Acute Myeloid Leukemia (AML)Phase 3VIALE-MNCT04102020
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
A Phase 3 study testing Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML), run by AbbVie at 156 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Venetoclax and Azacitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 156 sitesin 19 countries
- Study dates
- 26 Mar 2020to 20 Feb 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of acute promyelocytic leukemia (APL).
- History of active central nervous system involvement with acute myeloid leukemia (AML).
Trial locations and contacts
156 sites in 19 countries.
156 sites in 19 countries
United States27 sites
St. Alphonsus Regional Medical /ID# 216424
Boise, Idaho, 83706
Tufts Medical Center /ID# 216110
Boston, Massachusetts, 02111-1552
Massachusetts General Hospital /ID# 217307
Boston, Massachusetts, 02114
Duplicate_Rush University Medical Center /ID# 218815
Chicago, Illinois, 60612
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 214584
Dallas, Texas, 75246-2003
Colorado Blood Cancer Institute /ID# 214280
Denver, Colorado, 80218
Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
Fountain Valley, California, 92708-7501
Duplicate_Prisma Health Cancer Institute-Faris Road /ID# 216066
Greenville, South Carolina, 29605-4255
St Francis Cancer Center /ID# 216115
Greenville, South Carolina, 29607-5253
The John Theurer Cancer /ID# 215191
Hackensack, New Jersey, 07601
University of Texas MD Anderson Cancer Center /ID# 225201
Houston, Texas, 77030
University of Kentucky Markey Cancer Center /ID# 215048
Lexington, Kentucky, 40536-7001
University of California, Los Angeles /ID# 219149
Los Angeles, California, 90095
Duplicate_Norton Cancer Institute /ID# 216401
Louisville, Kentucky, 40202-3700
Mitchell Cancer Institute /ID# 216443
Mobile, Alabama, 36604
Tennessee Oncology-Nashville Centennial /ID# 218757
Nashville, Tennessee, 37203-1632
Rutgers Cancer Institute of New Jersey /ID# 239708
New Brunswick, New Jersey, 08901
Tulane Medical Center - New Orleans /ID# 218166
New Orleans, Louisiana, 70112-2600
Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 214583
New Orleans, Louisiana, 70121
Weill Cornell Medical College /ID# 214847
New York, New York, 10065
Fox Chase Cancer Center /ID# 239372
Philadelphia, Pennsylvania, 19111
UPMC Hillman Cancer Ctr /ID# 214051
Pittsburgh, Pennsylvania, 15232
Providence Portland Medical Ct /ID# 216231
Portland, Oregon, 97213-2933
Gibbs Cancer Center & Research /ID# 216192
Spartanburg, South Carolina, 29303-3040
Oncology Hematology Associates (OHA) - Springfield /ID# 216351
Springfield, Missouri, 65807-5287
Saint Louis University Cancer Center /ID# 218164
St Louis, Missouri, 63110-2539
Duplicate_UMass Chan Medical School /ID# 218163
Worcester, Massachusetts, 01655
Japan15 sites
Duplicate_National Hospital Organization Kyushu Cancer Center /ID# 214841
Fukuoka, Fukuoka, 811-1395
Kyushu University Hospital /ID# 215286
Fukuoka, Fukuoka, 812-8582
Saitama Medical University International Medical Center /ID# 214823
Hidaka-shi, Saitama, 350-1298
Duplicate_National Hospital Organization Mito Medical Center /ID# 214699
Higashi Ibaraki-gun, Ibaraki, 311-3193
Duplicate_Nagasaki University Hospital /ID# 214916
Nagasaki, Nagasaki, 852-8501
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215680
Nagoya, Aichi-ken, 453-8511
Aichi Cancer Center Hospital /ID# 215284
Nagoya, Aichi-ken, 464-8681
Duplicate_Okayama University Hospital /ID# 214840
Okayama, Okayama-ken, 700-8558
Osaka Metropolitan University Hospital /ID# 215225
Osaka, Osaka, 545-8586
Kindai University Hospital /ID# 214915
Osakasayama-shi, Osaka, 589-8511
Duplicate_Hokkaido University Hospital /ID# 215938
Sapporo, Hokkaido, 060-8648
Tohoku University Hospital /ID# 214669
Sendai, Miyagi, 9808574
NTT Medical Center Tokyo /ID# 214959
Shinagawa-ku, Tokyo, 141-8625
Yamagata University Hospital /ID# 214698
Yamagata, Yamagata, 990-9585
University of Fukui Hospital /ID# 215283
Yoshida-gun, Fukui, 910-1104
China13 sites
Beijing Friendship Hospital /ID# 216455
Beijing, Beijing Municipality, 100032
Chinese PLA General Hospital /ID# 216286
Beijing, Beijing Municipality, 100853
Peking University International Hospital /ID# 217439
Beijing, Beijing Municipality, 102206
West China Hospital, Sichuan University /ID# 216606
Chengdu, Sichuan, 610041
Guangdong Provincial People's Hospital /ID# 216284
Guangzhou, Guangdong, 510080
Nanfang Hospital of Southern Medical University /ID# 215565
Guangzhou, Guangdong, 510515
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215564
Hangzhou, Zhejiang, 310003
Duplicate_Shanghai Tongji Hospital /ID# 218800
Shanghai, Shanghai Municipality, 200065
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215558
Tianjin, Tianjin Municipality, 300020
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 218046
Wuhan, Hubei, 430022
Tongji Hospital Tongji Medical College of HUST /ID# 216456
Wuhan, Hubei, 430030
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216283
Xi’an, Shanxi, 710038
Henan Cancer Hospital /ID# 215566
Zhengzhou, Henan, 450008
France12 sites
Chu Angers /Id# 215151
Angers, 49933
Centre Hospitalier de la Cote Basque /ID# 216185
Bayonne, Pyrenees-Atlantiques, 64100
Hopital Avicenne - APHP /ID# 215152
Bobigny, Île-de-France Region, 93000
Duplicate_Hopital Henri Mondor /ID# 215159
Créteil, 94000
Centre Hospitalier de Versailles André Mignot /ID# 215157
Le Chesnay, 78150
Centre Hospitalier du Mans /ID# 215148
Le Mans, Sarthe, 72037
CHRU Lille - Hopital Claude Huriez /ID# 217474
Lille, Nord, 59037
Duplicate_CHU de Nantes - Hotel Dieu /ID# 217367
Nantes, Pays de la Loire Region, 44000
Chu de Nice-Hopital L'Archet Ii /Id# 217368
Nice, Alpes-Maritimes, 06202
Duplicate_CHU Bordeaux - Hopital Haut Leveque /ID# 215150
Pessac, Gironde, 33604
CHRU Tours - Hopital Bretonneau /ID# 216186
Tours, Indre-et-Loire, 37044
Institut Gustave Roussy /ID# 215158
Villejuif, Val-de-Marne, 94805
Australia11 sites
Royal Adelaide Hospital /ID# 238754
Adelaide, South Australia, 5000
Box Hill Hospital /ID# 217622
Box Hill, Victoria, 3128
Barwon Health /ID# 217921
Geelong, Victoria, 3220
St George Hospital /ID# 215416
Kogarah, New South Wales, 2217
Liverpool Hospital /ID# 215415
Liverpool, New South Wales, 2170
Perth Blood Institute Ltd /ID# 217531
Nedlands, Western Australia, 6009
Shoalhaven District Memorial Hospital /ID# 221973
Nowra, New South Wales, 2541
Gold coast University Hospital /ID# 214650
Southport, Queensland, 4215
Toowoomba Hospital /ID# 217922
Toowoomba, Queensland, 4350
Wollongong Hospital /ID# 216071
Wollongong, New South Wales, 2500
Princess Alexandra Hospital /ID# 238753
Woolloongabba, Queensland, 4102
Italy10 sites
Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 213944
Ancona, 60126
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 213948
Bologna, Emilia-Romagna, 40138
ASST degli Spedali Civili di Brescia /ID# 214580
Brescia, 25123
Duplicate_A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 214802
Catania, 95123
Duplicate_Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 214826
Milan, Milano, 20122
ASST Grande Ospedale Metropolitano Niguarda /ID# 213946
Milan, Milano, 20162
Duplicate_Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 213947
Naples, 80131
Duplicate_Azienda Ospedaliera Universitaria Federico II /ID# 214278
Naples, 80131
Ospedale S.Eugenio /ID# 214277
Rome, 00144
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 214505
Turin, Piedmont, 10126
Spain10 sites
Hospital Santa Creu i Sant Pau /ID# 214714
Barcelona, 08041
Duplicate_Hospital Universitario Reina Sofia /ID# 214786
Córdoba, 14004
Duplicate_Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 214715
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario Infanta Leonor /ID# 214843
Madrid, 28031
MD Anderson Madrid /ID# 214477
Madrid, 28033
Hospital Universitario Ramon y Cajal /ID# 214684
Madrid, 28034
Hospital Universitario Fundacion Jimenez Diaz /ID# 214933
Madrid, 28040
Hospital Universitario 12 de Octubre /ID# 214789
Madrid, 28041
Hospital Universitario Virgen de la Victoria /ID# 214713
Málaga, 29010
Duplicate_Hospital Universitario de Navarra /ID# 214788
Pamplona, Navarre, 31008
Canada7 sites
Tom Baker Cancer Centre /ID# 214625
Calgary, Alberta, T2N 4N2
Duplicate_University of Alberta Hospital - Division of Hematology /ID# 215656
Edmonton, Alberta, T6G 2B7
Juravinski Cancer Centre /ID# 214623
Hamilton, Ontario, L8V 1C3
London Health Sciences Center- University Hospital /ID# 216055
London, Ontario, N6A 5W9
Duplicate_McGill University Health Center Research Institute /ID# 215984
Montreal, Quebec, H4A 3J1
Ottawa Hospital Research Institute /ID# 214627
Ottawa, Ontario, K1H 8L6
University Health Network_Princess Margaret Cancer Centre /ID# 214624
Toronto, Ontario, M5G 2M9
Russia7 sites
P. Hertsen Moscow Oncology Research Institute /ID# 214312
Moscow, 125284
MMCC Kommunarka /ID# 215223
Moscow, 129301
Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 214309
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126
Clinic of Immunopathology, SRIFCI /ID# 217937
Novosibirsk, Novosibirsk Oblast, 630047
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 215393
Saint Petersburg, Sankt-Peterburg, 197101
Almazov National Medical Research Centre /ID# 214306
Saint Petersburg, 197341
Regional Clinical Hospital of Yaroslavl /ID# 214318
Yaroslavl, Tatarstan, Respublika, 150062
United Kingdom7 sites
University Hospitals Birmingham NHS Foundation Trust /ID# 215910
Birmingham, B15 2TH
University Hospitals Bristol /ID# 215911
Bristol, BS1 3NU
Cardiff & Vale University Health Board /ID# 215906
Cardiff, Wales, CF14 4XN
Leicester Royal Infirmary /ID# 215924
Leicester, England, LE1 5WW
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 215909
London, Greater London, E1 2ES
Duplicate_UCLH NHS Foundation Trust - University College Hospital /ID# 215921
London, Greater London, NW1 2PG
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 215908
London, Greater London, SE1 9RT
Greece6 sites
General University Hospital of Alexandroupolis /ID# 213870
Alexandroupoli, 68100
General Hospital of Athens Laiko /ID# 213869
Athens, Attica, 11527
University General Hospital Attikon /ID# 214298
Athens, Attica, 12462
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213872
Athens, 10676
University General Hospital of Heraklion PA.G.N.I /ID# 214075
Heraklion, Crete, 71500
University General Hospital of Patras /ID# 213871
RION Patras Achaia, 26504
Germany5 sites
Duplicate_Klinikum Chemnitz gGmbH /ID# 216073
Chemnitz, Saxony, 09116
Universitaetsklinikum Halle (Saale) /ID# 221109
Halle, 06120
Universitaetsklinikum Leipzig /ID# 214440
Leipzig, Saxony, 04103
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 215173
Lübeck, Schleswig-Holstein, 23538
Universitaetsklinikum Giessen und Marburg /ID# 214734
Marburg, Hesse, 35043
Hungary5 sites
Duplicate_Semmelweis Egyetem /ID# 214423
Budapest, 1085
Debreceni Egyetem-Klinikai Kozpont /ID# 214422
Debrecen, Hajdú-Bihar, 4032
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 214426
Kaposvár, Somogy County, 7400
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 214425
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 215644
Szombathely, Vas County, 9700
Turkey (Türkiye)5 sites
Gulhane Askeri Tip Academy /ID# 214242
Ankara, 06010
Ankara Univ Medical Faculty /ID# 214239
Ankara, 06590
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 215525
Istanbul, 34098
Erciyes University Medical Faculty /ID# 214240
Kayseri, 38039
Karadeniz University /ID# 214241
Trabzon, 61000
Israel4 sites
Shaare Zedek Medical Center /ID# 239699
Jerusalem, Jerusalem, 91031
Hadassah Medical Center-Hebrew University /ID# 239700
Jerusalem, Jerusalem, 91120
Rabin Medical Center /ID# 239696
Petah Tikva, 4941492
Tel Aviv Sourasky Medical Center /ID# 239698
Tel Aviv, Tel Aviv, 6423906
South Korea4 sites
Duplicate_Pusan National University Hospital /ID# 213941
Busan, Busan Gwang Yeogsi, 49241
Seoul National University Bundang Hospital /ID# 215549
Seongnam-si, Gyeonggido, 13620
Seoul National University Hospital /ID# 213943
Seoul, Seoul Teugbyeolsi, 03080
Samsung Medical Center /ID# 213940
Seoul, Seoul Teugbyeolsi, 06351
Taiwan4 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953
Kaohsiung City, 807
China Medical University Hospital /ID# 213952
Taichung, 40447
National Taiwan University Hospital /ID# 213939
Taipei City, Taipei, 100
Linkou Chang Gung Memorial Hospital /ID# 213951
Taoyuan City, 333
Czechia3 sites
Fakultní Nemocnice Brno - Jihlavská /ID# 214807
Brno, Brno-mesto, 625 00
Fakultni Nemocnice Ostrava /ID# 214809
Ostrava, Ostrava-mesto, 708 52
Ustav hematologie a krevni transfuze /ID# 215137
Prague, 128 00
Puerto Rico1 site
Pan American Center for Oncology Trials, LLC /ID# 214953
Rio Piedras, 00935
About this study
Official title: Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
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.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Venetoclax, Azacitidine
- Keywords
- Acute myeloid leukemia (AML), Venetoclax, Azacitidine (AZA), Maintenance Therapy, Conventional Chemotherapy, Best supportive care (BSC)
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Also called ABT-199, GDC-0199, Venclexta
Tablet: Oral
AzacitidineDrug
Subcutaneous (SC) or intravenous (IV) injection
AzacitidineDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Confirmation | Experimental | 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. Receives: Drug: Venetoclax; Drug: Azacitidine |
| Part 3 (Dose Finding): Dose Escalation | Experimental | 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). Receives: Drug: Venetoclax; Drug: Azacitidine |
| Part 3 (Dose Finding): Safety Expansion | Experimental | 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. Receives: Drug: Venetoclax; Drug: Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 28 days (Cycle 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start26 Mar 2020
- Primary completion29 Sep 2022
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche-Genentech
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102020
- Sponsor's protocol ID
- M19-708
- Other IDs
- 2023-507221-42-00, 2023
- Acronym
- VIALE-M
- Status last verified
- Aug 2025
- First submitted
- 23 Sep 2019
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available
Publications
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.
PubMed 35852098Shallis 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.
PubMed 33394722