COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02993523




Registration number
NCT02993523
Ethics application status
Date submitted
13/12/2016
Date registered
15/12/2016
Date last updated
28/02/2020

Titles & IDs
Public title
A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
Scientific 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
Secondary ID [1] 0 0
2016-001466-28
Secondary ID [2] 0 0
M15-656
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia (AML) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Azacitidine
Treatment: Drugs - Venetoclax
Treatment: Drugs - Placebo

Placebo Comparator: Placebo followed by Azacitidine - Matching Placebo for Venetoclax 400 mg orally QD on Days 1 - 28 plus Azacitidine 75 mg/m^2 SC or IV QD on Days 1 - 7 (28-day cycle)

Active Comparator: Venetoclax followed by Azacitidine - Venetoclax 400 mg orally every day (QD) on Days 1 - 28 plus Azacitidine 75 mg/m^2 subcutaneously (SC) or intravenous (IV) QD on Cycle Days 1 - 7 (28-day cycle)


Treatment: Drugs: Azacitidine
Solution for subcutaneous or intravenous administration

Treatment: Drugs: Venetoclax
Tablet

Treatment: Drugs: Placebo
Tablet

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall survival (OS) - OS is defined as the number of days from the date of randomization to the date of death.
Timepoint [1] 0 0
Measured up to 2 years after the last participant is randomized
Primary outcome [2] 0 0
Percentage of participants with complete remission (CR) and complete remission with incomplete marrow recovery (CRi) - This will be 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.
Timepoint [2] 0 0
Measured up to 2 years after the last participant is randomized
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Measured up to 2 years after the last participant is randomized
Secondary outcome [2] 0 0
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).
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Up to 6 months after the first 225 participants are randomized
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Measured up to 2 years after the last participant is randomized
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Measured up to 2 years after the last participant is randomized
Secondary outcome [6] 0 0
Complete remission (CR) rate - The percentage of participants with complete remission (CR) will be calculated based on the modified IWG criteria for AML.
Timepoint [6] 0 0
Measured up to 2 years after the last participant is randomized
Secondary outcome [7] 0 0
Fatigue/quality of life (QoL) - Fatigue QoL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) and Cancer Fatigue Short Form (SF) 7a global fatigue score
Timepoint [7] 0 0
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

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital /ID# 154272 - Woolloongabba
Recruitment hospital [2] 0 0
Royal Adelaide Hospital /ID# 154271 - Adelaide
Recruitment hospital [3] 0 0
St. Vincents Hosp Melbourne /ID# 155094 - Fitzroy
Recruitment hospital [4] 0 0
Royal Melbourne Hospital /ID# 155095 - Parkville
Recruitment hospital [5] 0 0
The Alfred Hospital /ID# 154275 - Prahran
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital /ID# 163924 - Nedlands
Recruitment hospital [7] 0 0
Royal Perth Hospital /ID# 154274 - Shenton Park
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
3181 - Prahran
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
6008 - Shenton Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Vermont
Country [18] 0 0
Austria
State/province [18] 0 0
Niederoesterreich
Country [19] 0 0
Austria
State/province [19] 0 0
Oberoesterreich
Country [20] 0 0
Austria
State/province [20] 0 0
Graz
Country [21] 0 0
Austria
State/province [21] 0 0
Linz
Country [22] 0 0
Austria
State/province [22] 0 0
Salzburg
Country [23] 0 0
Austria
State/province [23] 0 0
Wien
Country [24] 0 0
Belgium
State/province [24] 0 0
Bruxelles-Capitale
Country [25] 0 0
Belgium
State/province [25] 0 0
Oost-Vlaanderen
Country [26] 0 0
Belgium
State/province [26] 0 0
West-Vlaanderen
Country [27] 0 0
Belgium
State/province [27] 0 0
Jette, Brussels
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio Grande Do Sul
Country [29] 0 0
Brazil
State/province [29] 0 0
Sao Paulo
Country [30] 0 0
Canada
State/province [30] 0 0
Alberta
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
China
State/province [33] 0 0
Fujian
Country [34] 0 0
China
State/province [34] 0 0
Guangdong
Country [35] 0 0
China
State/province [35] 0 0
Hubei
Country [36] 0 0
China
State/province [36] 0 0
Jiangsu
Country [37] 0 0
China
State/province [37] 0 0
Jilin
Country [38] 0 0
China
State/province [38] 0 0
Shanghai
Country [39] 0 0
China
State/province [39] 0 0
Sichuan
Country [40] 0 0
China
State/province [40] 0 0
Tianjin
Country [41] 0 0
China
State/province [41] 0 0
Zhejiang
Country [42] 0 0
China
State/province [42] 0 0
Jinan
Country [43] 0 0
China
State/province [43] 0 0
Shijiazhuang
Country [44] 0 0
China
State/province [44] 0 0
Wuhan
Country [45] 0 0
China
State/province [45] 0 0
Zhengzhou Henan
Country [46] 0 0
Croatia
State/province [46] 0 0
Grad Zagreb
Country [47] 0 0
Croatia
State/province [47] 0 0
Osjecko-baranjska Zupanija
Country [48] 0 0
Czechia
State/province [48] 0 0
Plzen-jih
Country [49] 0 0
Czechia
State/province [49] 0 0
Brno
Country [50] 0 0
Czechia
State/province [50] 0 0
Hradec Kralove
Country [51] 0 0
Czechia
State/province [51] 0 0
Ostrava
Country [52] 0 0
Denmark
State/province [52] 0 0
Nordjylland
Country [53] 0 0
Finland
State/province [53] 0 0
Pirkanmaa
Country [54] 0 0
Finland
State/province [54] 0 0
Uusimaa
Country [55] 0 0
Finland
State/province [55] 0 0
Turku
Country [56] 0 0
France
State/province [56] 0 0
Angers
Country [57] 0 0
France
State/province [57] 0 0
Paris
Country [58] 0 0
France
State/province [58] 0 0
Pessac Cedex
Country [59] 0 0
France
State/province [59] 0 0
Toulouse
Country [60] 0 0
Germany
State/province [60] 0 0
Thueringen
Country [61] 0 0
Germany
State/province [61] 0 0
Frankfurt
Country [62] 0 0
Germany
State/province [62] 0 0
Halle
Country [63] 0 0
Germany
State/province [63] 0 0
Hamburg
Country [64] 0 0
Germany
State/province [64] 0 0
Hannover
Country [65] 0 0
Germany
State/province [65] 0 0
Muenster
Country [66] 0 0
Hungary
State/province [66] 0 0
Budapest
Country [67] 0 0
Hungary
State/province [67] 0 0
Debrecen
Country [68] 0 0
Hungary
State/province [68] 0 0
Kaposvar
Country [69] 0 0
Hungary
State/province [69] 0 0
Nyíregyhaza
Country [70] 0 0
Hungary
State/province [70] 0 0
Szeged
Country [71] 0 0
Israel
State/province [71] 0 0
Tel-Aviv
Country [72] 0 0
Israel
State/province [72] 0 0
Be'er Ya'akov
Country [73] 0 0
Israel
State/province [73] 0 0
Haifa
Country [74] 0 0
Israel
State/province [74] 0 0
Jerusalem
Country [75] 0 0
Israel
State/province [75] 0 0
Ramat Gan
Country [76] 0 0
Israel
State/province [76] 0 0
Tel-aviv
Country [77] 0 0
Italy
State/province [77] 0 0
Emilia-Romagna
Country [78] 0 0
Italy
State/province [78] 0 0
Lombardia
Country [79] 0 0
Italy
State/province [79] 0 0
Marche
Country [80] 0 0
Italy
State/province [80] 0 0
Puglia
Country [81] 0 0
Italy
State/province [81] 0 0
Roma
Country [82] 0 0
Italy
State/province [82] 0 0
Bergamo
Country [83] 0 0
Italy
State/province [83] 0 0
Genoa
Country [84] 0 0
Italy
State/province [84] 0 0
Napoli
Country [85] 0 0
Italy
State/province [85] 0 0
Reggio Calabria
Country [86] 0 0
Italy
State/province [86] 0 0
Rome
Country [87] 0 0
Japan
State/province [87] 0 0
Aichi
Country [88] 0 0
Japan
State/province [88] 0 0
Fukui
Country [89] 0 0
Japan
State/province [89] 0 0
Fukuoka
Country [90] 0 0
Japan
State/province [90] 0 0
Gunma
Country [91] 0 0
Japan
State/province [91] 0 0
Ibaraki
Country [92] 0 0
Japan
State/province [92] 0 0
Kyoto
Country [93] 0 0
Japan
State/province [93] 0 0
Miyagi
Country [94] 0 0
Japan
State/province [94] 0 0
Nagasaki
Country [95] 0 0
Japan
State/province [95] 0 0
Okayama
Country [96] 0 0
Japan
State/province [96] 0 0
Osaka
Country [97] 0 0
Japan
State/province [97] 0 0
Saitama
Country [98] 0 0
Japan
State/province [98] 0 0
Tokyo
Country [99] 0 0
Japan
State/province [99] 0 0
Yamagata
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Seoul Teugbyeolsi
Country [101] 0 0
Korea, Republic of
State/province [101] 0 0
Seoul
Country [102] 0 0
Norway
State/province [102] 0 0
Akershus
Country [103] 0 0
Norway
State/province [103] 0 0
Buskerud
Country [104] 0 0
Norway
State/province [104] 0 0
Hordaland
Country [105] 0 0
Norway
State/province [105] 0 0
Gralum
Country [106] 0 0
Poland
State/province [106] 0 0
Dolnoslaskie
Country [107] 0 0
Poland
State/province [107] 0 0
Malopolskie
Country [108] 0 0
Poland
State/province [108] 0 0
Chorzow
Country [109] 0 0
Portugal
State/province [109] 0 0
Braga
Country [110] 0 0
Portugal
State/province [110] 0 0
Porto
Country [111] 0 0
Puerto Rico
State/province [111] 0 0
San Juan
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Kemerovskaya Oblast
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Nizhegorodskaya Oblast
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Penzenskaya Oblast
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Ryazanskaya Oblast
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Saratovskaya Oblast
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Moscow
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Samara
Country [119] 0 0
South Africa
State/province [119] 0 0
Gauteng
Country [120] 0 0
Spain
State/province [120] 0 0
Barcelona
Country [121] 0 0
Spain
State/province [121] 0 0
Madrid
Country [122] 0 0
Spain
State/province [122] 0 0
Malaga
Country [123] 0 0
Spain
State/province [123] 0 0
Pamplona
Country [124] 0 0
Spain
State/province [124] 0 0
Valencia
Country [125] 0 0
Sweden
State/province [125] 0 0
Uppsala Lan
Country [126] 0 0
Sweden
State/province [126] 0 0
Vastra Gotalands Lan
Country [127] 0 0
Sweden
State/province [127] 0 0
Lund
Country [128] 0 0
Sweden
State/province [128] 0 0
Stockholm
Country [129] 0 0
Taiwan
State/province [129] 0 0
Taichung
Country [130] 0 0
Taiwan
State/province [130] 0 0
Taipei
Country [131] 0 0
Taiwan
State/province [131] 0 0
Changhua County
Country [132] 0 0
Taiwan
State/province [132] 0 0
Kaohsiung
Country [133] 0 0
Turkey
State/province [133] 0 0
Ankara
Country [134] 0 0
Turkey
State/province [134] 0 0
Samsun
Country [135] 0 0
Ukraine
State/province [135] 0 0
Vinnytska Oblast
Country [136] 0 0
Ukraine
State/province [136] 0 0
Dnipro
Country [137] 0 0
Ukraine
State/province [137] 0 0
Kyiv
Country [138] 0 0
Ukraine
State/province [138] 0 0
Poltava

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02993523
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications