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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03844048




Registration number
NCT03844048
Ethics application status
Date submitted
15/02/2019
Date registered
18/02/2019

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
NA
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
27/02/2026
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
Isere
Country [14] 0 0
France
State/province [14] 0 0
Rhone
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
Taipei
Country [37] 0 0
Taiwan
State/province [37] 0 0
Taichung
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
Devon
Country [42] 0 0
United Kingdom
State/province [42] 0 0
England
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Hampshire
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Blackpool
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Liverpool
Country [46] 0 0
United Kingdom
State/province [46] 0 0
London
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
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?

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/NCT03844048