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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04102020
Registration number
NCT04102020
Ethics application status
Date submitted
23/09/2019
Date registered
25/09/2019
Titles & IDs
Public title
A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
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Scientific title
Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
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Secondary ID [1]
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2023-507221-42-00
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Secondary ID [2]
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M19-708
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Universal Trial Number (UTN)
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Trial acronym
VIALE-M
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia (AML)
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Condition category
Condition code
Cancer
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0
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Leukaemia - Acute leukaemia
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Cancer
0
0
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0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
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0
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Venetoclax
Treatment: Drugs - Azacitidine
Treatment: Drugs - Azacitidine
Experimental: Part 1: Dose Confirmation - Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Experimental: Part 3 (Dose Finding): Dose Escalation - Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).
Experimental: Part 3 (Dose Finding): Safety Expansion - Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.
Treatment: Drugs: Venetoclax
Tablet: Oral
Treatment: Drugs: Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
Treatment: Drugs: Azacitidine
Oral Tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (AZA) (Part 1)
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Assessment method [1]
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DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.
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Timepoint [1]
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Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months
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Primary outcome [2]
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Number of Participants With DLTs of Venetoclax in Combination with Oral AZA (Part 3 Dose Finding Portion)
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Assessment method [2]
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DLTs are hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax in combination with oral AZA as described in the protocol and evaluated by the Investigator and the sponsor.
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Timepoint [2]
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Time from treatment of first participant to the 14th patient in Safety Expansion reaching the end of Cycle 1, approximately 16 months.
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Eligibility
Key inclusion criteria
* Diagnosis of newly diagnosed acute myeloid leukemia (AML).
* Participant meets the following disease activity criteria:
* Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
* Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies.
* AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
* Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of acute promyelocytic leukemia (APL).
* History of active central nervous system involvement with acute myeloid leukemia (AML).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/03/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/04/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
112
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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St George Hospital /ID# 215416 - Kogarah
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Liverpool Hospital /ID# 215415 - Liverpool
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Perth Blood Institute Ltd /ID# 217531 - Nedlands
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2217 - Kogarah
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2170 - Liverpool
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2541 - Nowra
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2500 - Wollongong
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4215 - SouthPort
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4350 - Toowoomba
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4102 - Woolloongabba
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5000 - Adelaide
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3128 - Box Hill
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3220 - Geelong
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6009 - Nedlands
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Commercial sector/industry
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Name
AbbVie
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Roche-Genentech
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Ethics approval
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Summary
Brief summary
This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.
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Trial website
https://clinicaltrials.gov/study/NCT04102020
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Trial related presentations / publications
Ivanov V, Yeh SP, Mayer J, Saini L, Unal A, Boyiadzis M, Hoffman DM, Kang K, Addo SN, Mendes WL, Fathi AT. Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia. Future Oncol. 2022 Aug;18(26):2879-2889. doi: 10.2217/fon-2022-0450. Epub 2022 Jul 19. Shallis RM, Podoltsev NA. Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission. Curr Opin Hematol. 2021 Mar 1;28(2):110-121. doi: 10.1097/MOH.0000000000000637.
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04102020