /ID# 215663
Glasgow, Glasgow City, United Kingdom
University College London Hospital /ID# 215662
London, Greater London, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 215120
Birmingham, , 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
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359
Newcastle upon Tyne, , United Kingdom
Countries
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Related Links
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Other Identifiers
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2023-507222-17-00
Identifier Type: OTHER
Identifier Source: secondary_id
M19-063
Identifier Type: -
Identifier Source: org_study_id
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