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
VIALE-M
Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
2 other identifiers
interventional
112
19 countries
156
Brief Summary
This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2020
Longer than P75 for phase_3
156 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2019
CompletedFirst Posted
Study publicly available on registry
September 25, 2019
CompletedStudy Start
First participant enrolled
March 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2022
CompletedResults Posted
Study results publicly available
August 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2026
CompletedApril 8, 2026
August 1, 2025
2.5 years
September 23, 2019
July 29, 2025
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination With Azacitidine (AZA) (Part 1)
DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.
Up to 28 days (Cycle 1)
Number of Participants With DLTs of Venetoclax in Combination With Oral AZA (Part 3 Dose Finding Portion)
DLTs are hematologic toxicities consisting of any Grade ≥ 3 neutropenia or thrombocytopenia lasting more than 7 days and nonhematologic toxicities as described in the protocol and evaluated by the Investigator and the Sponsor. In addition, AEs that lead to omitting \> 20% of the scheduled dose within the cycle is considered as a DLT unless clearly related to underlying disease. Treatment delay due to toxicity lasting greater than 14 days since the last dose of Venetoclax is also considered a DLT.
Up to 28 days (Cycle 1)
Study Arms (3)
Part 1: Dose Confirmation
EXPERIMENTALParticipants 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.
Part 3 (Dose Finding): Dose Escalation
EXPERIMENTALParticipants 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).
Part 3 (Dose Finding): Safety Expansion
EXPERIMENTALParticipants 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.
Interventions
Tablet: Oral
Eligibility Criteria
You may qualify if:
- Diagnosis of newly diagnosed acute myeloid leukemia (AML).
- 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.
You may not qualify if:
- History of acute promyelocytic leukemia (APL).
- History of active central nervous system involvement with acute myeloid leukemia (AML).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- Roche-Genentechcollaborator
Study Sites (156)
Mitchell Cancer Institute /ID# 216443
Mobile, Alabama, 36604, United States
Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
Fountain Valley, California, 92708-7501, United States
University of California, Los Angeles /ID# 219149
Los Angeles, California, 90095, United States
Colorado Blood Cancer Institute /ID# 214280
Denver, Colorado, 80218, United States
St. Alphonsus Regional Medical /ID# 216424
Boise, Idaho, 83706, United States
Duplicate_Rush University Medical Center /ID# 218815
Chicago, Illinois, 60612, United States
University of Kentucky Markey Cancer Center /ID# 215048
Lexington, Kentucky, 40536-7001, United States
Duplicate_Norton Cancer Institute /ID# 216401
Louisville, Kentucky, 40202-3700, United States
Tulane Medical Center - New Orleans /ID# 218166
New Orleans, Louisiana, 70112-2600, United States
Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 214583
New Orleans, Louisiana, 70121, United States
Tufts Medical Center /ID# 216110
Boston, Massachusetts, 02111-1552, United States
Massachusetts General Hospital /ID# 217307
Boston, Massachusetts, 02114, United States
Duplicate_UMass Chan Medical School /ID# 218163
Worcester, Massachusetts, 01655, United States
Oncology Hematology Associates (OHA) - Springfield /ID# 216351
Springfield, Missouri, 65807-5287, United States
Saint Louis University Cancer Center /ID# 218164
St Louis, Missouri, 63110-2539, United States
The John Theurer Cancer /ID# 215191
Hackensack, New Jersey, 07601, United States
Rutgers Cancer Institute of New Jersey /ID# 239708
New Brunswick, New Jersey, 08901, United States
Weill Cornell Medical College /ID# 214847
New York, New York, 10065, United States
Providence Portland Medical Ct /ID# 216231
Portland, Oregon, 97213-2933, United States
Fox Chase Cancer Center /ID# 239372
Philadelphia, Pennsylvania, 19111, United States
UPMC Hillman Cancer Ctr /ID# 214051
Pittsburgh, Pennsylvania, 15232, United States
Duplicate_Prisma Health Cancer Institute-Faris Road /ID# 216066
Greenville, South Carolina, 29605-4255, United States
St Francis Cancer Center /ID# 216115
Greenville, South Carolina, 29607-5253, United States
Gibbs Cancer Center & Research /ID# 216192
Spartanburg, South Carolina, 29303-3040, United States
Tennessee Oncology-Nashville Centennial /ID# 218757
Nashville, Tennessee, 37203-1632, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584
Dallas, Texas, 75246-2003, United States
University of Texas MD Anderson Cancer Center /ID# 225201
Houston, Texas, 77030, United States
St George Hospital /ID# 215416
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital /ID# 215415
Liverpool, New South Wales, 2170, Australia
Shoalhaven District Memorial Hospital /ID# 221973
Nowra, New South Wales, 2541, Australia
Wollongong Hospital /ID# 216071
Wollongong, New South Wales, 2500, Australia
Gold coast University Hospital /ID# 214650
Southport, Queensland, 4215, Australia
Toowoomba Hospital /ID# 217922
Toowoomba, Queensland, 4350, Australia
Princess Alexandra Hospital /ID# 238753
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital /ID# 238754
Adelaide, South Australia, 5000, Australia
Box Hill Hospital /ID# 217622
Box Hill, Victoria, 3128, Australia
Barwon Health /ID# 217921
Geelong, Victoria, 3220, Australia
Perth Blood Institute Ltd /ID# 217531
Nedlands, Western Australia, 6009, Australia
Tom Baker Cancer Centre /ID# 214625
Calgary, Alberta, T2N 4N2, Canada
Duplicate_University of Alberta Hospital - Division of Hematology /ID# 215656
Edmonton, Alberta, T6G 2B7, Canada
Juravinski Cancer Centre /ID# 214623
Hamilton, Ontario, L8V 1C3, Canada
London Health Sciences Center- University Hospital /ID# 216055
London, Ontario, N6A 5W9, Canada
Ottawa Hospital Research Institute /ID# 214627
Ottawa, Ontario, K1H 8L6, Canada
University Health Network_Princess Margaret Cancer Centre /ID# 214624
Toronto, Ontario, M5G 2M9, Canada
Duplicate_McGill University Health Center Research Institute /ID# 215984
Montreal, Quebec, H4A 3J1, Canada
Beijing Friendship Hospital /ID# 216455
Beijing, Beijing Municipality, 100032, China
Chinese PLA General Hospital /ID# 216286
Beijing, Beijing Municipality, 100853, China
Peking University International Hospital /ID# 217439
Beijing, Beijing Municipality, 102206, China
Guangdong Provincial People's Hospital /ID# 216284
Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University /ID# 215565
Guangzhou, Guangdong, 510515, China
Henan Cancer Hospital /ID# 215566
Zhengzhou, Henan, 450008, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046
Wuhan, Hubei, 430022, China
Tongji Hospital Tongji Medical College of HUST /ID# 216456
Wuhan, Hubei, 430030, China
Duplicate_Shanghai Tongji Hospital /ID# 218800
Shanghai, Shanghai Municipality, 200065, China
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283
Xi’an, Shanxi, 710038, China
West China Hospital, Sichuan University /ID# 216606
Chengdu, Sichuan, 610041, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558
Tianjin, Tianjin Municipality, 300020, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564
Hangzhou, Zhejiang, 310003, China
Fakultní Nemocnice Brno - Jihlavská /ID# 214807
Brno, Brno-mesto, 625 00, Czechia
Fakultni Nemocnice Ostrava /ID# 214809
Ostrava, Ostrava-mesto, 708 52, Czechia
Ustav hematologie a krevni transfuze /ID# 215137
Prague, 128 00, Czechia
Chu de Nice-Hopital L'Archet Ii /Id# 217368
Nice, Alpes-Maritimes, 06202, France
Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 215150
Pessac, Gironde, 33604, France
CHRU Tours - Hopital Bretonneau /ID# 216186
Tours, Indre-et-Loire, 37044, France
CHRU Lille - Hopital Claude Huriez /ID# 217474
Lille, Nord, 59037, France
Duplicate_CHU de Nantes - Hotel Dieu /ID# 217367
Nantes, Pays de la Loire Region, 44000, France
Centre Hospitalier de la Cote Basque /ID# 216185
Bayonne, Pyrenees-Atlantiques, 64100, France
Centre Hospitalier du Mans /ID# 215148
Le Mans, Sarthe, 72037, France
Institut Gustave Roussy /ID# 215158
Villejuif, Val-de-Marne, 94805, France
Chu Angers /Id# 215151
Angers, 49933, France
Duplicate_Hopital Henri Mondor /ID# 215159
Créteil, 94000, France
Centre Hospitalier de Versailles André Mignot /ID# 215157
Le Chesnay, 78150, France
Hopital Avicenne - APHP /ID# 215152
Bobigny, Île-de-France Region, 93000, France
Universitaetsklinikum Giessen und Marburg /ID# 214734
Marburg, Hesse, 35043, Germany
Duplicate_Klinikum Chemnitz gGmbH /ID# 216073
Chemnitz, Saxony, 09116, Germany
Universitaetsklinikum Leipzig /ID# 214440
Leipzig, Saxony, 04103, Germany
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173
Lübeck, Schleswig-Holstein, 23538, Germany
Universitaetsklinikum Halle (Saale) /ID# 221109
Halle, 06120, Germany
General Hospital of Athens Laiko /ID# 213869
Athens, Attica, 11527, Greece
University General Hospital Attikon /ID# 214298
Athens, Attica, 12462, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 214075
Heraklion, Crete, 71500, Greece
General University Hospital of Alexandroupolis /ID# 213870
Alexandroupoli, 68100, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872
Athens, 10676, Greece
University General Hospital of Patras /ID# 213871
RION Patras Achaia, 26504, Greece
Debreceni Egyetem-Klinikai Kozpont /ID# 214422
Debrecen, Hajdú-Bihar, 4032, Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214426
Kaposvár, Somogy County, 7400, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 214425
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 215644
Szombathely, Vas County, 9700, Hungary
Duplicate_Semmelweis Egyetem /ID# 214423
Budapest, 1085, Hungary
Shaare Zedek Medical Center /ID# 239699
Jerusalem, Jerusalem, 91031, Israel
Hadassah Medical Center-Hebrew University /ID# 239700
Jerusalem, Jerusalem, 91120, Israel
Tel Aviv Sourasky Medical Center /ID# 239698
Tel Aviv, Tel Aviv, 6423906, Israel
Rabin Medical Center /ID# 239696
Petah Tikva, 4941492, Israel
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 213948
Bologna, Emilia-Romagna, 40138, Italy
Duplicate_Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826
Milan, Milano, 20122, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 213946
Milan, Milano, 20162, Italy
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 214505
Turin, Piedmont, 10126, Italy
Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944
Ancona, 60126, Italy
ASST degli Spedali Civili di Brescia /ID# 214580
Brescia, 25123, Italy
Duplicate_A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802
Catania, 95123, Italy
Duplicate_Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947
Naples, 80131, Italy
Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 214278
Naples, 80131, Italy
Ospedale S.Eugenio /ID# 214277
Rome, 00144, Italy
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680
Nagoya, Aichi-ken, 453-8511, Japan
Aichi Cancer Center Hospital /ID# 215284
Nagoya, Aichi-ken, 464-8681, Japan
University of Fukui Hospital /ID# 215283
Yoshida-gun, Fukui, 910-1104, Japan
Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 214841
Fukuoka, Fukuoka, 811-1395, Japan
Kyushu University Hospital /ID# 215286
Fukuoka, Fukuoka, 812-8582, Japan
Duplicate_Hokkaido University Hospital /ID# 215938
Sapporo, Hokkaido, 060-8648, Japan
Duplicate_National Hospital Organization Mito Medical Center /ID# 214699
Higashi Ibaraki-gun, Ibaraki, 311-3193, Japan
Tohoku University Hospital /ID# 214669
Sendai, Miyagi, 9808574, Japan
Duplicate_Nagasaki University Hospital /ID# 214916
Nagasaki, Nagasaki, 852-8501, Japan
Duplicate_Okayama University Hospital /ID# 214840
Okayama, Okayama-ken, 700-8558, Japan
Osaka Metropolitan University Hospital /ID# 215225
Osaka, Osaka, 545-8586, Japan
Kindai University Hospital /ID# 214915
Osakasayama-shi, Osaka, 589-8511, Japan
Saitama Medical University International Medical Center /ID# 214823
Hidaka-shi, Saitama, 350-1298, Japan
NTT Medical Center Tokyo /ID# 214959
Shinagawa-ku, Tokyo, 141-8625, Japan
Yamagata University Hospital /ID# 214698
Yamagata, Yamagata, 990-9585, Japan
Pan American Center for Oncology Trials, LLC /ID# 214953
Rio Piedras, 00935, Puerto Rico
Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126, Russia
Clinic of Immunopathology, SRIFCI /ID# 217937
Novosibirsk, Novosibirsk Oblast, 630047, Russia
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393
Saint Petersburg, Sankt-Peterburg, 197101, Russia
Regional Clinical Hospital of Yaroslavl /ID# 214318
Yaroslavl, Tatarstan, Respublika, 150062, Russia
P. Hertsen Moscow Oncology Research Institute /ID# 214312
Moscow, 125284, Russia
MMCC Kommunarka /ID# 215223
Moscow, 129301, Russia
Almazov National Medical Research Centre /ID# 214306
Saint Petersburg, 197341, Russia
Duplicate_Pusan National University Hospital /ID# 213941
Busan, Busan Gwang Yeogsi, 49241, South Korea
Seoul National University Bundang Hospital /ID# 215549
Seongnam-si, Gyeonggido, 13620, South Korea
Seoul National University Hospital /ID# 213943
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Samsung Medical Center /ID# 213940
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Duplicate_Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Duplicate_Hospital Universitario de Navarra /ID# 214788
Pamplona, Navarre, 31008, Spain
Hospital Santa Creu i Sant Pau /ID# 214714
Barcelona, 08041, Spain
Duplicate_Hospital Universitario Reina Sofia /ID# 214786
Córdoba, 14004, Spain
Hospital Universitario Infanta Leonor /ID# 214843
Madrid, 28031, Spain
MD Anderson Madrid /ID# 214477
Madrid, 28033, Spain
Hospital Universitario Ramon y Cajal /ID# 214684
Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 214933
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre /ID# 214789
Madrid, 28041, Spain
Hospital Universitario Virgen de la Victoria /ID# 214713
Málaga, 29010, Spain
National Taiwan University Hospital /ID# 213939
Taipei City, Taipei, 100, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953
Kaohsiung City, 807, Taiwan
China Medical University Hospital /ID# 213952
Taichung, 40447, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 213951
Taoyuan, 333, Taiwan
Gulhane Askeri Tip Academy /ID# 214242
Ankara, 06010, Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 214239
Ankara, 06590, Turkey (Türkiye)
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 215525
Istanbul, 34098, Turkey (Türkiye)
Erciyes University Medical Faculty /ID# 214240
Kayseri, 38039, Turkey (Türkiye)
Karadeniz University /ID# 214241
Trabzon, 61000, Turkey (Türkiye)
Leicester Royal Infirmary /ID# 215924
Leicester, England, LE1 5WW, United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 215909
London, Greater London, E1 2ES, United Kingdom
Duplicate_UCLH NHS Foundation Trust - University College Hospital /ID# 215921
London, Greater London, NW1 2PG, United Kingdom
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 215908
London, Greater London, SE1 9RT, United Kingdom
Cardiff & Vale University Health Board /ID# 215906
Cardiff, Wales, CF14 4XN, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 215910
Birmingham, B15 2TH, United Kingdom
University Hospitals Bristol /ID# 215911
Bristol, BS1 3NU, United Kingdom
Related Publications (2)
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.
PMID: 35852098DERIVEDShallis 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.
PMID: 33394722DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- AbbVie
- Organization
- ABBVIE CALL CENTER
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 23, 2019
First Posted
September 25, 2019
Study Start
March 26, 2020
Primary Completion
September 29, 2022
Study Completion
February 20, 2026
Last Updated
April 8, 2026
Results First Posted
August 20, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.