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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 (Viale-a)

Primary Purpose

Acute Myeloid Leukemia (AML)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Azacitidine
Venetoclax
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring Acute Myeloid Leukemia, Venetoclax, Treatment Naïve, Azacitidine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Subjects 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 FSH level > 40 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 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 HBV DNA 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.)

Sites / Locations

  • City of Hope /ID# 154105
  • University of California, Los Angeles /ID# 154107
  • University of California, Davis Comprehensive Cancer Center /ID# 162725
  • Emory Midtown Infectious Disease Clinic /ID# 162534
  • Northwestern University Feinberg School of Medicine /ID# 201133
  • University of Chicago Medicine /ID# 154108
  • Fort Wayne Medical Oncology /ID# 157190
  • Cotton-O'Neil Clinical Res Ctr /ID# 155136
  • Norton Cancer Institute /ID# 154992
  • EMMC Cancer Care /ID# 154991
  • Johns Hopkins University /ID# 154104
  • Massachusetts General Hospital /ID# 200752
  • Beth Israel Deaconess Medical Center /ID# 201155
  • Dana-Farber Cancer Institute /ID# 167009
  • Sepctrum Health Medical Center /ID# 159522
  • Columbia Univ Medical Center /ID# 154101
  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077
  • Duke Cancer Center /ID# 154106
  • University of Pittsburgh MC /ID# 154102
  • Tennessee Oncology-Nashville Centennial /ID# 200854
  • University of Texas MD Anderson Cancer Center /ID# 154100
  • Baylor Scott & White Medical Center- Temple /ID# 157191
  • University of Utah /ID# 157192
  • University Of Vermont Medical /ID# 157196
  • Princess Alexandra Hospital /ID# 154272
  • Royal Adelaide Hospital /ID# 154271
  • Alfred Health /ID# 154275
  • St Vincent's Hospital Melbourne /ID# 155094
  • The Royal Melbourne Hospital /ID# 155095
  • Sir Charles Gairdner Hospital /ID# 163924
  • Royal Perth Hospital /ID# 154274
  • Universitaetsklinikum St. Poelten /ID# 167436
  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888
  • Ordensklinikum Linz GmbH Elisabethinen /ID# 154885
  • Medizinische Universitaet Graz /ID# 157882
  • Duplicate_Landeskrankenhaus Salzburg /ID# 169719
  • Hanusch Krankenhaus /ID# 155676
  • UZ Brussel /ID# 153393
  • UCL Saint-Luc /ID# 153391
  • UZ Gent /ID# 153392
  • AZ Sint-Jan Brugge /ID# 154041
  • Hospital de Clinicas de Porto Alegre /ID# 157779
  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 153099
  • Instituto de Ensino e Pesquisa São Lucas /ID# 157778
  • Instituto do Câncer do Estado de São Paulo - ICESP /ID# 153095
  • Tom Baker Cancer Centre /ID# 159645
  • St. Paul's Hospital /ID# 159644
  • Juravinski Cancer Centre /ID# 153650
  • Ottawa Hospital Research Institute /ID# 153541
  • Princess Margaret Cancer Centre /ID# 153651
  • Fujian Medical University Union Hospital /ID# 167314
  • Nanfang Hospital of Southern Medical University /ID# 170148
  • The Second Hospital of Hebei Medical University /ID# 167316
  • Henan Cancer Hospital /ID# 167320
  • Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167315
  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167493
  • Jiangsu Province Hospital /ID# 167489
  • The First Hospital of Jilin University /ID# 167490
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 167318
  • West China Hospital, Sichuan University /ID# 167492
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 167487
  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 167317
  • Qilu Hospital of Shandong University /ID# 167485
  • Clinical Hospital Dubrava /ID# 153515
  • Klinicki bolnicki centar Zagreb /ID# 153383
  • Duplicate_Klinicki bolnicki centar Osijek /ID# 153623
  • Fakultni Nemocnice Brno /ID# 154019
  • Fakultni nemocnice Hradec Kralove /ID# 154021
  • Fakultni nemocnice Ostrava /ID# 154017
  • Fakultni nemocnice Plzen /ID# 154018
  • Aalborg University Hospital /ID# 154047
  • Tampere University Hospital /ID# 154963
  • Helsinki University Hospital /ID# 155223
  • Turku University Hospital /ID# 154964
  • CHU Bordeaux - Hopital Haut Leveque /ID# 153789
  • Chu Angers /Id# 153792
  • AP-HP - Hopital Saint-Louis /ID# 153787
  • IUCT Oncopole /ID# 153788
  • Universitaetsklinikum Ulm /ID# 153054
  • Universitaetsklinikum Frankfurt /ID# 153060
  • Universitaetsklinikum Muenster /ID# 153059
  • Universitaetsklinikum Halle (Saale) /ID# 153058
  • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 153056
  • Medizinische Hochschule Hannover /ID# 153055
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 153812
  • Debreceni Egyetem Klinikai Kozpont /ID# 153814
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 169854
  • Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813
  • Semmelweis Egyetem /ID# 153816
  • Duplicate_Semmelweis Egyetem /ID# 153815
  • Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 158990
  • The Chaim Sheba Medical Center /ID# 154173
  • Tel Aviv Sourasky Medical Center /ID# 154175
  • Assaf Harofeh Medical Center /ID# 158063
  • Rambam Health Care Campus /ID# 154174
  • Hadassah /ID# 154172
  • Rabin Medical Center /ID# 154176
  • Presidio Ospedaliero Vito Fazzi /ID# 170837
  • Fondazione PTV Policlinico Tor Vergata /ID# 152881
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 171220
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 152875
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 152883
  • Ospedale Policlinico San Martino /ID# 158104
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882
  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 152879
  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 152877
  • Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 152876
  • Aichi Cancer Center Hospital /ID# 200824
  • University of Fukui Hospital /ID# 167432
  • National Hospital Organization Kyushu Cancer Center /ID# 201111
  • Kyushu University Hospital /ID# 169095
  • Gunmaken Saiseikai Maebashi Hospital /ID# 168316
  • National Hospital Organization Mito Medical Center /ID# 168219
  • Hitachi General Hospital /ID# 201109
  • Duplicate_Kyoto Prefectural University of Medicine /ID# 167661
  • Tohoku University Hospital /ID# 169259
  • Nagasaki University Hospital /ID# 168632
  • Okayama University Hospital /ID# 204124
  • Duplicate_Kindai University Hospital /ID# 167662
  • Osaka Metropolitan University Hospital /ID# 169055
  • Saitama Medical University International Medical Center /ID# 167814
  • Juntendo University Hospital /ID# 168309
  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 168639
  • The Jikei University Daisan Hospital /ID# 168745
  • NTT Medical Center Tokyo /ID# 167975
  • Yamagata University Hospital /ID# 167634
  • Duplicate_Konkuk University Medical Ctr /ID# 153973
  • Seoul National University Hospital /ID# 153675
  • Samsung Medical Center /ID# 153674
  • Akershus universitetssykehus /ID# 154279
  • Drammen Sykehus /ID# 154280
  • Haukeland University Hospital /ID# 154281
  • Sykehuset Ostfold Kalnes /ID# 157755
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153389
  • Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym im. Ludwika Rydygiera w /ID# 169846
  • SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 153385
  • Duplicate_Hospital de Braga /ID# 154797
  • IPO Porto FG, EPE /ID# 154138
  • VA Caribbean Healthcare System /ID# 160507
  • Kuzbass Regional Clinical Hospital /ID# 157461
  • Moscow State budget healthcare /ID# 155738
  • Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 153268
  • Duplicate_Regional Oncology Dispensary /ID# 153264
  • State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 157460
  • Saratov State Medical University n.a. V.I. Razumovskiy /ID# 153267
  • Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 155740
  • Samara State Medical University /ID# 157462
  • University of Pretoria /ID# 153682
  • Albert Alberts Stem Cell Transplant Centre /ID# 153684
  • Hospital Universitario de Navarra /ID# 153254
  • Hospital Clinic de Barcelona /ID# 153255
  • Hospital Santa Creu i Sant Pau /ID# 153193
  • Hospital Universitario de la Princesa /ID# 153256
  • Hospital General Universitario Gregorio Maranon /ID# 153260
  • Hospital Universitario 12 de Octubre /ID# 153258
  • Hospital Universitario Virgen de la Victoria /ID# 153257
  • Hospital Universitario y Politecnico La Fe /ID# 153259
  • Akademiska Sjukhuset /ID# 153034
  • Uddevalla sjukhus /ID# 156875
  • Dup_VO Hematologi /ID# 153174
  • Karolinska University Hospital /ID# 170003
  • Changhua Christian Hospital /ID# 153899
  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 153902
  • China Medical University Hospital /ID# 153904
  • National Taiwan University Hospital /ID# 153900
  • Hacettepe University Faculty of Medicine /ID# 202073
  • Ankara Universitesi Fakultesi /ID# 155200
  • Ondokuz Mayis Universitesi Tip /ID# 155201
  • Kyiv city clinical hospital #9 /ID# 153510
  • Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 153511
  • Kyiv Regional Onco Dispensary /ID# 153514
  • Poltava Reg Clin Hosp Sklifoso /ID# 153513

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

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

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2016
Last Updated
June 27, 2023
Sponsor
AbbVie
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02993523
Brief Title
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
Acronym
Viale-a
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
September 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia (AML)
Keywords
Acute Myeloid Leukemia, Venetoclax, Treatment Naïve, Azacitidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Solution for subcutaneous or intravenous administration.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
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)
Title
Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)
Description
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.
Time Frame
From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021)
Secondary Outcome Measure Information:
Title
Event-free Survival (EFS)
Description
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.
Time Frame
Measured up to 2 years after the last participant is randomized
Title
Global Health Status/Quality of Life (GHS/QoL)
Description
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).
Time Frame
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
Title
Percentage of Participants Achieving Composite Complete Remission (CR or CRi)
Description
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.
Time Frame
Up to 6 months after the first 225 participants are randomized
Title
Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR+CRh)
Description
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.
Time Frame
Measured up to 2 years after the last participant is randomized
Title
Post Baseline Transfusion Independence Rate
Description
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.
Time Frame
Measured up to 2 years after the last participant is randomized
Title
Complete Remission (CR) Rate
Description
The percentage of participants with complete remission (CR) will be calculated based on the modified IWG criteria for AML.
Time Frame
Measured up to 2 years after the last participant is randomized
Title
Fatigue/Quality of Life (QoL)
Description
Fatigue QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue Short Form (SF) 7a global fatigue score
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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 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: 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. Exclusion Criteria: 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. 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope /ID# 154105
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California, Los Angeles /ID# 154107
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, Davis Comprehensive Cancer Center /ID# 162725
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Emory Midtown Infectious Disease Clinic /ID# 162534
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine /ID# 201133
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
University of Chicago Medicine /ID# 154108
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1426
Country
United States
Facility Name
Fort Wayne Medical Oncology /ID# 157190
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Cotton-O'Neil Clinical Res Ctr /ID# 155136
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Norton Cancer Institute /ID# 154992
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-3700
Country
United States
Facility Name
EMMC Cancer Care /ID# 154991
City
Brewer
State/Province
Maine
ZIP/Postal Code
04412
Country
United States
Facility Name
Johns Hopkins University /ID# 154104
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital /ID# 200752
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 201155
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Dana-Farber Cancer Institute /ID# 167009
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Sepctrum Health Medical Center /ID# 159522
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 154101
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077
City
New York
State/Province
New York
ZIP/Postal Code
10065-6007
Country
United States
Facility Name
Duke Cancer Center /ID# 154106
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-3000
Country
United States
Facility Name
University of Pittsburgh MC /ID# 154102
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
Tennessee Oncology-Nashville Centennial /ID# 200854
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center /ID# 154100
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Scott & White Medical Center- Temple /ID# 157191
City
Temple
State/Province
Texas
ZIP/Postal Code
76508-0001
Country
United States
Facility Name
University of Utah /ID# 157192
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Facility Name
University Of Vermont Medical /ID# 157196
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Princess Alexandra Hospital /ID# 154272
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital /ID# 154271
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Alfred Health /ID# 154275
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
St Vincent's Hospital Melbourne /ID# 155094
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
The Royal Melbourne Hospital /ID# 155095
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Sir Charles Gairdner Hospital /ID# 163924
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital /ID# 154274
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Universitaetsklinikum St. Poelten /ID# 167436
City
Sankt Poelten
State/Province
Niederoesterreich
ZIP/Postal Code
3100
Country
Austria
Facility Name
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 154888
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
Ordensklinikum Linz GmbH Elisabethinen /ID# 154885
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
Medizinische Universitaet Graz /ID# 157882
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Duplicate_Landeskrankenhaus Salzburg /ID# 169719
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Hanusch Krankenhaus /ID# 155676
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
UZ Brussel /ID# 153393
City
Jette
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UCL Saint-Luc /ID# 153391
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Gent /ID# 153392
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Sint-Jan Brugge /ID# 154041
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Hospital de Clinicas de Porto Alegre /ID# 157779
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 153099
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Instituto de Ensino e Pesquisa São Lucas /ID# 157778
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01236-030
Country
Brazil
Facility Name
Instituto do Câncer do Estado de São Paulo - ICESP /ID# 153095
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Tom Baker Cancer Centre /ID# 159645
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
St. Paul's Hospital /ID# 159644
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Juravinski Cancer Centre /ID# 153650
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Ottawa Hospital Research Institute /ID# 153541
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre /ID# 153651
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Fujian Medical University Union Hospital /ID# 167314
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Nanfang Hospital of Southern Medical University /ID# 170148
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The Second Hospital of Hebei Medical University /ID# 167316
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Henan Cancer Hospital /ID# 167320
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 167315
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 167493
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Jiangsu Province Hospital /ID# 167489
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The First Hospital of Jilin University /ID# 167490
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 167318
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
West China Hospital, Sichuan University /ID# 167492
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 167487
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 167317
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
Qilu Hospital of Shandong University /ID# 167485
City
Jinan
ZIP/Postal Code
250012
Country
China
Facility Name
Clinical Hospital Dubrava /ID# 153515
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicki bolnicki centar Zagreb /ID# 153383
City
Zagreb
State/Province
Grad Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Duplicate_Klinicki bolnicki centar Osijek /ID# 153623
City
Osijek
State/Province
Osjecko-baranjska Zupanija
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Fakultni Nemocnice Brno /ID# 154019
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Hradec Kralove /ID# 154021
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava /ID# 154017
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice Plzen /ID# 154018
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Aalborg University Hospital /ID# 154047
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Tampere University Hospital /ID# 154963
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
Facility Name
Helsinki University Hospital /ID# 155223
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00290
Country
Finland
Facility Name
Turku University Hospital /ID# 154964
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
CHU Bordeaux - Hopital Haut Leveque /ID# 153789
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
Chu Angers /Id# 153792
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
AP-HP - Hopital Saint-Louis /ID# 153787
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
IUCT Oncopole /ID# 153788
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Universitaetsklinikum Ulm /ID# 153054
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt /ID# 153060
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitaetsklinikum Muenster /ID# 153059
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitaetsklinikum Halle (Saale) /ID# 153058
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 153056
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover /ID# 153055
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 153812
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 153814
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 169854
City
Nyíregyháza
State/Province
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 153813
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 153816
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Duplicate_Semmelweis Egyetem /ID# 153815
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 158990
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
The Chaim Sheba Medical Center /ID# 154173
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 154175
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assaf Harofeh Medical Center /ID# 158063
City
Be'er Ya'aqov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 154174
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah /ID# 154172
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center /ID# 154176
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Presidio Ospedaliero Vito Fazzi /ID# 170837
City
Lecce
State/Province
Puglia
ZIP/Postal Code
73100
Country
Italy
Facility Name
Fondazione PTV Policlinico Tor Vergata /ID# 152881
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 171220
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 152875
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 152883
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Policlinico San Martino /ID# 158104
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 152882
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 152879
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 152877
City
Reggio Calabria
ZIP/Postal Code
89124
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 152876
City
Rome
ZIP/Postal Code
00189
Country
Italy
Facility Name
Aichi Cancer Center Hospital /ID# 200824
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
University of Fukui Hospital /ID# 167432
City
Yoshida-gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center /ID# 201111
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kyushu University Hospital /ID# 169095
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Gunmaken Saiseikai Maebashi Hospital /ID# 168316
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-0821
Country
Japan
Facility Name
National Hospital Organization Mito Medical Center /ID# 168219
City
Higashi
State/Province
Ibaraki
ZIP/Postal Code
311-3193
Country
Japan
Facility Name
Hitachi General Hospital /ID# 201109
City
Hitachi-shi
State/Province
Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
Duplicate_Kyoto Prefectural University of Medicine /ID# 167661
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Tohoku University Hospital /ID# 169259
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Nagasaki University Hospital /ID# 168632
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Okayama University Hospital /ID# 204124
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Duplicate_Kindai University Hospital /ID# 167662
City
Osaka-sayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka Metropolitan University Hospital /ID# 169055
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Saitama Medical University International Medical Center /ID# 167814
City
Hidaka-shi
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Juntendo University Hospital /ID# 168309
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 168639
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
The Jikei University Daisan Hospital /ID# 168745
City
Komae-shi
State/Province
Tokyo
ZIP/Postal Code
201-8601
Country
Japan
Facility Name
NTT Medical Center Tokyo /ID# 167975
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Yamagata University Hospital /ID# 167634
City
Yamagata-shi
State/Province
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Duplicate_Konkuk University Medical Ctr /ID# 153973
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 153675
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 153674
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Akershus universitetssykehus /ID# 154279
City
Nordlenangen
State/Province
Akershus
ZIP/Postal Code
1474
Country
Norway
Facility Name
Drammen Sykehus /ID# 154280
City
Drammen
State/Province
Buskerud
ZIP/Postal Code
3004
Country
Norway
Facility Name
Haukeland University Hospital /ID# 154281
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5021
Country
Norway
Facility Name
Sykehuset Ostfold Kalnes /ID# 157755
City
Gralum
ZIP/Postal Code
1714
Country
Norway
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 153389
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym im. Ludwika Rydygiera w /ID# 169846
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-826
Country
Poland
Facility Name
SP ZOZ Zespol Szpitali Miejskich w Chorzowie /ID# 153385
City
Chorzow
State/Province
Slaskie
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Duplicate_Hospital de Braga /ID# 154797
City
Braga
ZIP/Postal Code
4710-423
Country
Portugal
Facility Name
IPO Porto FG, EPE /ID# 154138
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
VA Caribbean Healthcare System /ID# 160507
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
Facility Name
Kuzbass Regional Clinical Hospital /ID# 157461
City
Kemerovo
State/Province
Kemerovskaya Oblast
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
Moscow State budget healthcare /ID# 155738
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Nizhny Novgorod Regional Clinical Hospital named N.A. Semashko /ID# 153268
City
Nizhniy Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Duplicate_Regional Oncology Dispensary /ID# 153264
City
Penza
State/Province
Penzenskaya Oblast
ZIP/Postal Code
440071
Country
Russian Federation
Facility Name
State Institution of Health of the Ryazan Regional Clinical Hospital /ID# 157460
City
Ryazan
State/Province
Ryazanskaya Oblast
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 153267
City
Saratov
State/Province
Saratovskaya Oblast
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Federal State Budgetary Ins NRC for Hematology of MoH of Russian Federation /ID# 155740
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Samara State Medical University /ID# 157462
City
Samara
ZIP/Postal Code
443099
Country
Russian Federation
Facility Name
University of Pretoria /ID# 153682
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Albert Alberts Stem Cell Transplant Centre /ID# 153684
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0044
Country
South Africa
Facility Name
Hospital Universitario de Navarra /ID# 153254
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 153255
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 153193
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario de la Princesa /ID# 153256
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 153260
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 153258
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria /ID# 153257
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 153259
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Akademiska Sjukhuset /ID# 153034
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Uddevalla sjukhus /ID# 156875
City
Uddevalla
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
451 80
Country
Sweden
Facility Name
Dup_VO Hematologi /ID# 153174
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Karolinska University Hospital /ID# 170003
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Changhua Christian Hospital /ID# 153899
City
Changhua city
State/Province
Changhua County
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 153902
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
China Medical University Hospital /ID# 153904
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 153900
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Hacettepe University Faculty of Medicine /ID# 202073
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara Universitesi Fakultesi /ID# 155200
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Facility Name
Ondokuz Mayis Universitesi Tip /ID# 155201
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Kyiv city clinical hospital #9 /ID# 153510
City
Kiev
State/Province
Vinnytska Oblast
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council /ID# 153511
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Kyiv Regional Onco Dispensary /ID# 153514
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Poltava Reg Clin Hosp Sklifoso /ID# 153513
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
35829925
Citation
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.
Results Reference
derived
PubMed Identifier
35696071
Citation
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.
Results Reference
derived
PubMed Identifier
35063965
Citation
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.
Results Reference
derived
PubMed Identifier
35046058
Citation
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.
Results Reference
derived
PubMed Identifier
34910556
Citation
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.
Results Reference
derived
PubMed Identifier
32786187
Citation
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.
Results Reference
derived
Links:
URL
http://rxabbvie.com
Description
Related Info

Learn more about this trial

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

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