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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/NCT03844048




Registration number
NCT03844048
Ethics application status
Date submitted
15/02/2019
Date registered
18/02/2019
Date last updated
22/12/2023

Titles & IDs
Public title
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
Scientific title
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
Secondary ID [1] 0 0
2022-501522-38-00
Secondary ID [2] 0 0
M19-388
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Acute Myeloid Leukemia 0 0
Multiple Myeloma 0 0
Non-Hodgkin's Lymphoma 0 0
Acute Lymphoblastic Leukemia 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
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

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

Experimental: Venetoclax - Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled.


Treatment: Drugs: Venetoclax
oral; film-coated tablets or tablets for oral suspension
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
From first dose of study drug until 30 days following last dose of study drug (up to approximately 5 years).

Eligibility
Key inclusion criteria
- Subject has been enrolled and dosed in an ongoing venetoclax study and continues to
tolerate and derive benefit from the study drug.

- Male subject agrees to refrain from sperm donation.

- Female subjects must not be pregnant or breastfeeding.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- None.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
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
6/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/05/2025
Actual
Sample size
Target
Accrual to date
Final
165
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital /ID# 239557 - Camperdown
Recruitment hospital [2] 0 0
St George Hospital /ID# 225589 - Kogarah
Recruitment hospital [3] 0 0
Liverpool Hospital /ID# 225591 - Liverpool
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Ctr /ID# 210559 - Melbourne
Recruitment hospital [5] 0 0
Fiona Stanley Hospital /ID# 239480 - Murdoch
Recruitment hospital [6] 0 0
Perth Blood Institute Ltd /ID# 225592 - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New Hampshire
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Austria
State/province [8] 0 0
Steiermark
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles-Capitale
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
Denmark
State/province [11] 0 0
Hovedstaden
Country [12] 0 0
Denmark
State/province [12] 0 0
Midtjylland
Country [13] 0 0
France
State/province [13] 0 0
Rhone
Country [14] 0 0
France
State/province [14] 0 0
La Tronche
Country [15] 0 0
Greece
State/province [15] 0 0
Attiki
Country [16] 0 0
Greece
State/province [16] 0 0
Thessaloniki
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Hong Kong
Country [18] 0 0
Ireland
State/province [18] 0 0
Dublin
Country [19] 0 0
Japan
State/province [19] 0 0
Hyogo
Country [20] 0 0
Japan
State/province [20] 0 0
Ibaraki
Country [21] 0 0
Japan
State/province [21] 0 0
Okayama
Country [22] 0 0
Japan
State/province [22] 0 0
Tokyo
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Mexico
State/province [24] 0 0
Michoacan
Country [25] 0 0
Mexico
State/province [25] 0 0
Nuevo Leon
Country [26] 0 0
New Zealand
State/province [26] 0 0
Auckland
Country [27] 0 0
New Zealand
State/province [27] 0 0
Wellington
Country [28] 0 0
Poland
State/province [28] 0 0
Malopolskie
Country [29] 0 0
Poland
State/province [29] 0 0
Mazowieckie
Country [30] 0 0
Poland
State/province [30] 0 0
Slaskie
Country [31] 0 0
Portugal
State/province [31] 0 0
Lisboa
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Moskva
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Penzenskaya Oblast
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Sweden
State/province [35] 0 0
Skane Lan
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taichung
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taipei City
Country [38] 0 0
Turkey
State/province [38] 0 0
Ankara
Country [39] 0 0
Turkey
State/province [39] 0 0
Istanbul
Country [40] 0 0
Ukraine
State/province [40] 0 0
Dnipro
Country [41] 0 0
United Kingdom
State/province [41] 0 0
England
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Hampshire
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Blackpool
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Liverpool
Country [45] 0 0
United Kingdom
State/province [45] 0 0
London
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Plymouth
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this extension study is to provide venetoclax and obtain long-term safety data
for subjects who continue to tolerate and derive benefit from receiving venetoclax in ongoing
studies.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03844048
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/NCT03844048