A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
NCT ID: NCT04102020
Last Updated: 2025-08-20
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
112 participants
INTERVENTIONAL
2020-03-26
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Confirmation
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax
Tablet: Oral
Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
Part 3 (Dose Finding): Dose Escalation
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).
Venetoclax
Tablet: Oral
Azacitidine
Oral Tablet
Part 3 (Dose Finding): Safety Expansion
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.
Venetoclax
Tablet: Oral
Azacitidine
Oral Tablet
Interventions
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Venetoclax
Tablet: Oral
Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
Azacitidine
Oral Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant meets the following disease activity criteria:
* Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
* Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies.
* AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
* Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
Exclusion Criteria
* History of active central nervous system involvement with acute myeloid leukemia (AML).
18 Years
ALL
No
Sponsors
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Roche-Genentech
INDUSTRY
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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Mitchell Cancer Institute /ID# 216443
Mobile, Alabama, United States
Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
Fountain Valley, California, United States
University of California, Los Angeles /ID# 219149
Los Angeles, California, United States
Colorado Blood Cancer Institute /ID# 214280
Denver, Colorado, United States
St. Alphonsus Regional Medical /ID# 216424
Boise, Idaho, United States
Duplicate_Rush University Medical Center /ID# 218815
Chicago, Illinois, United States
University of Kentucky Markey Cancer Center /ID# 215048
Lexington, Kentucky, United States
Duplicate_Norton Cancer Institute /ID# 216401
Louisville, Kentucky, United States
Tulane Medical Center - New Orleans /ID# 218166
New Orleans, Louisiana, United States
Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 214583
New Orleans, Louisiana, United States
Tufts Medical Center /ID# 216110
Boston, Massachusetts, United States
Massachusetts General Hospital /ID# 217307
Boston, Massachusetts, United States
Duplicate_UMass Chan Medical School /ID# 218163
Worcester, Massachusetts, United States
Oncology Hematology Associates (OHA) - Springfield /ID# 216351
Springfield, Missouri, United States
Saint Louis University Cancer Center /ID# 218164
St Louis, Missouri, United States
The John Theurer Cancer /ID# 215191
Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey /ID# 239708
New Brunswick, New Jersey, United States
Weill Cornell Medical College /ID# 214847
New York, New York, United States
Providence Portland Medical Ct /ID# 216231
Portland, Oregon, United States
Fox Chase Cancer Center /ID# 239372
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Ctr /ID# 214051
Pittsburgh, Pennsylvania, United States
Duplicate_Prisma Health Cancer Institute-Faris Road /ID# 216066
Greenville, South Carolina, United States
St Francis Cancer Center /ID# 216115
Greenville, South Carolina, United States
Gibbs Cancer Center & Research /ID# 216192
Spartanburg, South Carolina, United States
Tennessee Oncology-Nashville Centennial /ID# 218757
Nashville, Tennessee, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center /ID# 225201
Houston, Texas, United States
St George Hospital /ID# 215416
Kogarah, New South Wales, Australia
Liverpool Hospital /ID# 215415
Liverpool, New South Wales, Australia
Shoalhaven District Memorial Hospital /ID# 221973
Nowra, New South Wales, Australia
Wollongong Hospital /ID# 216071
Wollongong, New South Wales, Australia
Gold coast University Hospital /ID# 214650
Southport, Queensland, Australia
Toowoomba Hospital /ID# 217922
Toowoomba, Queensland, Australia
Princess Alexandra Hospital /ID# 238753
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital /ID# 238754
Adelaide, South Australia, Australia
Box Hill Hospital /ID# 217622
Box Hill, Victoria, Australia
Barwon Health /ID# 217921
Geelong, Victoria, Australia
Perth Blood Institute Ltd /ID# 217531
Nedlands, Western Australia, Australia
Tom Baker Cancer Centre /ID# 214625
Calgary, Alberta, Canada
Duplicate_University of Alberta Hospital - Division of Hematology /ID# 215656
Edmonton, Alberta, Canada
Juravinski Cancer Centre /ID# 214623
Hamilton, Ontario, Canada
London Health Sciences Center- University Hospital /ID# 216055
London, Ontario, Canada
Duplicate_Hokkaido University Hospital /ID# 215938
Sapporo, Hokkaido, Japan
Ottawa Hospital Research Institute /ID# 214627
Ottawa, Ontario, Canada
University Health Network_Princess Margaret Cancer Centre /ID# 214624
Toronto, Ontario, Canada
Duplicate_McGill University Health Center Research Institute /ID# 215984
Montreal, Quebec, Canada
Beijing Friendship Hospital /ID# 216455
Beijing, Beijing Municipality, China
Duplicate_National Hospital Organization Mito Medical Center /ID# 214699
Higashi Ibaraki-gun, Ibaraki, Japan
Tohoku University Hospital /ID# 214669
Sendai, Miyagi, Japan
Chinese PLA General Hospital /ID# 216286
Beijing, Beijing Municipality, China
Peking University International Hospital /ID# 217439
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital /ID# 216284
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 215565
Guangzhou, Guangdong, China
Henan Cancer Hospital /ID# 215566
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046
Wuhan, Hubei, China
Tongji Hospital Tongji Medical College of HUST /ID# 216456
Wuhan, Hubei, China
Duplicate_Shanghai Tongji Hospital /ID# 218800
Shanghai, Shanghai Municipality, China
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283
Xi’an, Shanxi, China
West China Hospital, Sichuan University /ID# 216606
Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564
Hangzhou, Zhejiang, China
Fakultní Nemocnice Brno - Jihlavská /ID# 214807
Brno, Brno-mesto, Czechia
Fakultni Nemocnice Ostrava /ID# 214809
Ostrava, Ostrava-mesto, Czechia
Ustav hematologie a krevni transfuze /ID# 215137
Prague, , Czechia
Chu de Nice-Hopital L'Archet Ii /Id# 217368
Nice, Alpes-Maritimes, France
Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 215150
Pessac, Gironde, France
CHRU Tours - Hopital Bretonneau /ID# 216186
Tours, Indre-et-Loire, France
CHRU Lille - Hopital Claude Huriez /ID# 217474
Lille, Nord, France
Duplicate_CHU de Nantes - Hotel Dieu /ID# 217367
Nantes, Pays de la Loire Region, France
Centre Hospitalier de la Cote Basque /ID# 216185
Bayonne, Pyrenees-Atlantiques, France
Centre Hospitalier du Mans /ID# 215148
Le Mans, Sarthe, France
Institut Gustave Roussy /ID# 215158
Villejuif, Val-de-Marne, France
Chu Angers /Id# 215151
Angers, , France
Duplicate_Hopital Henri Mondor /ID# 215159
Créteil, , France
Centre Hospitalier de Versailles André Mignot /ID# 215157
Le Chesnay, , France
Hopital Avicenne - APHP /ID# 215152
Bobigny, Île-de-France Region, France
Universitaetsklinikum Giessen und Marburg /ID# 214734
Marburg, Hesse, Germany
Duplicate_Klinikum Chemnitz gGmbH /ID# 216073
Chemnitz, Saxony, Germany
Universitaetsklinikum Leipzig /ID# 214440
Leipzig, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173
Lübeck, Schleswig-Holstein, Germany
Universitaetsklinikum Halle (Saale) /ID# 221109
Halle, , Germany
General Hospital of Athens Laiko /ID# 213869
Athens, Attica, Greece
University General Hospital Attikon /ID# 214298
Athens, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 214075
Heraklion, Crete, Greece
General University Hospital of Alexandroupolis /ID# 213870
Alexandroupoli, , Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872
Athens, , Greece
University General Hospital of Patras /ID# 213871
RION Patras Achaia, , Greece
Debreceni Egyetem-Klinikai Kozpont /ID# 214422
Debrecen, Hajdú-Bihar, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214426
Kaposvár, Somogy County, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 214425
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 215644
Szombathely, Vas County, Hungary
Duplicate_Semmelweis Egyetem /ID# 214423
Budapest, , Hungary
Shaare Zedek Medical Center /ID# 239699
Jerusalem, Jerusalem, Israel
Hadassah Medical Center-Hebrew University /ID# 239700
Jerusalem, Jerusalem, Israel
Tel Aviv Sourasky Medical Center /ID# 239698
Tel Aviv, Tel Aviv, Israel
Rabin Medical Center /ID# 239696
Petah Tikva, , Israel
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 213948
Bologna, Emilia-Romagna, Italy
Duplicate_Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826
Milan, Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 213946
Milan, Milano, Italy
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 214505
Turin, Piedmont, Italy
Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944
Ancona, , Italy
ASST degli Spedali Civili di Brescia /ID# 214580
Brescia, , Italy
Duplicate_A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802
Catania, , Italy
Duplicate_Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947
Napoli, , Italy
Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 214278
Napoli, , Italy
Ospedale S.Eugenio /ID# 214277
Rome, , Italy
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680
Nagoya, Aichi-ken, Japan
Aichi Cancer Center Hospital /ID# 215284
Nagoya, Aichi-ken, Japan
University of Fukui Hospital /ID# 215283
Yoshida-gun, Fukui, Japan
Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 214841
Fukuoka, Fukuoka, Japan
Kyushu University Hospital /ID# 215286
Fukuoka, Fukuoka, Japan
Duplicate_Nagasaki University Hospital /ID# 214916
Nagasaki, Nagasaki, Japan
Duplicate_Okayama University Hospital /ID# 214840
Okayama, Okayama-ken, Japan
Osaka Metropolitan University Hospital /ID# 215225
Osaka, Osaka, Japan
Kindai University Hospital /ID# 214915
Osakasayama-shi, Osaka, Japan
Saitama Medical University International Medical Center /ID# 214823
Hidaka-shi, Saitama, Japan
NTT Medical Center Tokyo /ID# 214959
Shinagawa-ku, Tokyo, Japan
Yamagata University Hospital /ID# 214698
Yamagata, Yamagata, Japan
Pan American Center for Oncology Trials, LLC /ID# 214953
Rio Piedras, , Puerto Rico
Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Clinic of Immunopathology, SRIFCI /ID# 217937
Novosibirsk, Novosibirsk Oblast, Russia
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393
Saint Petersburg, Sankt-Peterburg, Russia
Regional Clinical Hospital of Yaroslavl /ID# 214318
Yaroslavl, Tatarstan, Respublika, Russia
P. Hertsen Moscow Oncology Research Institute /ID# 214312
Moscow, , Russia
MMCC Kommunarka /ID# 215223
Moscow, , Russia
Almazov National Medical Research Centre /ID# 214306
Saint Petersburg, , Russia
Duplicate_Pusan National University Hospital /ID# 213941
Busan, Busan Gwang Yeogsi, South Korea
Seoul National University Bundang Hospital /ID# 215549
Seongnam-si, Gyeonggido, South Korea
Seoul National University Hospital /ID# 213943
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 213940
Seoul, Seoul Teugbyeolsi, South Korea
Duplicate_Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715
L'Hospitalet de Llobregat, Barcelona, Spain
Duplicate_Hospital Universitario de Navarra /ID# 214788
Pamplona, Navarre, Spain
Hospital Santa Creu i Sant Pau /ID# 214714
Barcelona, , Spain
Duplicate_Hospital Universitario Reina Sofia /ID# 214786
Córdoba, , Spain
Hospital Universitario Infanta Leonor /ID# 214843
Madrid, , Spain
MD Anderson Madrid /ID# 214477
Madrid, , Spain
Hospital Universitario Ramon y Cajal /ID# 214684
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 214933
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 214789
Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 214713
Málaga, , Spain
National Taiwan University Hospital /ID# 213939
Taipei City, Taipei, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953
Kaohsiung City, , Taiwan
China Medical University Hospital /ID# 213952
Taichung, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 213951
Taoyuan, , Taiwan
Gulhane Askeri Tip Academy /ID# 214242
Ankara, , Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 214239
Ankara, , Turkey (Türkiye)
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 215525
Istanbul, , Turkey (Türkiye)
Erciyes University Medical Faculty /ID# 214240
Kayseri, , Turkey (Türkiye)
Karadeniz University /ID# 214241
Trabzon, , Turkey (Türkiye)
Leicester Royal Infirmary /ID# 215924
Leicester, England, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 215909
London, Greater London, United Kingdom
Duplicate_UCLH NHS Foundation Trust - University College Hospital /ID# 215921
London, Greater London, United Kingdom
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 215908
London, Greater London, United Kingdom
Cardiff & Vale University Health Board /ID# 215906
Cardiff, Wales, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 215910
Birmingham, , United Kingdom
University Hospitals Bristol /ID# 215911
Bristol, , United Kingdom
Countries
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References
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Ivanov V, Yeh SP, Mayer J, Saini L, Unal A, Boyiadzis M, Hoffman DM, Kang K, Addo SN, Mendes WL, Fathi AT. Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia. Future Oncol. 2022 Aug;18(26):2879-2889. doi: 10.2217/fon-2022-0450. Epub 2022 Jul 19.
Shallis RM, Podoltsev NA. Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission. Curr Opin Hematol. 2021 Mar 1;28(2):110-121. doi: 10.1097/MOH.0000000000000637.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2023-507221-42-00
Identifier Type: OTHER
Identifier Source: secondary_id
M19-708
Identifier Type: -
Identifier Source: org_study_id
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