Back to resultsA Long-term Extension Study of PCI-32765 (Ibrutinib) (CAN3001)
Primary Purpose
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma
Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ibrutinib
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Chronic lymphocytic leukemia, Small lymphocytic lymphoma, Mantle cell lymphoma, Follicular lymphoma, Diffuse large B-cell lymphoma, PCI-32765, Ibrutinib, Bruton's tyrosine kinase inhibitor, IMBRUVICA, JNJ-54179060
Eligibility Criteria
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
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
Sites / Locations
- City of Hope Cancer Center
- University of California San Diego Medical Center
- University of California Los Angeles
- St. Joseph Hospital Center for Cancer Prevention and Treatment
- Stanford University Medical Center
- Stanford University
- Norwalk Medical Group
- Northwest Georgia Oncology Centers PC
- Northwestern University Hospital
- Indiana University
- Kansas University Medical Center
- Louisville Oncology Suburban - Norton Cancer Institute
- Dana Farber Cancer Center
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health Systm
- Karmanos Cancer Institute - Wayne State University
- Washington University
- Dartmouth-Hitchcock Medical Center
- Hackensack University Medical Center
- Weill Medical College of Cornell University
- Memorial Sloan-Kettering Cancer Center
- Southeastern Medical Oncology Center
- The Ohio State University- James Cancer Hospital
- Kaiser Permanente
- University of Pennsylvania Medical Center
- Avera Medical Group
- MD Anderson Cancer Center - University of Texas
- University of Virginia
- University of Washington
- West Virginia University
- University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research
- CEMIC Saavedra
- Fundaleu
- Royal Adelaide Hospital
- John Fawkner Cancer Trial Centre
- Concord Hospital
- Austin Health
- Peter MacCallum Cancer Institute
- Royal Perth Hospital
- Alfred Hospital
- Adventist Health Care Limited trading as San Clinical Trials Unit
- UZA
- A.Z. Sint Jan
- UCL - Saint Luc
- UZ Gent - departement oncologie
- UZ Leuven Gasthuisberg
- UCL Mont-Godinne
- Ministerio da Saude - Instituto Nacional do Cancer
- Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel
- Instituto de Ensino e Pesquisa São Lucas
- Jewish General Hospital
- Peking University People's Hospital
- Peking University Third Hospital
- Peking University First Hospital
- West China Hospital Sichuan University
- Fujian Medical University
- Sun Yat-sen University Cancer Hospital
- Zhejiang University First Hospital
- Ruijin Hospital
- Tangdu hospital the Fourth Military Medical
- The First Affliated Hospital of Soochow University
- The Institute of Hematological disease
- Wuhan Union Hospital
- Fundacion Santa Fe
- Fundacion Oftalmologica de Santander - FOSCAL
- Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika
- Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika
- Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
- Hopital Henri Mondor
- Hôpital E. Muller
- Hôpital Necker Enfants Malades
- HOPITAL SAINT LOUIS - Hematology / Oncology
- Hopital Haut Leveque Service Maladie Du Sang
- CH LYON SUD - Hematology
- CHU de Tours
- Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany
- Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus
- Universitätsklinikum Essen; Klinik f. Hämatologie- Germany
- Universitätsklinikum Heidelberg Med. Klinik IV
- Universitätsklinikum des Saarlandes
- Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany
- OnkoNet Marburg GmbH
- Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany
- Laiko General Hospital - 1st department of Internal Medicine
- 'G. Papanikolaou' Hospital of Thessaloniki
- Semmelweis Egyetem, I. Belgyogyaszati Klinika
- Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika
- St James's Hospital
- Haemek Medical Center
- Hillel Yaffe Medical Center - Oncology
- Rambam Health Care Campus
- Rabin Medical Center, Beilinson Campus
- Sheba Medical Center
- Tel Aviv Sourasky Medical Center
- ASST Grande Ospedale Metropolitano Niguarda
- DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''
- A.O.Citta della Salute e della Scienza di Torino
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
- Hiroshima University Hospital
- Hokkaido University Hospital
- National Cancer Center
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Oaxaca Site Management Organization S.C.
- VU medisch centrum - Afd.Interne - INT
- Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
- Uniwersyteckie Centrum Kliniczne
- Pratia MCM Krakow
- Oddzial Hematologii
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
- Katedra i Klinika Hematologii , Nowotworów Krwi i Transplantacji Szpiku
- Instituto Portugues de Oncologia
- Hospital De Santa Maria
- Instituto Portugues de Oncologia
- Auxilio Mutuo Cancer Center
- Arkhangelsk Regional Clinical Hospital
- Chelyabinsk Regiona Onc. Center
- Emergency Hospital of Dzerzhinsk
- Cancer Research Center
- S.P. Botkin Moscow City Clinical Hospital
- Regional Clinical Hospital n.a.Semashko
- Medical Scientific Radiology - Center
- Perm Medical Sanitary Unit#1
- Republican Hospital named by V.A.Baranova
- Rostov Research Institute of Oncology
- Ryazan Regional Clinical Hospital
- Leningrad region clinical hospital
- Samara Region Clinical Hospital
- Federal Center of Heart, Blood and Endocrinology
- Oncological dispensary #2
- City Clinical Oncology Dispensary
- Clinical Research Institute of Hematology and Transfusiology
- Oncology Dispensary of Komi Republic
- Hospital Vall d'Hebron
- Inst. Cat. Doncologia-H Duran I Reynals
- Hosp. Univ. de La Princesa
- Hosp. Gral. Univ. Gregorio Maranon
- Hosp. Univ. Infanta Leonor
- Fundacion Jimenez Diaz
- Clinica Universitaria de Navarra
- Hospital Clinico Universitario Salamanca
- Sahlgrenska University hospital, Hematology Dept
- Skanes universitetssjukhus
- Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm
- Changhua Cristian Hospital
- Ankara University
- American Hospital
- Istanbul University
- Dokuz Eylul Universitesi Tip Fakultesi
- Erciyes University
- Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
- Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
- SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine
- Khmelnitskiy Regional Hospital, Hematology Department
- State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine
- Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine
- Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
- University Hospitals Birmingham NHS Trust,
- Royal Bournemouth Hospital
- Colchester Hospital University NHS
- Beatson West Of Scotland Cancer Centre
- St James's Institute of Oncology
- Leicester Royal Infirmary - Haematology
- St Bartholomew's Hospital - Dept of Haematology
- University College London Hospitals NHSFT
- King's College Hospital
- Christie Hospital
- Nottingham University Hospitals NHS Trust
- Derriford Hospital
- Royal Hallamshire Hospital
- Southampton General Hospital
- Royal Marsden Hospital (Sutton)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ibrutinib
Arm Description
Outcomes
Primary Outcome Measures
Number of participants affected by an adverse event
Secondary Outcome Measures
Number of participants with change in disease status
Full Information
NCT ID
NCT01804686
First Posted
March 4, 2013
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
Collaborators
Pharmacyclics LLC.
1. Study Identification
Unique Protocol Identification Number
NCT01804686
Brief Title
A Long-term Extension Study of PCI-32765 (Ibrutinib)
Acronym
CAN3001
Official Title
A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 9, 2013 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
January 29, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
Pharmacyclics LLC.
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is an open-label (identity of assigned study drug will be known) study designed to collect long-term safety and efficacy data and provide ibrutinib access to participants in completed ibrutinib studies. PCI-32765 (Ibrutinib) is a first-in-class, potent, orally-administered, covalently-binding small molecule inhibitor of bruton's tyrosine kinase. "PCI-32765" and "ibrutinib" refer to the same molecule; hereafter, "ibrutinib" will be used. Participants will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the participant withdraws consent, alternative access to ibrutinib is available and feasible (example, participant assistance program or commercial source of ibrutinib), or for other reasons as defined in the protocol, or until the end of the study, whichever occurs earlier. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol. There is no formal hypothesis testing planned for this long-term extension study. Participants for whom alternative access to ibrutinib is not available and feasible can receive treatment with single-agent ibrutinib until end of study, which is defined as the time when all participants still receiving study treatment have transitioned to commercial or alternative access to ibrutinib, have stopped receiving ibrutinib treatment, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, Chronic Graft Versus Host Disease
Keywords
Chronic lymphocytic leukemia, Small lymphocytic lymphoma, Mantle cell lymphoma, Follicular lymphoma, Diffuse large B-cell lymphoma, PCI-32765, Ibrutinib, Bruton's tyrosine kinase inhibitor, IMBRUVICA, JNJ-54179060
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ibrutinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
PCI-32765
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants affected by an adverse event
Time Frame
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 Measure Information:
Title
Number of participants with change in disease status
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
St. Joseph Hospital Center for Cancer Prevention and Treatment
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Norwalk Medical Group
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06850
Country
United States
Facility Name
Northwest Georgia Oncology Centers PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern University Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana University
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Kansas University Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Louisville Oncology Suburban - Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Dana Farber Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Battle Creek Health Systm
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49016
Country
United States
Facility Name
Karmanos Cancer Institute - Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Southeastern Medical Oncology Center
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
The Ohio State University- James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Kaiser Permanente
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Avera Medical Group
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
MD Anderson Cancer Center - University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
CEMIC Saavedra
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1431
Country
Argentina
Facility Name
Fundaleu
City
Ciudad de Buenos Aires
ZIP/Postal Code
C1114AAP
Country
Argentina
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
John Fawkner Cancer Trial Centre
City
Coburg
ZIP/Postal Code
3058
Country
Australia
Facility Name
Concord Hospital
City
Concord
ZIP/Postal Code
2139
Country
Australia
Facility Name
Austin Health
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Peter MacCallum Cancer Institute
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
ZIP/Postal Code
6847
Country
Australia
Facility Name
Alfred Hospital
City
Prahran
ZIP/Postal Code
3181
Country
Australia
Facility Name
Adventist Health Care Limited trading as San Clinical Trials Unit
City
Wahroonga
ZIP/Postal Code
2076
Country
Australia
Facility Name
UZA
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
A.Z. Sint Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UCL - Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Gent - departement oncologie
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
UCL Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Ministerio da Saude - Instituto Nacional do Cancer
City
Rio De Janeiro
ZIP/Postal Code
20231-050
Country
Brazil
Facility Name
Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel
City
Salvador
ZIP/Postal Code
40050-410
Country
Brazil
Facility Name
Instituto de Ensino e Pesquisa São Lucas
City
Sao Paulo
ZIP/Postal Code
01236-030
Country
Brazil
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Name
West China Hospital Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Fujian Medical University
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
Sun Yat-sen University Cancer Hospital
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
Zhejiang University First Hospital
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Tangdu hospital the Fourth Military Medical
City
Shanxi
Country
China
Facility Name
The First Affliated Hospital of Soochow University
City
Suzhou, Jaiangsu
Country
China
Facility Name
The Institute of Hematological disease
City
Tianjin
ZIP/Postal Code
300070
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430023
Country
China
Facility Name
Fundacion Santa Fe
City
Bogota
Country
Colombia
Facility Name
Fundacion Oftalmologica de Santander - FOSCAL
City
Floridablanca
ZIP/Postal Code
681002
Country
Colombia
Facility Name
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hôpital E. Muller
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
Hôpital Necker Enfants Malades
City
Paris cedex 15
ZIP/Postal Code
75743
Country
France
Facility Name
HOPITAL SAINT LOUIS - Hematology / Oncology
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Haut Leveque Service Maladie Du Sang
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CH LYON SUD - Hematology
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
CHU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany
City
Berlin
ZIP/Postal Code
13589
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Essen; Klinik f. Hämatologie- Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsklinikum Heidelberg Med. Klinik IV
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66424
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
OnkoNet Marburg GmbH
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Laiko General Hospital - 1st department of Internal Medicine
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
'G. Papanikolaou' Hospital of Thessaloniki
City
Thessalonikis
ZIP/Postal Code
570 10
Country
Greece
Facility Name
Semmelweis Egyetem, I. Belgyogyaszati Klinika
City
Budapest N/a
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
00000
Country
Ireland
Facility Name
Haemek Medical Center
City
Afula
Country
Israel
Facility Name
Hillel Yaffe Medical Center - Oncology
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
A.O.Citta della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
City
Bunkyo-ku
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
National Cancer Center
City
Goyang-Si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Oaxaca Site Management Organization S.C.
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
VU medisch centrum - Afd.Interne - INT
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Pratia MCM Krakow
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Oddzial Hematologii
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Katedra i Klinika Hematologii , Nowotworów Krwi i Transplantacji Szpiku
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Instituto Portugues de Oncologia
City
Lisboa
ZIP/Postal Code
1600
Country
Portugal
Facility Name
Hospital De Santa Maria
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Instituto Portugues de Oncologia
City
Porto
ZIP/Postal Code
4200072
Country
Portugal
Facility Name
Auxilio Mutuo Cancer Center
City
San Juan
ZIP/Postal Code
00919
Country
Puerto Rico
Facility Name
Arkhangelsk Regional Clinical Hospital
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Chelyabinsk Regiona Onc. Center
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Emergency Hospital of Dzerzhinsk
City
Dzerzhinsk
ZIP/Postal Code
606019
Country
Russian Federation
Facility Name
Cancer Research Center
City
Moscow N/a
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
S.P. Botkin Moscow City Clinical Hospital
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Regional Clinical Hospital n.a.Semashko
City
Nizhni Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Medical Scientific Radiology - Center
City
Obninsk
ZIP/Postal Code
249020
Country
Russian Federation
Facility Name
Perm Medical Sanitary Unit#1
City
Perm
ZIP/Postal Code
614078
Country
Russian Federation
Facility Name
Republican Hospital named by V.A.Baranova
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Rostov Research Institute of Oncology
City
Rostov-Na-Donu
ZIP/Postal Code
344037
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Hospital
City
Ryazan
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Leningrad region clinical hospital
City
Saint
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Samara Region Clinical Hospital
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Federal Center of Heart, Blood and Endocrinology
City
Sankt-Peterburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Oncological dispensary #2
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
City Clinical Oncology Dispensary
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Clinical Research Institute of Hematology and Transfusiology
City
St.-Petersburg
ZIP/Postal Code
193024
Country
Russian Federation
Facility Name
Oncology Dispensary of Komi Republic
City
Syktyvkar
ZIP/Postal Code
167904
Country
Russian Federation
Facility Name
Hospital Vall d'Hebron
City
Barcelona N/a
ZIP/Postal Code
00000
Country
Spain
Facility Name
Inst. Cat. Doncologia-H Duran I Reynals
City
L'hospitalet De Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hosp. Univ. de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hosp. Gral. Univ. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hosp. Univ. Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona N/a
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clinico Universitario Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Sahlgrenska University hospital, Hematology Dept
City
Göteborg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
Skanes universitetssjukhus
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Changhua Cristian Hospital
City
Changhua County
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Ankara University
City
Ankara
ZIP/Postal Code
6590
Country
Turkey
Facility Name
American Hospital
City
Istanbul
ZIP/Postal Code
34365
Country
Turkey
Facility Name
Istanbul University
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Erciyes University
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
City
Dnepropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine
City
Kharkiv
ZIP/Postal Code
61024
Country
Ukraine
Facility Name
Khmelnitskiy Regional Hospital, Hematology Department
City
Khmelnitskiy
ZIP/Postal Code
29000
Country
Ukraine
Facility Name
State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov
City
Vinnitsa
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
University Hospitals Birmingham NHS Trust,
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Colchester Hospital University NHS
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Beatson West Of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
St James's Institute of Oncology
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary - Haematology
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
St Bartholomew's Hospital - Dept of Haematology
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
University College London Hospitals NHSFT
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
00000
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden Hospital (Sutton)
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Long-term Extension Study of PCI-32765 (Ibrutinib)
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