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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04102020




Registration number
NCT04102020
Ethics application status
Date submitted
23/09/2019
Date registered
25/09/2019
Date last updated
25/10/2023

Titles & IDs
Public title
A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Scientific title
A Multicenter, Phase 3 Study of Venetoclax and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M)
Secondary ID [1] 0 0
2019-002217-19
Secondary ID [2] 0 0
M19-708
Universal Trial Number (UTN)
Trial acronym
VIALE-M
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 - Venetoclax
Treatment: Drugs - Azacitidine
Treatment: Drugs - CC-486

Experimental: Part 1: Dose Confirmation - Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 48 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, CC-486 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, CC-486 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: CC-486
Tablet; Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Dose-Limiting Toxicities (DLTs) (Part 1)
Timepoint [1] 0 0
Time from treatment of first participant to 20th participant reaching end of cycle 1, approximately 7 Months
Primary outcome [2] 0 0
Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination with Azacitidine (CC-486) (Part 3 Dose Finding Portion)
Timepoint [2] 0 0
Time from treatment of first participant to the 14th patient in Safety Expansion reaching the end of Cycle 1, approximately 16 months.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of acute promyelocytic leukemia (APL).

- History of active central nervous system involvement with acute myeloid leukemia
(AML).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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
26/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital /ID# 215416 - Kogarah
Recruitment hospital [2] 0 0
Liverpool Hospital /ID# 215415 - Liverpool
Recruitment hospital [3] 0 0
Shoalhaven District Memorial Hospital /ID# 221973 - Nowra
Recruitment hospital [4] 0 0
Wollongong Hospital /ID# 216071 - Wollongong
Recruitment hospital [5] 0 0
Gold coast University Hospital /ID# 214650 - SouthPort
Recruitment hospital [6] 0 0
Toowoomba Hospital /ID# 217922 - Toowoomba
Recruitment hospital [7] 0 0
Princess Alexandra Hospital /ID# 238753 - Woolloongabba
Recruitment hospital [8] 0 0
Royal Adelaide Hospital /ID# 238754 - Adelaide
Recruitment hospital [9] 0 0
Box Hill Hospital /ID# 217622 - Box Hill
Recruitment hospital [10] 0 0
Barwon Health /ID# 217921 - Geelong
Recruitment hospital [11] 0 0
Perth Blood Institute Ltd /ID# 217531 - Nedlands
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2541 - Nowra
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4215 - SouthPort
Recruitment postcode(s) [6] 0 0
4350 - Toowoomba
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3220 - Geelong
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment outside Australia
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Alabama
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Ostrava
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Praha
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Gironde
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Vas
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Rio Piedras
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Nizhegorodskaya Oblast
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Russian Federation
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Malaga
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Kaohsiung
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Taichung
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Istanbul
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Trabzon
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Bristol, City Of
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England
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London, City Of
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Wales
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Birmingham
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United Kingdom
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London

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
Roche-Genentech
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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 AZA. Part 3 will
be the Dose Finding portion to determine RPTD of venetoclax in combination with CC-486. Part
2 and Part 3 Randomization of the study were removed.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04102020
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04102020