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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Other trials in United States

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

Other trials in Japan

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

Other trials in China

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

Other trials in France

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

Other trials in Australia

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

Other trials in Italy

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

Other trials in Spain

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

Other trials in Canada

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

Other trials in Russia

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

Other trials in United Kingdom

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

Other trials in Greece

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

Other trials in Germany

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

Other trials in Hungary

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

Other trials in Turkey (Türkiye)

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

Other trials in Israel

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

Other trials in South Korea

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

Other trials in Taiwan

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

Other trials in Czechia

Puerto Rico1 site

  • Pan American Center for Oncology Trials, LLC /ID# 214953

    Rio Piedras, 00935

Other trials in Puerto Rico

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.

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.

Study groups in NCT04102020
Study groupRoleWhat they receive
Part 1: Dose ConfirmationExperimentalParticipants 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 EscalationExperimentalParticipants 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 ExpansionExperimentalParticipants 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.

  1. 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)

  2. 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.

  1. First posted25 Sep 2019
  2. Study start26 Mar 2020
  3. Primary completion29 Sep 2022
  4. Study completion20 Feb 2026

Resources

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)
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
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 35852098

  • 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.

    PubMed 33394722

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Venetoclax and Azacitidine in people with Acute Myeloid Leukemia (AML), run by AbbVie at 156 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, Japan, China, France, Australia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination With Azacitidine (AZA) (Part 1) (time frame: Up to 28 days (Cycle 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04102020, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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