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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04161885




Registration number
NCT04161885
Ethics application status
Date submitted
11/11/2019
Date registered
13/11/2019

Titles & IDs
Public title
A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)
Scientific title
A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine After Allogeneic Stem Cell Transplantation in Subjects With Acute Myeloid Leukemia (AML) (VIALE-T)
Secondary ID [1] 0 0
2023-507222-17-00
Secondary ID [2] 0 0
M19-063
Universal Trial Number (UTN)
Trial acronym
VIALE-T
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia (AML) 0 0
Cancer 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
Other interventions - Best Supportive Care (BSC)

Experimental: Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care - Participants will be administered various doses and dose regiments of venetoclax and AZA. Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days)

Experimental: Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC - Participants will be administered with venetoclax and AZA at a dose level determined in Part 1 in addition to best supportive care (when required). Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days).

Experimental: Part 2: Arm B - Best Supportive Care (BSC) - Participants will receive treatment as prescribed by their physician according to the BSC for up to 24 cycles (1 cycle = 28 days)


Treatment: Drugs: Venetoclax
Tablet; Oral

Treatment: Drugs: Azacitidine
Subcutaneous (SC) or intravenous (IV) injection

Other interventions: Best Supportive Care (BSC)
BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1)
Timepoint [1] 0 0
Up to the first treatment cycle (28 days)
Primary outcome [2] 0 0
Overall Survival (OS) (Part 2)
Timepoint [2] 0 0
Up to 45 months after the first participant is randomized
Secondary outcome [1] 0 0
Morphologic Relapse-Free Survival (RFS) (Part 2)
Timepoint [1] 0 0
Up to 39 months after the first participant is randomized
Secondary outcome [2] 0 0
Composite Relapse-Free Survival (RFS) (Part 2)
Timepoint [2] 0 0
Up to 39 months after the first participant is randomized
Secondary outcome [3] 0 0
Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2)
Timepoint [3] 0 0
Up to 39 months after the first participant is randomized
Secondary outcome [4] 0 0
Graft-versus-Host Disease (GvHD) Rate (Part 2)
Timepoint [4] 0 0
Up to 39 months after the first participant is randomized
Secondary outcome [5] 0 0
Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) (Part 2)
Timepoint [5] 0 0
Up to 39 months after the first participant is randomized
Secondary outcome [6] 0 0
Change From Randomization in Fatigue in Adult Participants (Part 2)
Timepoint [6] 0 0
Up to 39 months after the first participant is randomized
Secondary outcome [7] 0 0
Measurable Residual Disease (MRD) Response Rate in Participants With MRD >= 10^-3 at Randomization (Part 2)
Timepoint [7] 0 0
Up to 39 months after the first participant is randomized
Secondary outcome [8] 0 0
Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2)
Timepoint [8] 0 0
Up to 39 months after the first participant is randomized
Secondary outcome [9] 0 0
Change in Patient Reported Signs, Symptoms and Impact of Acute Myeloid Leukemia (AML) as Measured by the European Quality-of-Life-5 Dimensional-5-Level (EQ-5D-5L)
Timepoint [9] 0 0
Up to 39 months after the first participant is randomized

Eligibility
Key inclusion criteria
* Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2.
* Participant must be diagnosed with Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 60 days.
* Blast percentage in bone marrow before transplant must be < 10%.
* Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must be < 5% after transplant.
* Participant meet adequate renal, hepatic and hematologic criteria as described in the protocol.
* Participants >= 17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and participants between 12 to 16 years old must have a Lansky Play Performance Scale score > 40.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of disease progression during prior treatment with venetoclax.
* History of any other malignancy within 2 years prior to study entry, except for: 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; Myelodysplastic Syndrome, Myeloproliferative neoplasm (only allowed if it transformed to AML and AML should be the indication for marrow transplantation).
* Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
* Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.

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
Open (masking not used)
Who is / are masked / blinded?



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
26/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
Accrual to date
Final
465
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
The Kinghorn Cancer Centre /ID# 214660 - Darlinghurst
Recruitment hospital [2] 0 0
Royal Adelaide Hospital /ID# 215678 - Adelaide
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Ctr /ID# 214653 - Melbourne
Recruitment hospital [4] 0 0
The Alfred Hospital /ID# 240931 - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
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Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

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 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)
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?
To learn more about 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?

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/NCT04161885