AzTrials
AzTrials

Acute Myeloid Leukemia (AML)Phase 3Viale-aNCT02993523

A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

A Phase 3 study testing Azacitidine and Venetoclax in people with Acute Myeloid Leukemia (AML), run by AbbVie at 172 sites in 29 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed. 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?
Azacitidine and Venetoclax
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
443 participants
Where
172 sitesin 29 countries
Study dates
2 Feb 2017to 15 Jun 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

  • Participant must have confirmation of Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria, previously untreated and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due age or comorbidities.
  • Participant must be >= 18 years of age.
  • Participant must have a projected life expectancy of at least 12 weeks.
  • Participant must be considered ineligible for induction therapy defined by the following:
  • >= 75 years of age; or b. >= 18 to 74 years of age with at least one of the following comorbidities: i. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3; ii. Cardiac history of Congestive Heart Failure (CHF) requiring treatment or Ejection Fraction <= 50% or chronic stable angina; iii. Diffusing capacity of the Lung for Carbon Monoxide (DLCO) <= 65% or Forced Expiratory Volume in 1 second (FEV1) <= 65%; iv. Creatinine clearance >= 30 mL/min to < 45 ml/min; v. Moderate hepatic impairment with total bilirubin > 1.5 to <= 3.0 × Upper Limit of Normal (ULN); vi. Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the AbbVie Therapeutic Medical Director during screening and before study enrollment.
  • Participant must have an ECOG Performance status:
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  • 0 to 2 for Participants >= 75 years of age or
  • 0 to 3 for Participants >= 18 to 74 years of age.
  • Participant must have adequate renal function as demonstrated by a creatinine >= 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.
  • Participant must have adequate liver function as demonstrated by:
  • aspartate aminotransferase (AST) <= 3.0 x ULN*
  • alanine aminotransferase (ALT) <= 3.0 x ULN*
  • bilirubin <= 1.5 x ULN* * Unless considered to be due to leukemic organ involvement
  • Participants who are < 75 years of age may have a bilirubin of <= 3.0 x ULN
  • Female participants must be either postmenopausal defined as:
  • Age > 55 years with no menses for 12 or more months without an alternative medical cause.
  • Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an follicle stimulating hormone (FSH) level >40 international units per liter (IU/L); or
  • Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); or
  • Women of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control, starting at Study Day 1 through at least 90 days after the last dose of study drug.
  • Male participants who are sexually active, must agree, from Study Day 1 through at least 90 days after the last dose of study drug, to practice the protocol specified contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 90 days after the last dose of study drug.
  • Female participants of childbearing potential must have negative results for pregnancy test performed:
  • At Screening with a serum sample obtained within 14 days prior to the first study drug administration, and
  • Prior to dosing with urine sample obtained on Cycle 1 Day 1, if it has been > 7 days since obtaining the serum pregnancy test results.
  • Participant must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Who cannot join

  • Participant has received treatment with the following:
  • A hypomethylating agent, venetoclax and/or chemo therapeutic agent for Myelodysplastic syndrome (MDS).
  • Chimeric Antigen Receptor (CAR)-T cell therapy.
  • Experimental therapies for MDS or Acute Myeloid Leukemia (AML).
  • Current participation in another research or observational study.
  • Participant has history of myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
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  • Participant has the following:
  • Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;17) as per the National Comprehensive Cancer Network (NCCN) Guidelines Version 2, 2016 for Acute Myeloid Leukemia.
  • Participant has acute promyelocytic leukemia
  • Participant has known active central nervous system (CNS) involvement with AML.
  • Participant has known human immunodeficiency virus (HIV) infection (due to potential drug-drug interactions between antiretroviral medications and venetoclax) HIV testing will be performed at Screening, only if required per local guidelines or institutional standards.
  • Participant is known to be positive for hepatitis B or C infection [HCV Ab indicative of a previous or current infection; and/or positive HBs Ag or detected sensitivity on hepatitis B virus (HBV) deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) test for HBc Ab and/or HBs Ab positivity] with the exception of those with an undetectable viral load within 3 months screening. Hepatitis B or C testing is not required.
  • Participant has received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment; additional details as described in the protocol.
  • Participant has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.
  • Participant has a cardiovascular disability status of New York Heart Association Class > 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.
  • Participant has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients of azacitidine that in the opinion of the investigator would adversely affect his/her participating in this study.
  • Participant has a malabsorption syndrome or other condition that precludes enteral route of administration.
  • Participant exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).
  • Participant has a history of other malignancies within 2 years prior to study entry, with the exception of:
  • 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; requires discussion with TA MD.
  • Participant has a white blood cell count > 25 × 10^9/L. (Hydroxyurea or leukapheresis are permitted to meet this criterion.)

Trial locations and contacts

172 sites in 29 countries.

172 sites in 29 countries

United States24 sites

  • Emory Midtown Infectious Disease Clinic /ID# 162534

    Atlanta, Georgia, 30322

  • Johns Hopkins University /ID# 154104

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital /ID# 200752

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center /ID# 201155

    Boston, Massachusetts, 02215-5400

  • Dana-Farber Cancer Institute /ID# 167009

    Boston, Massachusetts, 02215

  • EMMC Cancer Care /ID# 154991

    Brewer, Maine, 04412

  • University Of Vermont Medical /ID# 157196

    Burlington, Vermont, 05405

  • Northwestern University Feinberg School of Medicine /ID# 201133

    Chicago, Illinois, 60611-2927

  • University of Chicago Medicine /ID# 154108

    Chicago, Illinois, 60637-1426

  • City of Hope /ID# 154105

    Duarte, California, 91010

  • Duke Cancer Center /ID# 154106

    Durham, North Carolina, 27710-3000

  • Fort Wayne Medical Oncology /ID# 157190

    Fort Wayne, Indiana, 46804

  • Sepctrum Health Medical Center /ID# 159522

    Grand Rapids, Michigan, 49503

  • University of Texas MD Anderson Cancer Center /ID# 154100

    Houston, Texas, 77030

  • University of California, Los Angeles /ID# 154107

    Los Angeles, California, 90095

  • Norton Cancer Institute /ID# 154992

    Louisville, Kentucky, 40202-3700

  • Tennessee Oncology-Nashville Centennial /ID# 200854

    Nashville, Tennessee, 37203-1632

  • Columbia Univ Medical Center /ID# 154101

    New York, New York, 10032-3725

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077

    New York, New York, 10065-6007

  • University of Pittsburgh MC /ID# 154102

    Pittsburgh, Pennsylvania, 15260

  • University of California, Davis Comprehensive Cancer Center /ID# 162725

    Sacramento, California, 95817

  • University of Utah /ID# 157192

    Salt Lake City, Utah, 84112-5500

  • Baylor Scott & White Medical Center- Temple /ID# 157191

    Temple, Texas, 76508-0001

  • Cotton-O'Neil Clinical Res Ctr /ID# 155136

    Topeka, Kansas, 66606

Other trials in United States

Japan19 sites

  • Juntendo University Hospital /ID# 168309

    Bunkyo-ku, Tokyo, 113-8431

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 168639

    Bunkyo-ku, Tokyo, 113-8677

  • National Hospital Organization Kyushu Cancer Center /ID# 201111

    Fukuoka, Fukuoka, 811-1395

  • Kyushu University Hospital /ID# 169095

    Fukuoka, Fukuoka, 812-8582

  • Saitama Medical University International Medical Center /ID# 167814

    Hidaka-shi, Saitama, 350-1298

  • National Hospital Organization Mito Medical Center /ID# 168219

    Higashi, Ibaraki, 311-3193

  • Hitachi General Hospital /ID# 201109

    Hitachi-shi, Ibaraki, 317-0077

  • The Jikei University Daisan Hospital /ID# 168745

    Komae-shi, Tokyo, 201-8601

  • Duplicate_Kyoto Prefectural University of Medicine /ID# 167661

    Kyoto, Kyoto, 602-8566

  • Gunmaken Saiseikai Maebashi Hospital /ID# 168316

    Maebashi, Gunma, 371-0821

  • Nagasaki University Hospital /ID# 168632

    Nagasaki, Nagasaki, 852-8501

  • Aichi Cancer Center Hospital /ID# 200824

    Nagoya, Aichi-ken, 464-8681

  • Okayama University Hospital /ID# 204124

    Okayama, Okayama-ken, 700-8558

  • Osaka Metropolitan University Hospital /ID# 169055

    Osaka, Osaka, 545-8586

  • Duplicate_Kindai University Hospital /ID# 167662

    Osaka-sayama-shi, Osaka, 589-8511

  • Tohoku University Hospital /ID# 169259

    Sendai, Miyagi, 9808574

  • NTT Medical Center Tokyo /ID# 167975

    Shinagawa-ku, Tokyo, 141-8625

  • Yamagata University Hospital /ID# 167634

    Yamagata, Yamagata, 990-9585

  • University of Fukui Hospital /ID# 167432

    Yoshida-gun, Fukui, 910-1193

Other trials in Japan

China13 sites

  • The First Hospital of Jilin University /ID# 167490

    Changchun, Jilin, 130021

  • West China Hospital, Sichuan University /ID# 167492

    Chengdu, Sichuan, 610041

  • Fujian Medical University Union Hospital /ID# 167314

    Fuzhou, Fujian, 350001

  • Nanfang Hospital of Southern Medical University /ID# 170148

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 167317

    Hangzhou, Zhejiang, 310006

  • Qilu Hospital of Shandong University /ID# 167485

    Jinan, 250012

  • Jiangsu Province Hospital /ID# 167489

    Nanjing, Jiangsu, 210029

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 167318

    Shanghai, Shanghai Municipality, 200065

  • The Second Hospital of Hebei Medical University /ID# 167316

    Shijiazhuang, Hebei, 050000

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 167487

    Tianjin, Tianjin Municipality, 300020

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167315

    Wuhan, Hubei, 430022

  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167493

    Wuhan, Hubei, 430022

  • Henan Cancer Hospital /ID# 167320

    Zhengzhou, Henan, 450008

Other trials in China

Italy10 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 171220

    Ancona, 60126

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 152875

    Bergamo, 24127

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 152883

    Bologna, 40138

  • Ospedale Policlinico San Martino /ID# 158104

    Genova, 16132

  • Presidio Ospedaliero Vito Fazzi /ID# 170837

    Lecce, Apulia, 73100

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882

    Milan, 20122

  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 152879

    Naples, 80131

  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 152877

    Reggio Calabria, 89124

  • Fondazione PTV Policlinico Tor Vergata /ID# 152881

    Rome, Roma, 00133

  • Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 152876

    Rome, 00189

Other trials in Italy

Russia8 sites

  • Kuzbass Regional Clinical Hospital /ID# 157461

    Kemerovo, Kemerovo Oblast, 650099

  • Moscow State budget healthcare /ID# 155738

    Moscow, Moscow, 125284

  • Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 155740

    Moscow, 125167

  • Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 153268

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603126

  • Duplicate_Regional Oncology Dispensary /ID# 153264

    Penza, Penza Oblast, 440071

  • State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 157460

    Ryazan, Ryazan Oblast, 390039

  • Samara State Medical University /ID# 157462

    Samara, 443099

  • Saratov State Medical University n.a. V.I. Razumovskiy /ID# 153267

    Saratov, Saratov Oblast, 410012

Other trials in Russia

Spain8 sites

  • Hospital Clinic de Barcelona /ID# 153255

    Barcelona, 08036

  • Hospital Santa Creu i Sant Pau /ID# 153193

    Barcelona, 08041

  • Hospital Universitario de la Princesa /ID# 153256

    Madrid, 28006

  • Hospital General Universitario Gregorio Maranon /ID# 153260

    Madrid, 28007

  • Hospital Universitario 12 de Octubre /ID# 153258

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria /ID# 153257

    Málaga, 29010

  • Hospital Universitario de Navarra /ID# 153254

    Pamplona, Navarre, 31008

  • Hospital Universitario y Politecnico La Fe /ID# 153259

    Valencia, 46026

Other trials in Spain

Australia7 sites

  • Royal Adelaide Hospital /ID# 154271

    Adelaide, South Australia, 5000

  • Alfred Health /ID# 154275

    Melbourne, Victoria, 3004

  • St Vincent's Hospital Melbourne /ID# 155094

    Melbourne, Victoria, 3065

  • Sir Charles Gairdner Hospital /ID# 163924

    Nedlands, Western Australia, 6009

  • The Royal Melbourne Hospital /ID# 155095

    Parkville, Victoria, 3050

  • Royal Perth Hospital /ID# 154274

    Perth, Western Australia, 6000

  • Princess Alexandra Hospital /ID# 154272

    Woolloongabba, Queensland, 4102

Other trials in Australia

Hungary7 sites

  • Semmelweis Egyetem /ID# 153816

    Budapest, 1085

  • Duplicate_Semmelweis Egyetem /ID# 153815

    Budapest, 1088

  • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 158990

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont /ID# 153814

    Debrecen, Hajdú-Bihar, 4032

  • Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813

    Kaposvár, Somogy County, 7400

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 169854

    Nyíregyháza, Nyiregyhaza, 4400

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 153812

    Szeged, Csongrád megye, 6725

Other trials in Hungary

Austria6 sites

  • Medizinische Universitaet Graz /ID# 157882

    Graz, Styria, 8036

  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888

    Linz, Upper Austria, 4010

  • Ordensklinikum Linz GmbH Elisabethinen /ID# 154885

    Linz, Upper Austria, 4010

  • Duplicate_Landeskrankenhaus Salzburg /ID# 169719

    Salzburg, 5020

  • Universitaetsklinikum St. Poelten /ID# 167436

    Sankt Pölten, Lower Austria, 3100

  • Hanusch Krankenhaus /ID# 155676

    Vienna, 1140

Other trials in Austria

Germany6 sites

  • Universitaetsklinikum Frankfurt /ID# 153060

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Halle (Saale) /ID# 153058

    Halle, 06120

  • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 153056

    Hamburg, 20246

  • Medizinische Hochschule Hannover /ID# 153055

    Hanover, 30625

  • Universitaetsklinikum Muenster /ID# 153059

    Münster, North Rhine-Westphalia, 48149

  • Universitaetsklinikum Ulm /ID# 153054

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Israel6 sites

  • Assaf Harofeh Medical Center /ID# 158063

    Be’er Ya‘aqov, 70300

  • Rambam Health Care Campus /ID# 154174

    Haifa, 3109601

  • Hadassah /ID# 154172

    Jerusalem, 91120

  • Rabin Medical Center /ID# 154176

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 154173

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 154175

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Canada5 sites

  • Tom Baker Cancer Centre /ID# 159645

    Calgary, Alberta, T2N 4N2

  • Juravinski Cancer Centre /ID# 153650

    Hamilton, Ontario, L8V 1C3

  • Ottawa Hospital Research Institute /ID# 153541

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Cancer Centre /ID# 153651

    Toronto, Ontario, M5G 2M9

  • St. Paul's Hospital /ID# 159644

    Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Belgium4 sites

  • AZ Sint-Jan Brugge /ID# 154041

    Bruges, 8000

  • UZ Gent /ID# 153392

    Ghent, Oost-Vlaanderen, 9000

  • UZ Brussel /ID# 153393

    Jette, Brussels Capital, 1090

  • UCL Saint-Luc /ID# 153391

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Brazil4 sites

  • Hospital de Clinicas de Porto Alegre /ID# 157779

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 153099

    Ribeirão Preto, São Paulo, 14051-140

  • Instituto de Ensino e Pesquisa São Lucas /ID# 157778

    São Paulo, São Paulo, 01236-030

  • Instituto do Câncer do Estado de São Paulo - ICESP /ID# 153095

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

Czechia4 sites

  • Fakultni Nemocnice Brno /ID# 154019

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove /ID# 154021

    Hradec Králové, 500 05

  • Fakultni nemocnice Ostrava /ID# 154017

    Ostrava, 708 52

  • Fakultni nemocnice Plzen /ID# 154018

    Pilsen, 305 99

Other trials in Czechia

France4 sites

  • Chu Angers /Id# 153792

    Angers, 49933

  • AP-HP - Hopital Saint-Louis /ID# 153787

    Paris, 75010

  • CHU Bordeaux - Hopital Haut Leveque /ID# 153789

    Pessac, Gironde, 33604

  • IUCT Oncopole /ID# 153788

    Toulouse, 31059

Other trials in France

Norway4 sites

  • Haukeland University Hospital /ID# 154281

    Bergen, Hordaland, 5021

  • Drammen Sykehus /ID# 154280

    Drammen, Buskerud, 3004

  • Sykehuset Ostfold Kalnes /ID# 157755

    Grålum, 1714

  • Akershus universitetssykehus /ID# 154279

    Nordlenangen, Akershus, 1474

Other trials in Norway

Sweden4 sites

  • Dup_VO Hematologi /ID# 153174

    Lund, 221 85

  • Karolinska University Hospital /ID# 170003

    Stockholm, 171 76

  • Uddevalla sjukhus /ID# 156875

    Uddevalla, Västra Götaland County, 451 80

  • Akademiska Sjukhuset /ID# 153034

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Taiwan4 sites

  • Changhua Christian Hospital /ID# 153899

    Changhua, Changhua County, 50006

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 153902

    Kaohsiung City, 807

  • China Medical University Hospital /ID# 153904

    Taichung, 40447

  • National Taiwan University Hospital /ID# 153900

    Taipei, 100

Other trials in Taiwan

Ukraine4 sites

  • Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 153511

    Dnipro, 49102

  • Kyiv city clinical hospital #9 /ID# 153510

    Kiev, Vinnytsia Oblast, 04112

  • Kyiv Regional Onco Dispensary /ID# 153514

    Kyiv, 04107

  • Poltava Reg Clin Hosp Sklifoso /ID# 153513

    Poltava, 36011

Other trials in Ukraine

Croatia3 sites

  • Duplicate_Klinicki bolnicki centar Osijek /ID# 153623

    Osijek, County of Osijek-Baranja, 31000

  • Clinical Hospital Dubrava /ID# 153515

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 153383

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Finland3 sites

  • Helsinki University Hospital /ID# 155223

    Helsinki, Uusimaa, 00290

  • Tampere University Hospital /ID# 154963

    Tampere, Pirkanmaa, 33520

  • Turku University Hospital /ID# 154964

    Turku, 20520

Other trials in Finland

Poland3 sites

  • SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 153385

    Chorzów, Silesian Voivodeship, 41-500

  • Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym im. Ludwika Rydygiera w /ID# 169846

    Krakow, Lesser Poland Voivodeship, 31-826

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153389

    Wroclaw, Lower Silesian Voivodeship, 50-556

Other trials in Poland

South Korea3 sites

  • Duplicate_Konkuk University Medical Ctr /ID# 153973

    Seoul, Seoul Teugbyeolsi, 05030

  • Seoul National University Hospital /ID# 153675

    Seoul, 03080

  • Samsung Medical Center /ID# 153674

    Seoul, 06351

Other trials in South Korea

Turkey (Türkiye)3 sites

  • Hacettepe University Faculty of Medicine /ID# 202073

    Ankara, 06100

  • Ankara Universitesi Fakultesi /ID# 155200

    Ankara, 06620

  • Ondokuz Mayis Universitesi Tip /ID# 155201

    Samsun, 55139

Other trials in Turkey (Türkiye)

Portugal2 sites

  • Duplicate_Hospital de Braga /ID# 154797

    Braga, 4710-423

  • IPO Porto FG, EPE /ID# 154138

    Porto, 4200-072

Other trials in Portugal

South Africa2 sites

  • University of Pretoria /ID# 153682

    Pretoria, Gauteng, 0001

  • Albert Alberts Stem Cell Transplant Centre /ID# 153684

    Pretoria, Gauteng, 0044

Other trials in South Africa

Denmark1 site

  • Aalborg University Hospital /ID# 154047

    Aalborg, North Denmark, 9000

Other trials in Denmark

Puerto Rico1 site

  • VA Caribbean Healthcare System /ID# 160507

    San Juan, 00921-3201

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed.

Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own.

Read more

This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are >= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants.

In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine.

Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.

Being tested
Azacitidine, Venetoclax, Placebo
Keywords
Acute Myeloid Leukemia, Venetoclax, Treatment Naïve, Azacitidine
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.

  • AzacitidineDrug

    Solution for subcutaneous or intravenous administration.

  • VenetoclaxDrug

    Also called ABT-199

    Tablet

  • PlaceboDrug

    Matching placebo tablet

Study groups in NCT02993523
Study groupRoleWhat they receive
Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2Placebo comparatorParticipants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax-matching placebo, orally, every day (QD), from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, subcutaneously (SC) or intravenously (IV), QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
Receives: Drug: Azacitidine; Drug: Placebo
Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2Active comparatorParticipants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
Receives: Drug: Azacitidine; Drug: Venetoclax
Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2Active comparatorParticipants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
Receives: Drug: Azacitidine; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS is defined as the number of days from the date of randomization to the date of death. Log rank test was used to compare the OS distribution between two treatment arms. Cox regression was used to report the hazard ratio.

    Measured: From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021)

  2. Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)

    CR and CRi was calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count >10^3/ microliter (mcL), platelets >10^5/mcL, red cell transfusion independence, and bone marrow with <5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of ≤10^3/mcL or platelets ≤10^5/mcL. Percentages are rounded off to whole number at the nearest decimal.

    Measured: From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021)

Secondary outcomes (7)

  1. Event-free Survival (EFS)

    EFS will be defined as the number of days from randomization to the date of progressive disease, relapse from CR or CRi, treatment failure or death from any cause.

    Measured: Measured up to 2 years after the last participant is randomized

  2. Global Health Status/Quality of Life (GHS/QoL)

    Improvement in GHS/QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30).

    Measured: Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last subject last visit

  3. Percentage of Participants Achieving Composite Complete Remission (CR or CRi)

    This will be calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count > 10^3/mcL, platelets > 10^5/mcL, red cell transfusion independence, and bone marrow with < 5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of <= 10^3/mcL or platelets <= 10^5/mcL.

    Measured: Up to 6 months after the first 225 participants are randomized

  4. Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR+CRh)

    A response of CRh is defined as Bone marrow with <5% blasts, peripheral blood neutrophil count >0.5*10^3/mcL and peripheral blood platelet count >0.5*10^5/mcL.

    Measured: Measured up to 2 years after the last participant is randomized

  5. Post Baseline Transfusion Independence Rate

    Transfusion Independence is defined as a period of 56 days with no transfusion between first dose of study drug and the last dose of study drug + 30 days. The rate of conversion for red blood cells (RBC) and platelets is defined as percentage of participants being post-baseline transfusion independent from baseline transfusion dependence.

    Measured: Measured up to 2 years after the last participant is randomized

  6. Complete Remission (CR) Rate

    The percentage of participants with complete remission (CR) will be calculated based on the modified IWG criteria for AML.

    Measured: Measured up to 2 years after the last participant is randomized

  7. Fatigue/Quality of Life (QoL)

    Fatigue QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form (SF) 7a global fatigue score

    Measured: Measured at participant's Day 1 of Cycle 1 (each cycle is 28 days) and at Day 1 of every Cycle thereafter for up to 2 years following the last participant last visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2016 (estimated)
  2. Study start2 Feb 2017
  3. Primary completion1 Dec 2021
  4. Study completion15 Jun 2026 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
443 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02993523
Sponsor's protocol ID
M15-656
Other IDs
2016-001466-28, 2016
Acronym
Viale-a
Status last verified
May 2026
First submitted
13 Dec 2016
Last updated
11 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Expanded access
Available

Publications

  • Venditti A, Hou JZ, Fenaux P, Jonas BA, Vrhovac R, Montesinos P, Garcia JS, Rizzieri D, Thirman MJ, Zhang M, Potluri J, Miller C, Dhalla M, Pullarkat V. Outcomes of patients treated with venetoclax plus azacitidine versus azacitidine alone stratified by advanced age and acute myeloid leukemia composite model. Leukemia. 2025 Nov;39(11):2697-2707. doi: 10.1038/s41375-025-02730-3. Epub 2025 Sep 5.

    PubMed 40913104

  • Dohner H, Pratz KW, DiNardo CD, Wei AH, Jonas BA, Pullarkat VA, Thirman MJ, Recher C, Schuh AC, Babu S, Li X, Ku G, Liu Z, Sun Y, Potluri J, Dail M, Chyla B, Pollyea DA. Genetic risk stratification and outcomes among treatment-naive patients with AML treated with venetoclax and azacitidine. Blood. 2024 Nov 21;144(21):2211-2222. doi: 10.1182/blood.2024024944.

    PubMed 39133921

  • Pollyea DA, Pratz KW, Wei AH, Pullarkat V, Jonas BA, Recher C, Babu S, Schuh AC, Dail M, Sun Y, Potluri J, Chyla B, DiNardo CD. Outcomes in Patients with Poor-Risk Cytogenetics with or without TP53 Mutations Treated with Venetoclax and Azacitidine. Clin Cancer Res. 2022 Dec 15;28(24):5272-5279. doi: 10.1158/1078-0432.CCR-22-1183.

    PubMed 36007102

  • Badawi M, Chen X, Marroum P, Suleiman AA, Mensing S, Koenigsdorfer A, Schiele JT, Palenski T, Samineni D, Hoffman D, Menon R, Salem AH. Bioavailability Evaluation of Venetoclax Lower-Strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 mg Tablet. Clin Drug Investig. 2022 Aug;42(8):657-668. doi: 10.1007/s40261-022-01172-4. Epub 2022 Jul 13.

    PubMed 35829925

  • Pratz KW, Chai X, Xie J, Yin L, Nie X, Montez M, Iantuono E, Downs L, Ma E. Cost-Effectiveness Analysis of Venetoclax in Combination with Azacitidine Versus Azacitidine Monotherapy in Patients with Acute Myeloid Leukemia Who are Ineligible for Intensive Chemotherapy: From a US Third Party Payer Perspective. Pharmacoeconomics. 2022 Aug;40(8):777-790. doi: 10.1007/s40273-022-01145-7. Epub 2022 Jun 13.

    PubMed 35696071

  • Konopleva M, Thirman MJ, Pratz KW, Garcia JS, Recher C, Pullarkat V, Kantarjian HM, DiNardo CD, Dail M, Duan Y, Chyla B, Potluri J, Miller CL, Wei AH. Impact of FLT3 Mutation on Outcomes after Venetoclax and Azacitidine for Patients with Treatment-Naive Acute Myeloid Leukemia. Clin Cancer Res. 2022 Jul 1;28(13):2744-2752. doi: 10.1158/1078-0432.CCR-21-3405.

    PubMed 35063965

  • Pollyea DA, DiNardo CD, Arellano ML, Pigneux A, Fiedler W, Konopleva M, Rizzieri DA, Smith BD, Shinagawa A, Lemoli RM, Dail M, Duan Y, Chyla B, Potluri J, Miller CL, Kantarjian HM. Impact of Venetoclax and Azacitidine in Treatment-Naive Patients with Acute Myeloid Leukemia and IDH1/2 Mutations. Clin Cancer Res. 2022 Jul 1;28(13):2753-2761. doi: 10.1158/1078-0432.CCR-21-3467.

    PubMed 35046058

  • Pratz KW, Jonas BA, Pullarkat V, Recher C, Schuh AC, Thirman MJ, Garcia JS, DiNardo CD, Vorobyev V, Fracchiolla NS, Yeh SP, Jang JH, Ozcan M, Yamamoto K, Illes A, Zhou Y, Dail M, Chyla B, Potluri J, Dohner H. Measurable Residual Disease Response and Prognosis in Treatment-Naive Acute Myeloid Leukemia With Venetoclax and Azacitidine. J Clin Oncol. 2022 Mar 10;40(8):855-865. doi: 10.1200/JCO.21.01546. Epub 2021 Dec 15.

    PubMed 34910556

  • DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, Konopleva M, Dohner H, Letai A, Fenaux P, Koller E, Havelange V, Leber B, Esteve J, Wang J, Pejsa V, Hajek R, Porkka K, Illes A, Lavie D, Lemoli RM, Yamamoto K, Yoon SS, Jang JH, Yeh SP, Turgut M, Hong WJ, Zhou Y, Potluri J, Pratz KW. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med. 2020 Aug 13;383(7):617-629. doi: 10.1056/NEJMoa2012971.

    PubMed 32786187

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