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

NCT ID: NCT02993523

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 443 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-02
• Study Completion Date: 2026-01-23

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

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).

Group Type: PLACEBO_COMPARATOR

Azacitidine

Intervention Type: DRUG

Solution for subcutaneous or intravenous administration.

Placebo

Intervention Type: DRUG

Matching placebo tablet

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

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).

Group Type: ACTIVE_COMPARATOR

Azacitidine

Intervention Type: DRUG

Solution for subcutaneous or intravenous administration.

Venetoclax

Intervention Type: DRUG

Tablet

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

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).

Group Type: ACTIVE_COMPARATOR

Azacitidine

Intervention Type: DRUG

Solution for subcutaneous or intravenous administration.

Venetoclax

Intervention Type: DRUG

Tablet

Interventions

Azacitidine

Solution for subcutaneous or intravenous administration.

Intervention Type: DRUG

Venetoclax

Tablet

Intervention Type: DRUG

Placebo

Matching placebo tablet

Intervention Type: DRUG

Other Intervention Names

ABT-199

Eligibility Criteria

Inclusion Criteria

• 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:

1. 0 to 2 for Participants >= 75 years of age or

2. 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:

1. aspartate aminotransferase (AST) <= 3.0 x ULN*

2. alanine aminotransferase (ALT) <= 3.0 x ULN*

3. 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:

1. Age > 55 years with no menses for 12 or more months without an alternative medical cause.

2. 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

3. Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); or

4. 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:

1. At Screening with a serum sample obtained within 14 days prior to the first study drug administration, and

2. 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.

Exclusion Criteria

• Participant has received treatment with the following:

1. A hypomethylating agent, venetoclax and/or chemo therapeutic agent for Myelodysplastic syndrome (MDS).

2. Chimeric Antigen Receptor (CAR)-T cell therapy.

3. Experimental therapies for MDS or Acute Myeloid Leukemia (AML).

4. 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.
• 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:

1. Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;

2. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;

3. 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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

City of Hope /ID# 154105

Duarte, California, United States

University of California, Los Angeles /ID# 154107

Los Angeles, California, United States

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

Sacramento, California, United States

Emory Midtown Infectious Disease Clinic /ID# 162534

Atlanta, Georgia, United States

Northwestern University Feinberg School of Medicine /ID# 201133

Chicago, Illinois, United States

University of Chicago Medicine /ID# 154108

Chicago, Illinois, United States

Fort Wayne Medical Oncology /ID# 157190

Fort Wayne, Indiana, United States

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

Topeka, Kansas, United States

Norton Cancer Institute /ID# 154992

Louisville, Kentucky, United States

EMMC Cancer Care /ID# 154991

Brewer, Maine, United States

Johns Hopkins University /ID# 154104

Baltimore, Maryland, United States

Massachusetts General Hospital /ID# 200752

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center /ID# 201155

Boston, Massachusetts, United States

Dana-Farber Cancer Institute /ID# 167009

Boston, Massachusetts, United States

Sepctrum Health Medical Center /ID# 159522

Grand Rapids, Michigan, United States

Columbia Univ Medical Center /ID# 154101

New York, New York, United States

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

New York, New York, United States

Duke Cancer Center /ID# 154106

Durham, North Carolina, United States

University of Pittsburgh MC /ID# 154102

Pittsburgh, Pennsylvania, United States

Tennessee Oncology-Nashville Centennial /ID# 200854

Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center /ID# 154100

Houston, Texas, United States

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

Temple, Texas, United States

University of Utah /ID# 157192

Salt Lake City, Utah, United States

University Of Vermont Medical /ID# 157196

Burlington, Vermont, United States

Princess Alexandra Hospital /ID# 154272

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital /ID# 154271

Adelaide, South Australia, Australia

Alfred Health /ID# 154275

Melbourne, Victoria, Australia

St Vincent's Hospital Melbourne /ID# 155094

Melbourne, Victoria, Australia

The Royal Melbourne Hospital /ID# 155095

Parkville, Victoria, Australia

Sir Charles Gairdner Hospital /ID# 163924

Nedlands, Western Australia, Australia

Royal Perth Hospital /ID# 154274

Perth, Western Australia, Australia

Universitaetsklinikum St. Poelten /ID# 167436

Sankt Pölten, Lower Austria, Austria

Medizinische Universitaet Graz /ID# 157882

Graz, Styria, Austria

Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888

Linz, Upper Austria, Austria

Ordensklinikum Linz GmbH Elisabethinen /ID# 154885

Linz, Upper Austria, Austria

Duplicate_Landeskrankenhaus Salzburg /ID# 169719

Salzburg, , Austria

Hanusch Krankenhaus /ID# 155676

Vienna, , Austria

UZ Brussel /ID# 153393

Jette, Brussels Capital, Belgium

UCL Saint-Luc /ID# 153391

Woluwe-Saint-Lambert, Brussels Capital, Belgium

UZ Gent /ID# 153392

Ghent, Oost-Vlaanderen, Belgium

AZ Sint-Jan Brugge /ID# 154041

Bruges, , Belgium

Hospital de Clinicas de Porto Alegre /ID# 157779

Porto Alegre, Rio Grande do Sul, Brazil

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

Ribeirão Preto, São Paulo, Brazil

Instituto de Ensino e Pesquisa São Lucas /ID# 157778

São Paulo, São Paulo, Brazil

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

São Paulo, São Paulo, Brazil

Tom Baker Cancer Centre /ID# 159645

Calgary, Alberta, Canada

St. Paul's Hospital /ID# 159644

Vancouver, British Columbia, Canada

Juravinski Cancer Centre /ID# 153650

Hamilton, Ontario, Canada

Ottawa Hospital Research Institute /ID# 153541

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre /ID# 153651

Toronto, Ontario, Canada

Fujian Medical University Union Hospital /ID# 167314

Fuzhou, Fujian, China

Nanfang Hospital of Southern Medical University /ID# 170148

Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University /ID# 167316

Shijiazhuang, Hebei, China

Henan Cancer Hospital /ID# 167320

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

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

Wuhan, Hubei, China

Jiangsu Province Hospital /ID# 167489

Nanjing, Jiangsu, China

The First Hospital of Jilin University /ID# 167490

Changchun, Jilin, China

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

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University /ID# 167492

Chengdu, Sichuan, China

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

Tianjin, Tianjin Municipality, China

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

Hangzhou, Zhejiang, China

Qilu Hospital of Shandong University /ID# 167485

Jinan, , China

Clinical Hospital Dubrava /ID# 153515

Zagreb, City of Zagreb, Croatia

Klinicki bolnicki centar Zagreb /ID# 153383

Zagreb, City of Zagreb, Croatia

Duplicate_Klinicki bolnicki centar Osijek /ID# 153623

Osijek, County of Osijek-Baranja, Croatia

Fakultni Nemocnice Brno /ID# 154019

Brno, , Czechia

Fakultni nemocnice Hradec Kralove /ID# 154021

Hradec Králové, , Czechia

Fakultni nemocnice Ostrava /ID# 154017

Ostrava, , Czechia

Fakultni nemocnice Plzen /ID# 154018

Pilsen, , Czechia

Aalborg University Hospital /ID# 154047

Aalborg, North Denmark, Denmark

Tampere University Hospital /ID# 154963

Tampere, Pirkanmaa, Finland

Helsinki University Hospital /ID# 155223

Helsinki, Uusimaa, Finland

Turku University Hospital /ID# 154964

Turku, , Finland

CHU Bordeaux - Hopital Haut Leveque /ID# 153789

Pessac, Gironde, France

Chu Angers /Id# 153792

Angers, , France

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

Paris, , France

IUCT Oncopole /ID# 153788

Toulouse, , France

Universitaetsklinikum Ulm /ID# 153054

Ulm, Baden-Wurttemberg, Germany

Universitaetsklinikum Frankfurt /ID# 153060

Frankfurt am Main, Hesse, Germany

Universitaetsklinikum Muenster /ID# 153059

Münster, North Rhine-Westphalia, Germany

Universitaetsklinikum Halle (Saale) /ID# 153058

Halle, , Germany

Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 153056

Hamburg, , Germany

Medizinische Hochschule Hannover /ID# 153055

Hanover, , Germany

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

Szeged, Csongrád megye, Hungary

Debreceni Egyetem Klinikai Kozpont /ID# 153814

Debrecen, Hajdú-Bihar, Hungary

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

Nyíregyháza, Nyiregyhaza, Hungary

Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813

Kaposvár, Somogy County, Hungary

Semmelweis Egyetem /ID# 153816

Budapest, , Hungary

Duplicate_Semmelweis Egyetem /ID# 153815

Budapest, , Hungary

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

Budapest, , Hungary

The Chaim Sheba Medical Center /ID# 154173

Ramat Gan, Tel Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 154175

Tel Aviv, Tel Aviv, Israel

Assaf Harofeh Medical Center /ID# 158063

Be’er Ya‘aqov, , Israel

Rambam Health Care Campus /ID# 154174

Haifa, , Israel

Hadassah /ID# 154172

Jerusalem, , Israel

Rabin Medical Center /ID# 154176

Petah Tikva, , Israel

Presidio Ospedaliero Vito Fazzi /ID# 170837

Lecce, Apulia, Italy

Fondazione PTV Policlinico Tor Vergata /ID# 152881

Rome, Roma, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 171220

Ancona, , Italy

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

Bergamo, , Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 152883

Bologna, , Italy

Ospedale Policlinico San Martino /ID# 158104

Genova, , Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882

Milan, , Italy

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 152879

Napoli, , Italy

Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 152877

Reggio Calabria, , Italy

Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 152876

Rome, , Italy

Aichi Cancer Center Hospital /ID# 200824

Nagoya, Aichi-ken, Japan

University of Fukui Hospital /ID# 167432

Yoshida-gun, Fukui, Japan

National Hospital Organization Kyushu Cancer Center /ID# 201111

Fukuoka, Fukuoka, Japan

Kyushu University Hospital /ID# 169095

Fukuoka, Fukuoka, Japan

Gunmaken Saiseikai Maebashi Hospital /ID# 168316

Maebashi, Gunma, Japan

National Hospital Organization Mito Medical Center /ID# 168219

Higashi, Ibaraki, Japan

Hitachi General Hospital /ID# 201109

Hitachi-shi, Ibaraki, Japan

Duplicate_Kyoto Prefectural University of Medicine /ID# 167661

Kyoto, Kyoto, Japan

Tohoku University Hospital /ID# 169259

Sendai, Miyagi, Japan

Nagasaki University Hospital /ID# 168632

Nagasaki, Nagasaki, Japan

Okayama University Hospital /ID# 204124

Okayama, Okayama-ken, Japan

Osaka Metropolitan University Hospital /ID# 169055

Osaka, Osaka, Japan

Duplicate_Kindai University Hospital /ID# 167662

Osaka-sayama-shi, Osaka, Japan

Saitama Medical University International Medical Center /ID# 167814

Hidaka-shi, Saitama, Japan

Juntendo University Hospital /ID# 168309

Bunkyo-ku, Tokyo, Japan

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

Bunkyo-ku, Tokyo, Japan

The Jikei University Daisan Hospital /ID# 168745

Komae-shi, Tokyo, Japan

NTT Medical Center Tokyo /ID# 167975

Shinagawa-ku, Tokyo, Japan

Yamagata University Hospital /ID# 167634

Yamagata, Yamagata, Japan

Akershus universitetssykehus /ID# 154279

Nordlenangen, Akershus, Norway

Drammen Sykehus /ID# 154280

Drammen, Buskerud, Norway

Haukeland University Hospital /ID# 154281

Bergen, Hordaland, Norway

Sykehuset Ostfold Kalnes /ID# 157755

Grålum, , Norway

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

Krakow, Lesser Poland Voivodeship, Poland

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

Wroclaw, Lower Silesian Voivodeship, Poland

SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 153385

Chorzów, Silesian Voivodeship, Poland

Duplicate_Hospital de Braga /ID# 154797

Braga, , Portugal

IPO Porto FG, EPE /ID# 154138

Porto, , Portugal

VA Caribbean Healthcare System /ID# 160507

San Juan, , Puerto Rico

Kuzbass Regional Clinical Hospital /ID# 157461

Kemerovo, Kemerovo Oblast, Russia

Moscow State budget healthcare /ID# 155738

Moscow, Moscow, Russia

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

Nizhny Novgorod, Nizhny Novgorod Oblast, Russia

Duplicate_Regional Oncology Dispensary /ID# 153264

Penza, Penza Oblast, Russia

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

Ryazan, Ryazan Oblast, Russia

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

Saratov, Saratov Oblast, Russia

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

Moscow, , Russia

Samara State Medical University /ID# 157462

Samara, , Russia

University of Pretoria /ID# 153682

Pretoria, Gauteng, South Africa

Albert Alberts Stem Cell Transplant Centre /ID# 153684

Pretoria, Gauteng, South Africa

Duplicate_Konkuk University Medical Ctr /ID# 153973

Seoul, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital /ID# 153675

Seoul, , South Korea

Samsung Medical Center /ID# 153674

Seoul, , South Korea

Hospital Universitario de Navarra /ID# 153254

Pamplona, Navarre, Spain

Hospital Clinic de Barcelona /ID# 153255

Barcelona, , Spain

Hospital Santa Creu i Sant Pau /ID# 153193

Barcelona, , Spain

Hospital Universitario de la Princesa /ID# 153256

Madrid, , Spain

Hospital General Universitario Gregorio Maranon /ID# 153260

Madrid, , Spain

Hospital Universitario 12 de Octubre /ID# 153258

Madrid, , Spain

Hospital Universitario Virgen de la Victoria /ID# 153257

Málaga, , Spain

Hospital Universitario y Politecnico La Fe /ID# 153259

Valencia, , Spain

Akademiska Sjukhuset /ID# 153034

Uppsala, Uppsala County, Sweden

Uddevalla sjukhus /ID# 156875

Uddevalla, Västra Götaland County, Sweden

Dup_VO Hematologi /ID# 153174

Lund, , Sweden

Karolinska University Hospital /ID# 170003

Stockholm, , Sweden

Changhua Christian Hospital /ID# 153899

Changhua, Changhua County, Taiwan

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

Kaohsiung City, , Taiwan

China Medical University Hospital /ID# 153904

Taichung, , Taiwan

National Taiwan University Hospital /ID# 153900

Taipei, , Taiwan

Hacettepe University Faculty of Medicine /ID# 202073

Ankara, , Turkey (Türkiye)

Ankara Universitesi Fakultesi /ID# 155200

Ankara, , Turkey (Türkiye)

Ondokuz Mayis Universitesi Tip /ID# 155201

Samsun, , Turkey (Türkiye)

Kyiv city clinical hospital #9 /ID# 153510

Kiev, Vinnytsia Oblast, Ukraine

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

Dnipro, , Ukraine

Kyiv Regional Onco Dispensary /ID# 153514

Kyiv, , Ukraine

Poltava Reg Clin Hosp Sklifoso /ID# 153513

Poltava, , Ukraine

Countries

United States; Australia; Austria; Belgium; Brazil; Canada; China; Croatia; Czechia; Denmark; Finland; France; Germany; Hungary; Israel; Italy; Japan; Norway; Poland; Portugal; Puerto Rico; Russia; South Africa; South Korea; Spain; Sweden; Taiwan; Turkey (Türkiye); Ukraine

References

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 Sep 5. doi: 10.1038/s41375-025-02730-3. Online ahead of print.

Reference Type: DERIVED

PMID: 40913104 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39133921 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36007102 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35829925 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35696071 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35063965 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35046058 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34910556 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32786187 (View on PubMed)

Provided Documents

Document Type: Study Protocol

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Document Type: Statistical Analysis Plan

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Related Links

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Related Info

Other Identifiers

2016-001466-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M15-656

Identifier Type: -

Identifier Source: org_study_id