Trial Review

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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/NCT01804686




Registration number
NCT01804686
Ethics application status
Date submitted
4/03/2013
Date registered
5/03/2013
Date last updated
23/05/2024

Titles & IDs
Public title
A Long-term Extension Study of PCI-32765 (Ibrutinib)
Scientific title
A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
Secondary ID [1] 0 0
2012-004225-24
Secondary ID [2] 0 0
CR100955
Universal Trial Number (UTN)
Trial acronym
CAN3001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Small Lymphocytic Lymphoma 0 0
Mantle Cell Lymphoma 0 0
Follicular Lymphoma 0 0
Diffuse Large B-cell Lymphoma 0 0
Waldenstrom Macroglobulinemia 0 0
Chronic Graft Versus Host Disease 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
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Respiratory 0 0 0 0
Other respiratory disorders / diseases
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: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants affected by an adverse event
Timepoint [1] 0 0
Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier
Secondary outcome [1] 0 0
Number of participants with change in disease status
Timepoint [1] 0 0
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

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/01/2027
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
John Fawkner Cancer Trial Centre - Coburg
Recruitment hospital [3] 0 0
Concord Hospital - Concord
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Institute - Melbourne
Recruitment hospital [6] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [7] 0 0
Alfred Hospital - Prahran
Recruitment hospital [8] 0 0
Adventist Health Care Limited trading as San Clinical Trials Unit - Wahroonga
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3058 - Coburg
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
6847 - Perth
Recruitment postcode(s) [7] 0 0
3181 - Prahran
Recruitment postcode(s) [8] 0 0
2076 - Wahroonga
Recruitment outside Australia
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United States of America
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California
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Connecticut
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Illinois
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Indiana
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Kentucky
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Massachusetts
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Michigan
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Dakota
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Texas
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Virginia
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Washington
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West Virginia
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Wisconsin
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Argentina
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Ciudad Autonoma Buenos Aires
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Ciudad de Buenos Aires
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Belgium
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Antwerp
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Brugge
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Brussels
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Gent
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Leuven
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Yvoir
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Rio De Janeiro
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Canada
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Quebec
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Chengdu
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Fuzhou
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Shanghai
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China
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Shanxi
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China
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Tianjin
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Wuhan
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Bogota
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Colombia
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Brno
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Pessac
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Pierre Benite
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France
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Tours
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Berlin
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Dresden
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Essen
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Gießen
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Heidelberg
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Homburg/Saar
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Magdeburg
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Marburg
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Ulm
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Athens
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Greece
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Thessalonikis
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Hungary
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Budapest N/a
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Hungary
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Szeged
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Ireland
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Dublin
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Hadera
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Haifa
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Israel
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Petah Tikva
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Israel
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Ramat-Gan
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Israel
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Tel Aviv
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Italy
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Milano
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Italy
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Roma
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Torino
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Bunkyo-ku
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Hiroshima shi
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Sapporo-shi
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Korea, Republic of
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Goyang-Si
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Korea, Republic of
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Seoul
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Mexico
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Oaxaca
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Netherlands
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Amsterdam
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Brzozow
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Chorzów
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Gdansk
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Krakow
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Opole
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Slupsk
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Wroclaw
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Portugal
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Lisboa
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Portugal
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Lisbon
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Portugal
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Porto
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Puerto Rico
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San Juan
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Russian Federation
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Arkhangelsk
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Russian Federation
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Chelyabinsk
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Russian Federation
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Dzerzhinsk
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Russian Federation
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Moscow N/a
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Russian Federation
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Moscow
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Russian Federation
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Nizhni Novgorod
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Obninsk
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Perm
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Petrozavodsk
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Rostov-Na-Donu
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Ryazan
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Samara
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Sochi
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Russian Federation
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St. Petersburg
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Russian Federation
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St.-Petersburg
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Russian Federation
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Syktyvkar
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Spain
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Barcelona N/a
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Spain
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L'hospitalet De Llobregat
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Spain
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Madrid
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Spain
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Pamplona N/a
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Spain
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Salamanca
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Sweden
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Göteborg
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Sweden
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Lund
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Sweden
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Stockholm
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Taiwan
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Changhua County
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kayseri
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Ukraine
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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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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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United Kingdom
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Plymouth
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United Kingdom
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Sheffield
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United Kingdom
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Southampton
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pharmacyclics LLC.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01804686
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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/NCT01804686