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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/NCT03229200




Registration number
NCT03229200
Ethics application status
Date submitted
5/06/2017
Date registered
25/07/2017
Date last updated
24/11/2023

Titles & IDs
Public title
Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
Scientific title
Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.
Secondary ID [1] 0 0
2016-004356-30
Secondary ID [2] 0 0
PCYC-1145-LT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, B-Cell 0 0
Lymphoma, Non-Hodgkin 0 0
Leukemia, B-cell 0 0
Graft Vs Host Disease 0 0
Solid Tumor 0 0
Condition category
Condition code
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
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ibrutinib

Experimental: Ibrutinib - Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.


Treatment: Drugs: Ibrutinib
Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria.
Timepoint [1] 0 0
The duration will be 3 years and will be re-evaluated.
Secondary outcome [1] 0 0
Characterize the drug safety profile by collecting long-term safety data for ibrutinib.
Timepoint [1] 0 0
Up to 3 years and will be re-evaluated.

Eligibility
Key inclusion criteria
- Subject must have participated in an eligible ibrutinib clinical trial, may derive
clinical benefit from continued treatment or restart of treatment with ibrutinib in
the opinion of the treating physician and does not have access to commercial ibrutinib
within their region and/or the drug is not reasonably accessible to the patient within
the respective region.

- Ongoing continuous treatment with ibrutinib.

- Subject must have completed all assessments in their parent protocol and want to
continue treatment with ibrutinib.

- Subject or their legally authorized representative must voluntarily sign and date an
informed consent approved by an independent ethics committee (IEC)/institutional
review board (IRB) to the long term treatment extension protocol and not withdrawn
consent from the parent study.

- Male and female subjects of reproductive potential who agree to use both a highly
effective method of birth control and a barrier method during the period of therapy
and for 90 days after the last dose of drug.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Meeting any requirement in the parent protocol to permanently discontinue ibrutinib
treatment.

- Any condition or situation which, in the opinion of the treating physician, may
interfere significantly with a subject's participation in the protocol.

- Female subjects who are pregnant, or breastfeeding, or planning to become pregnant
while enrolled in this protocol or within 90 days of last dose of drug treatment. Male
subjects who plan to father a child while enrolled in this protocol or within 90 days
after the last dose of drug treatment.

- Unwilling or unable to participate in all required evaluations and procedures.

- Unable to understand the purpose and risks of the protocol and to provide a signed and
dated informed consent form (ICF) and authorization to use protected health
information.

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 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/07/2027
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St. George Hospital - Kogarah
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Haematology Clinical Trials - Sydney
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
Ballarat Health Services - Ballarat
Recruitment hospital [6] 0 0
Eastern Health - Box Hill
Recruitment hospital [7] 0 0
Monash Health-Monash Medical Centre - Clayton
Recruitment hospital [8] 0 0
St Vincent Hospital - Fitzroy
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2139 - Sydney
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5067 - Bedford Park
Recruitment postcode(s) [5] 0 0
3350 - Ballarat
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3168 - Clayton
Recruitment postcode(s) [8] 0 0
3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
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
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New Mexico
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Vermont
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Canada
State/province [18] 0 0
Nova Scotia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Czechia
State/province [21] 0 0
Kralovehradecky Kraj
Country [22] 0 0
Czechia
State/province [22] 0 0
Brno
Country [23] 0 0
Czechia
State/province [23] 0 0
Pilsen
Country [24] 0 0
Czechia
State/province [24] 0 0
Prague
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha 10
Country [26] 0 0
France
State/province [26] 0 0
Loire Atlantique
Country [27] 0 0
France
State/province [27] 0 0
Rouen Cedex
Country [28] 0 0
France
State/province [28] 0 0
Saint-Brieuc
Country [29] 0 0
Hungary
State/province [29] 0 0
Budapest
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Padova
Country [32] 0 0
Italy
State/province [32] 0 0
Pavia
Country [33] 0 0
Italy
State/province [33] 0 0
Torino
Country [34] 0 0
Italy
State/province [34] 0 0
Udine
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Daegu
Country [36] 0 0
New Zealand
State/province [36] 0 0
Auckland
Country [37] 0 0
Poland
State/province [37] 0 0
Podkarpackie
Country [38] 0 0
Poland
State/province [38] 0 0
Pomorskie
Country [39] 0 0
Poland
State/province [39] 0 0
Silesia
Country [40] 0 0
Poland
State/province [40] 0 0
Lódz
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Nizhegorodskaya
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Ryazan Region
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Saint Petersburg
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Yaroslavl
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona
Country [46] 0 0
Spain
State/province [46] 0 0
Madrid
Country [47] 0 0
Spain
State/province [47] 0 0
Salamanca
Country [48] 0 0
Sweden
State/province [48] 0 0
Norrbotten
Country [49] 0 0
Sweden
State/province [49] 0 0
Borås
Country [50] 0 0
Sweden
State/province [50] 0 0
Solna
Country [51] 0 0
Taiwan
State/province [51] 0 0
Taichung
Country [52] 0 0
Taiwan
State/province [52] 0 0
Taipei
Country [53] 0 0
Turkey
State/province [53] 0 0
Pamukkale
Country [54] 0 0
Turkey
State/province [54] 0 0
Ankara
Country [55] 0 0
Turkey
State/province [55] 0 0
Istanbul
Country [56] 0 0
Turkey
State/province [56] 0 0
Izmir
Country [57] 0 0
Ukraine
State/province [57] 0 0
Cherkasy
Country [58] 0 0
Ukraine
State/province [58] 0 0
Dnipro
Country [59] 0 0
Ukraine
State/province [59] 0 0
Lviv
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Cardiff
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Leeds
Country [62] 0 0
United Kingdom
State/province [62] 0 0
London
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pharmacyclics Switzerland GmbH
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Janssen Biotech, Inc., including Johnson & Johnson
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Multicenter, open-label, prospective treatment protocol that provides continued access to
ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from
treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying
disease within their region.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03229200
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kevin Wu
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/NCT03229200