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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01804686
Registration number
NCT01804686
Ethics application status
Date submitted
4/03/2013
Date registered
5/03/2013
Date last updated
14/08/2024
Titles & IDs
Public title
A Long-term Extension Study of PCI-32765 (Ibrutinib)
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Scientific title
A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
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Secondary ID [1]
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0
2012-004225-24
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Secondary ID [2]
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0
CR100955
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Universal Trial Number (UTN)
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Trial acronym
CAN3001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia
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0
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Small Lymphocytic Lymphoma
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0
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Mantle Cell Lymphoma
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0
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Follicular Lymphoma
0
0
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Diffuse Large B-cell Lymphoma
0
0
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Waldenstrom Macroglobulinemia
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0
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Chronic Graft Versus Host Disease
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
0
0
0
0
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Children's - Leukaemia & Lymphoma
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Cancer
0
0
0
0
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Leukaemia - Acute leukaemia
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Cancer
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0
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Leukaemia - Chronic leukaemia
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Respiratory
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0
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Other respiratory disorders / diseases
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ibrutinib
Experimental: Ibrutinib -
Treatment: Drugs: Ibrutinib
Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants affected by an adverse event
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Assessment method [1]
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Timepoint [1]
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Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier
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Secondary outcome [1]
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Number of participants with change in disease status
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Assessment method [1]
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Timepoint [1]
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Up to the end-of-treatment visit (up to 30 days after the last dose of study medication), or until the start of a subsequent anti-caner therapy, if earlier
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Eligibility
Key inclusion criteria
* Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib
* Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks
* Agrees to protocol-defined use of effective contraception
* Negative blood or urine pregnancy test at screening
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Requires anticoagulation with warfarin or equivalent vitamin K antagonists
* Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
* Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/09/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/01/2027
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Actual
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Sample size
Target
700
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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John Fawkner Cancer Trial Centre - Coburg
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Concord Hospital - Concord
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Austin Health - Heidelberg
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Peter MacCallum Cancer Institute - Melbourne
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Royal Perth Hospital - Perth
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Recruitment hospital [7]
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Alfred Hospital - Prahran
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Recruitment hospital [8]
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Adventist Health Care Limited trading as San Clinical Trials Unit - Wahroonga
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3058 - Coburg
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Recruitment postcode(s) [3]
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2139 - Concord
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3084 - Heidelberg
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3000 - Melbourne
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Recruitment postcode(s) [6]
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6847 - Perth
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Recruitment postcode(s) [7]
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3181 - Prahran
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Recruitment postcode(s) [8]
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2076 - Wahroonga
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Recruitment outside Australia
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California
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Cherkasy
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Ukraine
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Dnepropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Khmelnitskiy
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Ukraine
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Kiev
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Ukraine
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Lviv
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Ukraine
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Vinnitsa
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United Kingdom
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Birmingham
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United Kingdom
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Bournemouth
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United Kingdom
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Colchester
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United Kingdom
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Glasgow
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Country [141]
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United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Nottingham
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Country [146]
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United Kingdom
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Plymouth
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United Kingdom
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Sheffield
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Country [148]
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United Kingdom
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State/province [148]
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Southampton
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Country [149]
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United Kingdom
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State/province [149]
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Pharmacyclics LLC.
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Address [1]
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Ethics approval
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Summary
Brief summary
The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.
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Trial website
https://clinicaltrials.gov/study/NCT01804686
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT01804686
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