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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02993523
Ethics application status
Date submitted
13/12/2016
Date registered
15/12/2016

Titles & IDs
Public 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
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
Viale-a
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: 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).

Active comparator: 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).

Active comparator: 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).


Treatment: Drugs: Azacitidine
Solution for subcutaneous or intravenous administration.

Treatment: Drugs: Venetoclax
Tablet

Treatment: Drugs: Placebo
Matching placebo tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
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)
Primary outcome [2] 0 0
Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)
Timepoint [2] 0 0
From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021)
Secondary outcome [1] 0 0
Event-free Survival (EFS)
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)
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)
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)
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
Timepoint [5] 0 0
Measured up to 2 years after the last participant is randomized
Secondary outcome [6] 0 0
Complete Remission (CR) Rate
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)
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. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
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 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.)

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
2/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/01/2026
Actual
Sample size
Target
Accrual to date
Final
443
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
Alfred Health /ID# 154275 - Melbourne
Recruitment hospital [4] 0 0
St Vincent's Hospital Melbourne /ID# 155094 - Melbourne
Recruitment hospital [5] 0 0
The Royal Melbourne Hospital /ID# 155095 - Parkville
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital /ID# 163924 - Nedlands
Recruitment hospital [7] 0 0
Royal Perth Hospital /ID# 154274 - Perth
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3065 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment outside Australia
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California
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Halle (Saale)
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Hannover
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Russian Federation
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Kemerovskaya Oblast
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Russian Federation
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Moskva
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Russian Federation
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Nizhegorodskaya Oblast
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Russian Federation
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Penzenskaya Oblast
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Russian Federation
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Saratovskaya Oblast
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Moscow
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Samara
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South Africa
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Gauteng
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Spain
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Navarra
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Valencia
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Sweden
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Uppsala Lan
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Sweden
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Vastra Gotalands Lan
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Sweden
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Lund
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Sweden
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Stockholm
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Taiwan
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Changhua County
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Taiwan
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Kaohsiung
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Taiwan
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Taichung City
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Taiwan
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Taipei City
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Turkey
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Ankara
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Turkey
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Samsun
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Ukraine
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Vinnytska Oblast
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Ukraine
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Dnipro
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Ukraine
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Kyiv
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Ukraine
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
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/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02993523