Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT01804686

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Led by Janssen Research & Development, LLC · Updated on 2026-05-08

700

Participants Needed

175

Research Sites

729 weeks

Total Duration

On this page

Sponsors

J

Janssen Research & Development, LLC

Lead Sponsor

P

Pharmacyclics LLC.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants currently enrolled in a completed ibrutinib clinical study with at least 6 months of ibrutinib treatment, actively receiving single-agent ibrutinib; or participants from a randomized ibrutinib study who crossed over to ibrutinib treatment (less than 6 months prior treatment allowed with more safety checks); or participants in study PCI-32765LYM1002 actively receiving ibrutinib alone or with nivolumab
  • Investigator assesses benefits of continued ibrutinib therapy outweigh risks
  • Agreement to use effective contraception as defined in the protocol
  • Negative pregnancy test (blood or urine) at screening
Not Eligible

You will not qualify if you...

  • Need for anticoagulation treatment with warfarin or equivalent vitamin K antagonists
  • Need for treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors unless approved by the sponsor
  • Any condition or situation that the investigator believes poses significant risk, could affect study results, or interfere with participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 175 locations

1

City of Hope Cancer Center

Duarte, California, United States, 91010

Completed

2

University of California San Diego Medical Center

La Jolla, California, United States, 92093

Completed

3

University of California Los Angeles

Los Angeles, California, United States, 90095

Completed

4

St. Joseph Hospital Center for Cancer Prevention and Treatment

Orange, California, United States, 92868

Actively Recruiting

5

Stanford University Medical Center

Stanford, California, United States, 94305

Completed

6

Stanford University

Stanford, California, United States, 94305

Completed

7

Norwalk Medical Group

Norwalk, Connecticut, United States, 06850

Completed

8

Northwest Georgia Oncology Centers PC

Marietta, Georgia, United States, 30060

Completed

9

Northwestern University Hospital

Chicago, Illinois, United States, 60611

Completed

10

Indiana University

Goshen, Indiana, United States, 46526

Completed

11

Kansas University Medical Center

Westwood, Kansas, United States, 66205

Completed

12

Louisville Oncology Suburban - Norton Cancer Institute

Louisville, Kentucky, United States, 40207

Completed

13

Dana Farber Cancer Center

Boston, Massachusetts, United States, 02215

Completed

14

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States, 48109

Completed

15

Battle Creek Health Systm

Battle Creek, Michigan, United States, 49016

Completed

16

Karmanos Cancer Institute - Wayne State University

Detroit, Michigan, United States, 48201

Completed

17

Washington University

St Louis, Missouri, United States, 63110

Completed

18

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

Completed

19

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Completed

20

Weill Medical College of Cornell University

New York, New York, United States, 10021

Completed

21

Memorial Sloan-Kettering Cancer Center

New York, New York, United States, 10065

Completed

22

Southeastern Medical Oncology Center

Goldsboro, North Carolina, United States, 27534

Completed

23

The Ohio State University- James Cancer Hospital

Columbus, Ohio, United States, 43210

Actively Recruiting

24

Willamette Valley Cancer Center

Eugene, Oregon, United States, 97401

Actively Recruiting

25

Kaiser Permanente

Portland, Oregon, United States, 97227

Completed

26

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States, 19104

Completed

27

Avera Medical Group

Sioux Falls, South Dakota, United States, 57105

Actively Recruiting

28

MD Anderson Cancer Center - University of Texas

Houston, Texas, United States, 77030

Completed

29

University of Virginia

Charlottesville, Virginia, United States, 22908

Completed

30

University of Washington

Seattle, Washington, United States, 98109

Completed

31

West Virginia University

Morgantown, West Virginia, United States, 26506

Completed

32

University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research

Madison, Wisconsin, United States, 53705

Completed

33

CEMIC Saavedra

Ciudad Autonoma Buenos Aires, Argentina, C1431

Active, Not Recruiting

34

Fundaleu

Ciudad de Buenos Aires, Argentina, C1114AAP

Completed

35

Royal Adelaide Hospital

Adelaide, Australia, 5000

Active, Not Recruiting

36

John Fawkner Cancer Trial Centre

Coburg, Australia, 3058

Completed

37

Concord Hospital

Concord, Australia, 2139

Completed

38

Austin Health

Heidelberg, Australia, 3084

Completed

39

Peter MacCallum Cancer Centre

Melbourne, Australia, 3000

Completed

40

Royal Perth Hospital

Perth, Australia, 6847

Completed

41

Alfred Hospital

Prahran, Australia, 3181

Completed

42

Adventist Health Care Limited trading as San Clinical Trials Unit

Wahroonga, Australia, 2076

Actively Recruiting

43

UZA

Antwerp, Belgium, 2650

Completed

44

A.Z. Sint Jan

Bruges, Belgium, 8000

Completed

45

UCL - Saint Luc

Brussels, Belgium, 1200

Completed

46

UZ Gent - departement oncologie

Ghent, Belgium, 9000

Completed

47

UZ Leuven Gasthuisberg

Leuven, Belgium, 3000

Completed

48

UCL Mont-Godinne

Yvoir, Belgium, 5530

Actively Recruiting

49

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, Brazil, 20231 050

Completed

50

Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel

Salvador, Brazil, 40050 410

Completed

51

Instituto de Ensino e Pesquisa São Lucas

São Paulo, Brazil, 01236-030

Completed

52

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Completed

53

Peking University People's Hospital

Beijing, China, 100044

Actively Recruiting

54

Peking University Third Hospital

Beijing, China, 100083

Actively Recruiting

55

Peking University First Hospital

Beijing, China

Completed

56

West China Hospital Sichuan University

Chengdu, China, 610041

Actively Recruiting

57

Fujian Medical University

Fuzhou, China, 350001

Completed

58

Sun Yat-sen University Cancer Hospital

Guangzhou, China, 510060

Completed

59

Zhejiang University First Hospital

Hangzhou, China, 310003

Actively Recruiting

60

Ruijin Hospital

Shanghai, China, 200025

Completed

61

Tangdu hospital the Fourth Military Medical

Shanxi, China, 710038

Actively Recruiting

62

The First Affliated Hospital of Soochow University

Suzhou, China

Actively Recruiting

63

The Institute of Hematological disease

Tianjin, China, 300070

Completed

64

Wuhan Union Hospital

Wuhan, China, 430023

Completed

65

Fundacion Santa Fe

Bogotá, Colombia

Completed

66

Fundacion Oftalmologica de Santander - FOSCAL

Floridablanca, Colombia, 681002

Completed

67

Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

Brno, Czechia, 625 00

Completed

68

Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika

Prague, Czechia, 100 34

Completed

69

Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

Prague, Czechia, 128 08

Completed

70

Hopital Henri Mondor

Créteil, France, 94010

Completed

71

Hôpital E. Muller

Mulhouse, France, 68100

Completed

72

HOPITAL SAINT LOUIS - Hematology / Oncology

Paris, France, 75010

Completed

73

Hopital Necker Enfants Malades

Paris, France, 75743

Completed

74

Hopital Haut Leveque Service Maladie Du Sang

Pessac, France, 33604

Completed

75

CH LYON SUD - Hematology

Pierre-Bénite, France, 69310

Completed

76

CHU de Tours

Tours, France, 37044

Active, Not Recruiting

77

Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany

Berlin, Germany, 13589

Completed

78

Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus

Dresden, Germany, 01307

Completed

79

Universitätsklinikum Essen; Klinik f. Hämatologie- Germany

Essen, Germany, 45122

Completed

80

Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie

Giessen, Germany, 35592

Actively Recruiting

81

Universitätsklinikum Heidelberg Med. Klinik IV

Heidelberg, Germany, 69120

Completed

82

Universitätsklinikum des Saarlandes

Homburg/Saar, Germany, 66424

Completed

83

Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany

Magdeburg, Germany, 39104

Completed

84

OnkoNet Marburg GmbH

Marburg, Germany, 35037

Completed

85

Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany

Ulm, Germany, 89081

Completed

86

Laiko General Hospital - 1st department of Internal Medicine

Athens, Greece, 115 27

Completed

87

G Papanikolaou Hospital of Thessaloniki

Thessalonikis, Greece, 570 10

Completed

88

Semmelweis Egyetem, I. Belgyogyaszati Klinika

Budapest, Hungary, 1083

Completed

89

Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika

Szeged, Hungary, 6725

Completed

90

St James's Hospital

Dublin, Ireland, 00000

Completed

91

Haemek Medical Center

Afula, Israel

Completed

92

Hillel Yaffe Medical Center - Oncology

Hadera, Israel, 38100

Actively Recruiting

93

Rambam Health Care Campus

Haifa, Israel, 31096

Completed

94

Rabin Medical Center Beilinson Campus

Petah Tikva, Israel, 4941492

Completed

95

Sheba Medical Center

Ramat Gan, Israel, 52621

Completed

96

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

Actively Recruiting

97

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy, 20162

Completed

98

DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''

Roma, Italy, 00161

Completed

99

A.O.Citta della Salute e della Scienza di Torino

Torino, Italy, 10126

Completed

100

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Bunkyō City, Japan, 113 8677

Completed

101

Hiroshima University Hospital

Hiroshima, Japan, 734 8551

Actively Recruiting

102

Oaxaca Site Management Organization S.C.

Oaxaca City, Mexico, 68000

Completed

103

VU medisch centrum - Afd.Interne - INT

Amsterdam, Netherlands, 1081 HV

Completed

104

Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza

Brzozów, Poland, 36-200

Completed

105

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

Chorzów, Poland, 41-500

Completed

106

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80 952

Actively Recruiting

107

Pratia MCM Krakow

Krakow, Poland, 30 510

Actively Recruiting

108

Oddzial Hematologii

Opole, Poland, 45-061

Completed

109

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

Słupsk, Poland, 76-200

Completed

110

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, Poland, 02-781

Actively Recruiting

111

Katedra I Klinika Hematologii Nowotworow Krwi I Transplantacji Szpiku

Wroclaw, Poland, 50 367

Actively Recruiting

112

Instituto Portugues de Oncologia Lisboa

Lisbon, Portugal, 1600

Completed

113

Hospital De Santa Maria

Lisbon, Portugal, 1649-035

Completed

114

Instituto Portugues de Oncologia Porto

Porto, Portugal, 4200072

Active, Not Recruiting

115

Auxilio Mutuo Cancer Center

San Juan, Puerto Rico, 00919

Actively Recruiting

116

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, Russia, 163045

Completed

117

Chelyabinsk Regiona Onc. Center

Chelyabinsk, Russia, 454087

Completed

118

Emergency Hospital of Dzerzhinsk

Dzerzhinsk, Russia, 606019

Completed

119

Cancer Research Center

Moscow, Russia, 115478

Completed

120

S.P. Botkin Moscow City Clinical Hospital

Moscow, Russia, 125284

Actively Recruiting

121

Regional Clinical Hospital n.a.Semashko

Nizhny Novgorod, Russia, 603126

Actively Recruiting

122

Medical Scientific Radiology - Center

Obninsk, Russia, 249020

Completed

123

Perm Medical Sanitary Unit#1

Perm, Russia, 614078

Completed

124

Republican Hospital named by V.A.Baranova

Petrozavodsk, Russia, 185019

Actively Recruiting

125

Rostov Research Institute of Oncology

Rostov-on-Don, Russia, 344037

Completed

126

Ryazan Regional Clinical Hospital

Ryazan, Russia, 390039

Actively Recruiting

127

Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, Russia, 193024

Actively Recruiting

128

Federal Center of Heart, Blood and Endocrinology

Saint Petersburg, Russia, 197341

Actively Recruiting

129

City Clinical Oncology Dispensary

Saint Petersburg, Russia, 198255

Completed

130

Leningrad region clinical hospital

Saint, Russia, 194291

Completed

131

Samara Region Clinical Hospital

Samara, Russia, 443095

Completed

132

Oncological dispensary #2

Sochi, Russia, 354057

Actively Recruiting

133

Oncology Dispensary of Komi Republic

Syktyvkar, Russia, 167904

Completed

134

National Cancer Center

Goyang-si, South Korea, 10408

Completed

135

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, South Korea, 06591

Actively Recruiting

136

Hospital Vall d'Hebron

Barcelona, Spain, 00000

Actively Recruiting

137

Inst. Cat. Doncologia-H Duran I Reynals

L'Hospitalet de Llobregat, Spain, 08907

Completed

138

Hosp. Univ. de La Princesa

Madrid, Spain, 28006

Completed

139

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain, 28007

Completed

140

Hosp. Univ. Infanta Leonor

Madrid, Spain, 28031

Completed

141

Fundacion Jimenez Diaz

Madrid, Spain, 28040

Completed

142

Clinica Universitaria de Navarra

Pamplona, Spain, 31008

Completed

143

Hospital Clinico Universitario Salamanca

Salamanca, Spain, 37007

Actively Recruiting

144

Sahlgrenska University hospital, Hematology Dept

Gothenburg, Sweden, SE-413 45

Completed

145

Skanes universitetssjukhus

Lund, Sweden, 22185

Completed

146

Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm

Stockholm, Sweden, 171 76

Completed

147

Changhua Cristian Hospital

Changhua County, Taiwan, 500

Completed

148

Ankara University

Ankara, Turkey (Türkiye), 6590

Completed

149

American Hospital

Istanbul, Turkey (Türkiye), 34365

Completed

150

Istanbul University

Istanbul, Turkey (Türkiye), 34390

Completed

151

Dokuz Eylul Universitesi Tip Fakultesi

Izmir, Turkey (Türkiye), 35340

Completed

152

Erciyes University

Kayseri, Turkey (Türkiye), 38039

Completed

153

Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

Cherkasy, Ukraine, 18009

Active, Not Recruiting

154

Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

Dnipro, Ukraine, 49102

Completed

155

SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine

Kharkiv, Ukraine, 61024

Completed

156

Khmelnitskiy Regional Hospital, Hematology Department

Khmelnitskiy, Ukraine, 29000

Completed

157

State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine

Kiev, Ukraine, 03115

Completed

158

Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine

Lviv, Ukraine, 79044

Active, Not Recruiting

159

Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

Vinnitsa, Ukraine, 21018

Completed

160

University Hospitals Birmingham NHS Trust,

Birmingham, United Kingdom, B15 2TH

Completed

161

Royal Bournemouth Hospital

Bournemouth, United Kingdom, BH7 7DW

Completed

162

Colchester Hospital University NHS

Colchester, United Kingdom, CO4 5JL

Completed

163

Beatson West Of Scotland Cancer Centre

Glasgow, United Kingdom, G12 0YN

Completed

164

St James's Institute of Oncology

Leeds, United Kingdom, LS9 7TF

Completed

165

Leicester Royal Infirmary - Haematology

Leicester, United Kingdom, LE1 5WW

Completed

166

St Bartholomew's Hospital - Dept of Haematology

London, United Kingdom, EC1A 7BE

Completed

167

University College London Hospitals NHSFT

London, United Kingdom, NW1 2BU

Completed

168

Kings College Hospital

London, United Kingdom, SE5 9RS

Completed

169

Christie Hospital

Manchester, United Kingdom, 00000

Completed

170

Freeman Hospital Newcastle upon Tyne Hosptials NHS Foundation Trust

Newcastle upon Tyne, United Kingdom, NE7 7DN

Actively Recruiting

171

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom, NG5 1PB

Completed

172

Derriford Hospital

Plymouth, United Kingdom, PL6 8DH

Completed

173

Royal Hallamshire Hospital

Sheffield, United Kingdom, S10 2JF

Completed

174

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Completed

175

Royal Marsden Hospital (Sutton)

Sutton, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

S

Study Contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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