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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01804686




Registration number
NCT01804686
Ethics application status
Date submitted
4/03/2013
Date registered
5/03/2013
Date last updated
27/06/2019

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
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
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PCI-32765 (Ibrutinib)

Experimental: PCI-32765 (Ibrutinib) -


Treatment: Drugs: PCI-32765 (Ibrutinib)
PCI-32765 (Ibrutinib) will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent PCI-32765 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 medication
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)

Eligibility
Key inclusion criteria
- Participants must be currently participating in a PCI-32765 clinical study considered
completed and have received at least 6 months of treatment with PCI-32765.

- At study entry, participants must be actively receiving treatment with single-agent
PCI-32765 or participants must have participated in a PCI-32765 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 PCI-32765 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

- Agrees to protocol-defined use of effective contraception

- Negative blood or urine pregnancy test at screening
Minimum age
18 Years
Maximum age
No limit
Gender
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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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 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
- Melbourne
Recruitment postcode(s) [6] 0 0
6847 - Perth
Recruitment postcode(s) [7] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Connecticut
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Missouri
Country [11] 0 0
United States of America
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New Hampshire
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United States of America
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New Jersey
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New York
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United States of America
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North Carolina
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Ohio
Country [16] 0 0
United States of America
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Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
West Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad de Buenos Aires
Country [24] 0 0
Belgium
State/province [24] 0 0
Antwerp
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Belgium
State/province [25] 0 0
Brugge
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Belgium
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Brussels
Country [27] 0 0
Belgium
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Gent
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Belgium
State/province [28] 0 0
Leuven
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Belgium
State/province [29] 0 0
Yvoir
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio de Janeiro
Country [31] 0 0
Brazil
State/province [31] 0 0
Salvador
Country [32] 0 0
Brazil
State/province [32] 0 0
Sao Paulo
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
China
State/province [34] 0 0
Beijing
Country [35] 0 0
China
State/province [35] 0 0
Chengdu
Country [36] 0 0
China
State/province [36] 0 0
Fuzhou
Country [37] 0 0
China
State/province [37] 0 0
Guangzhou
Country [38] 0 0
China
State/province [38] 0 0
Hangzhou
Country [39] 0 0
China
State/province [39] 0 0
Shanghai
Country [40] 0 0
China
State/province [40] 0 0
Shanxi
Country [41] 0 0
China
State/province [41] 0 0
Suzhou, Jaiangsu
Country [42] 0 0
China
State/province [42] 0 0
Tianjin
Country [43] 0 0
China
State/province [43] 0 0
Wuhan
Country [44] 0 0
Colombia
State/province [44] 0 0
Bogota
Country [45] 0 0
Colombia
State/province [45] 0 0
Floridablanca
Country [46] 0 0
Czechia
State/province [46] 0 0
Brno
Country [47] 0 0
Czechia
State/province [47] 0 0
Praha 10
Country [48] 0 0
Czechia
State/province [48] 0 0
Praha 2
Country [49] 0 0
France
State/province [49] 0 0
Creteil
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France
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Mulhouse
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France
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Paris cedex 15
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France
State/province [52] 0 0
Paris
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France
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Pessac
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France
State/province [54] 0 0
Pierre Benite
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France
State/province [55] 0 0
Tours
Country [56] 0 0
Germany
State/province [56] 0 0
Berlin
Country [57] 0 0
Germany
State/province [57] 0 0
Dresden
Country [58] 0 0
Germany
State/province [58] 0 0
Essen
Country [59] 0 0
Germany
State/province [59] 0 0
Heidelberg
Country [60] 0 0
Germany
State/province [60] 0 0
Homburg/Saar
Country [61] 0 0
Germany
State/province [61] 0 0
Magdeburg
Country [62] 0 0
Germany
State/province [62] 0 0
Marburg
Country [63] 0 0
Germany
State/province [63] 0 0
Ulm
Country [64] 0 0
Greece
State/province [64] 0 0
Athens
Country [65] 0 0
Greece
State/province [65] 0 0
Thessalonikis
Country [66] 0 0
Hungary
State/province [66] 0 0
Budapest N/a
Country [67] 0 0
Hungary
State/province [67] 0 0
Szeged
Country [68] 0 0
Ireland
State/province [68] 0 0
Dublin
Country [69] 0 0
Israel
State/province [69] 0 0
Afula
Country [70] 0 0
Israel
State/province [70] 0 0
Hadera
Country [71] 0 0
Israel
State/province [71] 0 0
Haifa
Country [72] 0 0
Israel
State/province [72] 0 0
Petah Tikva
Country [73] 0 0
Israel
State/province [73] 0 0
Ramat-Gan
Country [74] 0 0
Israel
State/province [74] 0 0
Tel Aviv
Country [75] 0 0
Italy
State/province [75] 0 0
Milano
Country [76] 0 0
Italy
State/province [76] 0 0
Roma
Country [77] 0 0
Italy
State/province [77] 0 0
Torino
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Goyang-Si
Country [79] 0 0
Korea, Republic of
State/province [79] 0 0
Seoul
Country [80] 0 0
Mexico
State/province [80] 0 0
Oaxaca
Country [81] 0 0
Netherlands
State/province [81] 0 0
Amsterdam
Country [82] 0 0
Poland
State/province [82] 0 0
Brzozow
Country [83] 0 0
Poland
State/province [83] 0 0
Chorzów
Country [84] 0 0
Poland
State/province [84] 0 0
Gdansk
Country [85] 0 0
Poland
State/province [85] 0 0
Krakow
Country [86] 0 0
Poland
State/province [86] 0 0
Opole
Country [87] 0 0
Poland
State/province [87] 0 0
Slupsk
Country [88] 0 0
Poland
State/province [88] 0 0
Wroclaw
Country [89] 0 0
Portugal
State/province [89] 0 0
Lisboa
Country [90] 0 0
Portugal
State/province [90] 0 0
Lisbon
Country [91] 0 0
Portugal
State/province [91] 0 0
Porto
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Arkhangelsk
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Chelyabinsk
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Dzerzhinsk
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Moscow N/a
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Moscow
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Nizhni Novgorod
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Obninsk
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Perm
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Petrozavodsk
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Rostov-Na-Donu
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Ryazan
Country [103] 0 0
Russian Federation
State/province [103] 0 0
Saint
Country [104] 0 0
Russian Federation
State/province [104] 0 0
Samara
Country [105] 0 0
Russian Federation
State/province [105] 0 0
Sochi
Country [106] 0 0
Russian Federation
State/province [106] 0 0
St. Petersburg
Country [107] 0 0
Russian Federation
State/province [107] 0 0
St.-Petersburg
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Syktyvkar
Country [109] 0 0
Spain
State/province [109] 0 0
Barcelona N/a
Country [110] 0 0
Spain
State/province [110] 0 0
L'hospitalet De Llobregat
Country [111] 0 0
Spain
State/province [111] 0 0
Madrid
Country [112] 0 0
Spain
State/province [112] 0 0
Pamplona N/a
Country [113] 0 0
Spain
State/province [113] 0 0
Salamanca
Country [114] 0 0
Sweden
State/province [114] 0 0
Göteborg
Country [115] 0 0
Sweden
State/province [115] 0 0
Lund
Country [116] 0 0
Sweden
State/province [116] 0 0
Stockholm
Country [117] 0 0
Taiwan
State/province [117] 0 0
Changhua County
Country [118] 0 0
Turkey
State/province [118] 0 0
Ankara
Country [119] 0 0
Turkey
State/province [119] 0 0
Istanbul
Country [120] 0 0
Turkey
State/province [120] 0 0
Izmir
Country [121] 0 0
Turkey
State/province [121] 0 0
Kayseri
Country [122] 0 0
Ukraine
State/province [122] 0 0
Cherkassy
Country [123] 0 0
Ukraine
State/province [123] 0 0
Dnepropetrovsk
Country [124] 0 0
Ukraine
State/province [124] 0 0
Kharkiv
Country [125] 0 0
Ukraine
State/province [125] 0 0
Khmelnitskiy
Country [126] 0 0
Ukraine
State/province [126] 0 0
Kiev
Country [127] 0 0
Ukraine
State/province [127] 0 0
Lviv
Country [128] 0 0
Ukraine
State/province [128] 0 0
Vinnitsa
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Birmingham
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Bournemouth
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Colchester
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Glasgow
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Leeds
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Leicester
Country [135] 0 0
United Kingdom
State/province [135] 0 0
London
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Manchester
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Nottingham
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Plymouth
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Sheffield
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Southampton
Country [141] 0 0
United Kingdom
State/province [141] 0 0
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 PCI-32765 (Ibrutinib) and to provide ongoing access to PCI-32765 for
participants who are currently enrolled in PCI-32765 studies that have been completed
according to the parent protocol, are actively receiving treatment with PCI-32765, and who
continue to benefit from PCI-32765 treatment.
Trial website
https://clinicaltrials.gov/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/show/NCT01804686