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

NCT02993523 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: M15-6562016-001466-28
• Study Type: interventional
• Target: 443
• Locations: 28 countries
• Sites: 166

Brief 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. 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. 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.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Acute Myeloid Leukemia; Venetoclax; Treatment Naïve; Azacitidine

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

• 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.

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

Secondary Outcomes (7)

• Event-free Survival (EFS)

  Measured up to 2 years after the last participant is randomized

• Global Health Status/Quality of Life (GHS/QoL)

  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

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

  Up to 6 months after the first 225 participants are randomized

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

  Measured up to 2 years after the last participant is randomized

• Post Baseline Transfusion Independence Rate

  Measured up to 2 years after the last participant is randomized

Study Arms (3)

Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2

PLACEBO COMPARATOR

Participants 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).

Drug: Azacitidine; Drug: Placebo

Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2

ACTIVE COMPARATOR

Participants 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).

Drug: Azacitidine; Drug: Venetoclax

Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2

ACTIVE COMPARATOR

Participants 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).

Drug: Azacitidine; Drug: Venetoclax

Interventions

Azacitidine DRUG

Solution for subcutaneous or intravenous administration.

Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2; Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2; Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2

Venetoclax DRUG

Tablet

Also known as: ABT-199

Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2; Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2

Placebo DRUG

Matching placebo tablet

Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• a. \>= 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:
• to 2 for Participants \>= 75 years of age or
• 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
• i. Participants who are \< 75 years of age may have a bilirubin of \<= 3.0 x ULN
• Female participants must be either postmenopausal defined as:

You may not qualify if:

• 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.
• Participant has the following:
• a. 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.

Sponsors & Collaborators

• AbbVie: lead
• Genentech, Inc.: collaborator

Study Sites (172)

City of Hope /ID# 154105

Duarte, California, 91010, United States

Location

University of California, Los Angeles /ID# 154107

Los Angeles, California, 90095, United States

Location

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

Sacramento, California, 95817, United States

Location

Emory Midtown Infectious Disease Clinic /ID# 162534

Atlanta, Georgia, 30322, United States

Location

Northwestern University Feinberg School of Medicine /ID# 201133

Chicago, Illinois, 60611-2927, United States

Location

University of Chicago Medicine /ID# 154108

Chicago, Illinois, 60637-1426, United States

Location

Fort Wayne Medical Oncology /ID# 157190

Fort Wayne, Indiana, 46804, United States

Location

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

Topeka, Kansas, 66606, United States

Location

Norton Cancer Institute /ID# 154992

Louisville, Kentucky, 40202-3700, United States

Location

EMMC Cancer Care /ID# 154991

Brewer, Maine, 04412, United States

Location

Johns Hopkins University /ID# 154104

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital /ID# 200752

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center /ID# 201155

Boston, Massachusetts, 02215-5400, United States

Location

Dana-Farber Cancer Institute /ID# 167009

Boston, Massachusetts, 02215, United States

Location

Sepctrum Health Medical Center /ID# 159522

Grand Rapids, Michigan, 49503, United States

Location

Columbia Univ Medical Center /ID# 154101

New York, New York, 10032-3725, United States

Location

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

New York, New York, 10065-6007, United States

Location

Duke Cancer Center /ID# 154106

Durham, North Carolina, 27710-3000, United States

Location

University of Pittsburgh MC /ID# 154102

Pittsburgh, Pennsylvania, 15260, United States

Location

Tennessee Oncology-Nashville Centennial /ID# 200854

Nashville, Tennessee, 37203-1632, United States

Location

University of Texas MD Anderson Cancer Center /ID# 154100

Houston, Texas, 77030, United States

Location

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

Temple, Texas, 76508-0001, United States

Location

University of Utah /ID# 157192

Salt Lake City, Utah, 84112-5500, United States

Location

University Of Vermont Medical /ID# 157196

Burlington, Vermont, 05405, United States

Location

Princess Alexandra Hospital /ID# 154272

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital /ID# 154271

Adelaide, South Australia, 5000, Australia

Location

Alfred Health /ID# 154275

Melbourne, Victoria, 3004, Australia

Location

St Vincent's Hospital Melbourne /ID# 155094

Melbourne, Victoria, 3065, Australia

Location

The Royal Melbourne Hospital /ID# 155095

Parkville, Victoria, 3050, Australia

Location

Sir Charles Gairdner Hospital /ID# 163924

Nedlands, Western Australia, 6009, Australia

Location

Royal Perth Hospital /ID# 154274

Perth, Western Australia, 6000, Australia

Location

Universitaetsklinikum St. Poelten /ID# 167436

Sankt Pölten, Lower Austria, 3100, Austria

Location

Medizinische Universitaet Graz /ID# 157882

Graz, Styria, 8036, Austria

Location

Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888

Linz, Upper Austria, 4010, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen /ID# 154885

Linz, Upper Austria, 4010, Austria

Location

Duplicate_Landeskrankenhaus Salzburg /ID# 169719

Salzburg, 5020, Austria

Location

Hanusch Krankenhaus /ID# 155676

Vienna, 1140, Austria

Location

UZ Brussel /ID# 153393

Jette, Brussels Capital, 1090, Belgium

Location

UCL Saint-Luc /ID# 153391

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

Location

UZ Gent /ID# 153392

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

AZ Sint-Jan Brugge /ID# 154041

Bruges, 8000, Belgium

Location

Hospital de Clinicas de Porto Alegre /ID# 157779

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

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

Ribeirão Preto, São Paulo, 14051-140, Brazil

Location

Instituto de Ensino e Pesquisa São Lucas /ID# 157778

São Paulo, São Paulo, 01236-030, Brazil

Location

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

São Paulo, São Paulo, 01246-000, Brazil

Location

Tom Baker Cancer Centre /ID# 159645

Calgary, Alberta, T2N 4N2, Canada

Location

St. Paul's Hospital /ID# 159644

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Juravinski Cancer Centre /ID# 153650

Hamilton, Ontario, L8V 1C3, Canada

Location

Ottawa Hospital Research Institute /ID# 153541

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre /ID# 153651

Toronto, Ontario, M5G 2M9, Canada

Location

Fujian Medical University Union Hospital /ID# 167314

Fuzhou, Fujian, 350001, China

Location

Nanfang Hospital of Southern Medical University /ID# 170148

Guangzhou, Guangdong, 510515, China

Location

The Second Hospital of Hebei Medical University /ID# 167316

Shijiazhuang, Hebei, 050000, China

Location

Henan Cancer Hospital /ID# 167320

Zhengzhou, Henan, 450008, China

Location

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

Wuhan, Hubei, 430022, China

Location

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

Wuhan, Hubei, 430022, China

Location

Jiangsu Province Hospital /ID# 167489

Nanjing, Jiangsu, 210029, China

Location

The First Hospital of Jilin University /ID# 167490

Changchun, Jilin, 130021, China

Location

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

Shanghai, Shanghai Municipality, 200065, China

Location

West China Hospital, Sichuan University /ID# 167492

Chengdu, Sichuan, 610041, China

Location

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

Tianjin, Tianjin Municipality, 300020, China

Location

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

Hangzhou, Zhejiang, 310006, China

Location

Qilu Hospital of Shandong University /ID# 167485

Jinan, 250012, China

Location

Clinical Hospital Dubrava /ID# 153515

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Zagreb /ID# 153383

Zagreb, City of Zagreb, 10000, Croatia

Location

Duplicate_Klinicki bolnicki centar Osijek /ID# 153623

Osijek, County of Osijek-Baranja, 31000, Croatia

Location

Fakultni Nemocnice Brno /ID# 154019

Brno, 625 00, Czechia

Location

Fakultni nemocnice Hradec Kralove /ID# 154021

Hradec Králové, 500 05, Czechia

Location

Fakultni nemocnice Ostrava /ID# 154017

Ostrava, 708 52, Czechia

Location

Fakultni nemocnice Plzen /ID# 154018

Pilsen, 305 99, Czechia

Location

Aalborg University Hospital /ID# 154047

Aalborg, North Denmark, 9000, Denmark

Location

Tampere University Hospital /ID# 154963

Tampere, Pirkanmaa, 33520, Finland

Location

Helsinki University Hospital /ID# 155223

Helsinki, Uusimaa, 00290, Finland

Location

Turku University Hospital /ID# 154964

Turku, 20520, Finland

Location

CHU Bordeaux - Hopital Haut Leveque /ID# 153789

Pessac, Gironde, 33604, France

Location

Chu Angers /Id# 153792

Angers, 49933, France

Location

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

Paris, 75010, France

Location

IUCT Oncopole /ID# 153788

Toulouse, 31059, France

Location

Universitaetsklinikum Ulm /ID# 153054

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Universitaetsklinikum Frankfurt /ID# 153060

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Muenster /ID# 153059

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitaetsklinikum Halle (Saale) /ID# 153058

Halle, 06120, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 153056

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover /ID# 153055

Hanover, 30625, Germany

Location

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

Szeged, Csongrád megye, 6725, Hungary

Location

Debreceni Egyetem Klinikai Kozpont /ID# 153814

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

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

Nyíregyháza, Nyiregyhaza, 4400, Hungary

Location

Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813

Kaposvár, Somogy County, 7400, Hungary

Location

Semmelweis Egyetem /ID# 153816

Budapest, 1085, Hungary

Location

Duplicate_Semmelweis Egyetem /ID# 153815

Budapest, 1088, Hungary

Location

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

Budapest, 1097, Hungary

Location

The Chaim Sheba Medical Center /ID# 154173

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 154175

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Assaf Harofeh Medical Center /ID# 158063

Be’er Ya‘aqov, 70300, Israel

Location

Rambam Health Care Campus /ID# 154174

Haifa, 3109601, Israel

Location

Hadassah /ID# 154172

Jerusalem, 91120, Israel

Location

Rabin Medical Center /ID# 154176

Petah Tikva, 4941492, Israel

Location

Presidio Ospedaliero Vito Fazzi /ID# 170837

Lecce, Apulia, 73100, Italy

Location

Fondazione PTV Policlinico Tor Vergata /ID# 152881

Rome, Roma, 00133, Italy

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 171220

Ancona, 60126, Italy

Location

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

Bergamo, 24127, Italy

Location

IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 152883

Bologna, 40138, Italy

Location

Ospedale Policlinico San Martino /ID# 158104

Genova, 16132, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882

Milan, 20122, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 152879

Naples, 80131, Italy

Location

Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 152877

Reggio Calabria, 89124, Italy

Location

Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 152876

Rome, 00189, Italy

Location

Aichi Cancer Center Hospital /ID# 200824

Nagoya, Aichi-ken, 464-8681, Japan

Location

University of Fukui Hospital /ID# 167432

Yoshida-gun, Fukui, 910-1193, Japan

Location

National Hospital Organization Kyushu Cancer Center /ID# 201111

Fukuoka, Fukuoka, 811-1395, Japan

Location

Kyushu University Hospital /ID# 169095

Fukuoka, Fukuoka, 812-8582, Japan

Location

Gunmaken Saiseikai Maebashi Hospital /ID# 168316

Maebashi, Gunma, 371-0821, Japan

Location

National Hospital Organization Mito Medical Center /ID# 168219

Higashi, Ibaraki, 311-3193, Japan

Location

Hitachi General Hospital /ID# 201109

Hitachi-shi, Ibaraki, 317-0077, Japan

Location

Duplicate_Kyoto Prefectural University of Medicine /ID# 167661

Kyoto, Kyoto, 602-8566, Japan

Location

Tohoku University Hospital /ID# 169259

Sendai, Miyagi, 9808574, Japan

Location

Nagasaki University Hospital /ID# 168632

Nagasaki, Nagasaki, 852-8501, Japan

Location

Okayama University Hospital /ID# 204124

Okayama, Okayama-ken, 700-8558, Japan

Location

Osaka Metropolitan University Hospital /ID# 169055

Osaka, Osaka, 545-8586, Japan

Location

Duplicate_Kindai University Hospital /ID# 167662

Osaka-sayama-shi, Osaka, 589-8511, Japan

Location

Saitama Medical University International Medical Center /ID# 167814

Hidaka-shi, Saitama, 350-1298, Japan

Location

Juntendo University Hospital /ID# 168309

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

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

Bunkyo-ku, Tokyo, 113-8677, Japan

Location

The Jikei University Daisan Hospital /ID# 168745

Komae-shi, Tokyo, 201-8601, Japan

Location

NTT Medical Center Tokyo /ID# 167975

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Yamagata University Hospital /ID# 167634

Yamagata, Yamagata, 990-9585, Japan

Location

Akershus universitetssykehus /ID# 154279

Nordlenangen, Akershus, 1474, Norway

Location

Drammen Sykehus /ID# 154280

Drammen, Buskerud, 3004, Norway

Location

Haukeland University Hospital /ID# 154281

Bergen, Hordaland, 5021, Norway

Location

Sykehuset Ostfold Kalnes /ID# 157755

Grålum, 1714, Norway

Location

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

Krakow, Lesser Poland Voivodeship, 31-826, Poland

Location

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

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 153385

Chorzów, Silesian Voivodeship, 41-500, Poland

Location

Duplicate_Hospital de Braga /ID# 154797

Braga, 4710-423, Portugal

Location

IPO Porto FG, EPE /ID# 154138

Porto, 4200-072, Portugal

Location

VA Caribbean Healthcare System /ID# 160507

San Juan, 00921-3201, Puerto Rico

Location

Kuzbass Regional Clinical Hospital /ID# 157461

Kemerovo, Kemerovo Oblast, 650099, Russia

Location

Moscow State budget healthcare /ID# 155738

Moscow, Moscow, 125284, Russia

Location

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

Nizhny Novgorod, Nizhny Novgorod Oblast, 603126, Russia

Location

Duplicate_Regional Oncology Dispensary /ID# 153264

Penza, Penza Oblast, 440071, Russia

Location

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

Ryazan, Ryazan Oblast, 390039, Russia

Location

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

Saratov, Saratov Oblast, 410012, Russia

Location

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

Moscow, 125167, Russia

Location

Samara State Medical University /ID# 157462

Samara, 443099, Russia

Location

University of Pretoria /ID# 153682

Pretoria, Gauteng, 0001, South Africa

Location

Albert Alberts Stem Cell Transplant Centre /ID# 153684

Pretoria, Gauteng, 0044, South Africa

Location

Duplicate_Konkuk University Medical Ctr /ID# 153973

Seoul, Seoul Teugbyeolsi, 05030, South Korea

Location

Seoul National University Hospital /ID# 153675

Seoul, 03080, South Korea

Location

Samsung Medical Center /ID# 153674

Seoul, 06351, South Korea

Location

Hospital Universitario de Navarra /ID# 153254

Pamplona, Navarre, 31008, Spain

Location

Hospital Clinic de Barcelona /ID# 153255

Barcelona, 08036, Spain

Location

Hospital Santa Creu i Sant Pau /ID# 153193

Barcelona, 08041, Spain

Location

Hospital Universitario de la Princesa /ID# 153256

Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Maranon /ID# 153260

Madrid, 28007, Spain

Location

Hospital Universitario 12 de Octubre /ID# 153258

Madrid, 28041, Spain

Location

Hospital Universitario Virgen de la Victoria /ID# 153257

Málaga, 29010, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 153259

Valencia, 46026, Spain

Location

Akademiska Sjukhuset /ID# 153034

Uppsala, Uppsala County, 751 85, Sweden

Location

Uddevalla sjukhus /ID# 156875

Uddevalla, Västra Götaland County, 451 80, Sweden

Location

Dup_VO Hematologi /ID# 153174

Lund, 221 85, Sweden

Location

Karolinska University Hospital /ID# 170003

Stockholm, 171 76, Sweden

Location

Changhua Christian Hospital /ID# 153899

Changhua, Changhua County, 50006, Taiwan

Location

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

Kaohsiung City, 807, Taiwan

Location

China Medical University Hospital /ID# 153904

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital /ID# 153900

Taipei, 100, Taiwan

Location

Hacettepe University Faculty of Medicine /ID# 202073

Ankara, 06100, Turkey (Türkiye)

Location

Ankara Universitesi Fakultesi /ID# 155200

Ankara, 06620, Turkey (Türkiye)

Location

Ondokuz Mayis Universitesi Tip /ID# 155201

Samsun, 55139, Turkey (Türkiye)

Location

Kyiv city clinical hospital #9 /ID# 153510

Kiev, Vinnytsia Oblast, 04112, Ukraine

Location

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

Dnipro, 49102, Ukraine

Location

Kyiv Regional Onco Dispensary /ID# 153514

Kyiv, 04107, Ukraine

Location

Poltava Reg Clin Hosp Sklifoso /ID# 153513

Poltava, 36011, Ukraine

Location

Related Publications (9)

• 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.

  PMID: 40913104 DERIVED

• 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.

  PMID: 39133921 DERIVED

• 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.

  PMID: 36007102 DERIVED

• 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.

  PMID: 35829925 DERIVED

• 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.

  PMID: 35696071 DERIVED

• 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.

  PMID: 35063965 DERIVED

• 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.

  PMID: 35046058 DERIVED

• 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.

  PMID: 34910556 DERIVED

• 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.

  PMID: 32786187 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 15, 2016
• Study Start: February 2, 2017
• Primary Completion: December 1, 2021
• Study Completion: November 24, 2025
• Last Updated: May 15, 2026
• Results First Posted: January 27, 2023

Record last verified: 2026-05

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: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

PT (2); DK (1); UA (4); FR (4); KR (3); NO (4); JP (19); SE (4); TU (3); CA (5); RU (8); BR (4); DE (6); ZA (2); PL (3); CR (3); IT (10); HU (7); CZ (4); CN (13); TW (4); ES (8); US (24); IL (6); FI (3); BE (4); PR (1); AU (7)