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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT01804686

Collaborator

Pharmacyclics LLC. (Industry)

700

Enrollment

166

Locations

Arm

160.7

Anticipated Duration (Months)

4.2

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Diffuse Large B-cell Lymphoma Waldenstrom Macroglobulinemia Chronic Graft Versus Host Disease	Drug: Ibrutinib	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

Actual Study Start Date :

Sep 9, 2013

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Jan 29, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ibrutinib	Drug: 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. Other Names: PCI-32765

Arm

Intervention/Treatment

Experimental: Ibrutinib

Drug: 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.

Other Names:

PCI-32765

Outcome Measures

Primary Outcome Measures

Number of participants affected by an adverse event [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 Measures

Number of participants with change in disease status [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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope Cancer Center	Duarte	California	United States	91010
2	University of California San Diego Medical Center	La Jolla	California	United States	92093
3	University of California Los Angeles	Los Angeles	California	United States	90095
4	Stanford University Medical Center	Stanford	California	United States	94305
5	Stanford University	Stanford	California	United States	94305
6	Norwalk Medical Group	Norwalk	Connecticut	United States	06850
7	Northwest Georgia Oncology Centers PC	Marietta	Georgia	United States	30060
8	Northwestern University Hospital	Chicago	Illinois	United States	60611
9	Indiana University	Goshen	Indiana	United States	46526
10	Kansas University Medical Center	Westwood	Kansas	United States	66205
11	Louisville Oncology Suburban - Norton Cancer Institute	Louisville	Kentucky	United States	40207
12	Dana Farber Cancer Center	Boston	Massachusetts	United States	02215
13	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
14	Battle Creek Health Systm	Battle Creek	Michigan	United States	49016
15	Karmanos Cancer Institute - Wayne State University	Detroit	Michigan	United States	48201
16	Washington University	Saint Louis	Missouri	United States	63110
17	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
18	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
19	Weill Medical College of Cornell University	New York	New York	United States	10021
20	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
21	Southeastern Medical Oncology Center	Goldsboro	North Carolina	United States	27534
22	The Ohio State University- James Cancer Hospital	Columbus	Ohio	United States	43210
23	Kaiser Permanente	Portland	Oregon	United States	97227
24	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania	United States	19104
25	MD Anderson Cancer Center - University of Texas	Houston	Texas	United States	77030
26	University of Virginia	Charlottesville	Virginia	United States	22908
27	University of Washington	Seattle	Washington	United States	98109
28	West Virginia University	Morgantown	West Virginia	United States	26506
29	University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research	Madison	Wisconsin	United States	53705
30	Fundaleu	Ciudad de Buenos Aires		Argentina	C1114AAP
31	Royal Adelaide Hospital	Adelaide		Australia	5000
32	John Fawkner Cancer Trial Centre	Coburg		Australia	3058
33	Concord Hospital	Concord		Australia	2139
34	Austin Health	Heidelberg		Australia	3084
35	Peter MacCallum Cancer Institute	Melbourne		Australia	3000
36	Royal Perth Hospital	Perth		Australia	6847
37	Alfred Hospital	Prahran		Australia	3181
38	UZA	Antwerp		Belgium	2650
39	A.Z. Sint Jan	Brugge		Belgium	8000
40	UCL - Saint Luc	Brussels		Belgium	1200
41	UZ Gent - departement oncologie	Gent		Belgium	9000
42	UZ Leuven Gasthuisberg	Leuven		Belgium	3000
43	UCL Mont-Godinne	Yvoir		Belgium	5530
44	INCA - Instituto Nacional Do Cancer	Rio de Janeiro		Brazil	20231-050
45	Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel	Salvador		Brazil	40050-410
46	Instituto de Ensino E Pesquisa Sao Lucas	Sao Paulo		Brazil	01236-030
47	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
48	Peking University People's Hospital	Beijing		China	100044
49	Peking University Third Hospital	Beijing		China	100083
50	Peking University First Hospital	Beijing		China
51	West China Hospital Sichuan University	Chengdu		China	610041
52	Fujian Medical University	Fuzhou		China	350001
53	Sun Yat-sen University Cancer Hospital	Guangzhou		China	510060
54	Zhejiang University First Hospital	Hangzhou		China	310003
55	Ruijin Hospital	Shanghai		China	200025
56	Tangdu hospital the Fourth Military Medical	Shanxi		China
57	The First Affliated Hospital of Soochow University	Suzhou, Jaiangsu		China
58	The Institute of Hematological disease	Tianjin		China	300070
59	Wuhan Union Hospital	Wuhan		China	430023
60	Fundacion Santa Fe	Bogota		Colombia
61	Fundacion Oftalmologica de Santander - FOSCAL	Floridablanca		Colombia	681002
62	Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika	Brno		Czechia	625 00
63	Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika	Praha 10		Czechia	100 34
64	Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie	Praha 2		Czechia	128 08
65	Hopital Henri Mondor	Creteil		France	94010
66	Hôpital E. Muller	Mulhouse		France	68100
67	Hôpital Necker Enfants Malades	Paris cedex 15		France	75743
68	HOPITAL SAINT LOUIS - Hematology / Oncology	Paris		France	75010
69	Hopital Haut Leveque Service Maladie Du Sang	Pessac		France	33604
70	CH LYON SUD - Hematology	Pierre Benite		France	69310
71	CHU de Tours	Tours		France	37044
72	Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany	Berlin		Germany	13589
73	Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus	Dresden		Germany	01307
74	Universitätsklinikum Essen; Klinik f. Hämatologie- Germany	Essen		Germany	45122
75	Universitätsklinikum Heidelberg Med. Klinik IV	Heidelberg		Germany	69120
76	Universitätsklinikum des Saarlandes	Homburg/Saar		Germany	66424
77	Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany	Magdeburg		Germany	39104
78	OnkoNet Marburg GmbH	Marburg		Germany	35037
79	Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany	Ulm		Germany	89081
80	Laiko General Hospital - 1st department of Internal Medicine	Athens		Greece	115 27
81	'G. Papanikolaou' Hospital of Thessaloniki	Thessalonikis		Greece	570 10
82	Semmelweis Egyetem, I. Belgyogyaszati Klinika	Budapest N/a		Hungary	1083
83	Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika	Szeged		Hungary	6725
84	St James's Hospital	Dublin		Ireland	00000
85	Haemek Medical Center	Afula		Israel
86	Hillel Yaffe Medical Center - Oncology	Hadera		Israel	38100
87	Rambam Health Care Campus	Haifa		Israel	31096
88	Rabin Medical Center, Beilinson Campus	Petah Tikva		Israel	4941492
89	Sheba Medical Center	Ramat-Gan		Israel	52621
90	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	64239
91	ASST Grande Ospedale Metropolitano Niguarda	Milano		Italy	20162
92	DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''	Roma		Italy	00161
93	A.O.Citta della Salute e della Scienza di Torino	Torino		Italy	10126
94	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital	Bunkyo-ku		Japan	113-8677
95	Hokkaido University Hospital	Sapporo-shi		Japan	060-8648
96	National Cancer Center	Goyang-Si		Korea, Republic of	10408
97	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591
98	Oaxaca Site Management Organization S.C.	Oaxaca		Mexico	68000
99	VU medisch centrum - Afd.Interne - INT	Amsterdam		Netherlands	1081 HV
100	Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza	Brzozow		Poland	36-200
101	Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich	Chorzów		Poland	41-500
102	Uniwersyteckie Centrum Kliniczne	Gdansk		Poland	80-952
103	Pratia MCM Krakow	Krakow		Poland	30-510
104	Oddzial Hematologii	Opole		Poland	45-061
105	Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka	Slupsk		Poland	76-200
106	Katedra i Klinika Hematologii , Nowotworów Krwi i Transplantacji Szpiku	Wroclaw		Poland	50-367
107	Instituto Portugues de Oncologia	Lisboa		Portugal	1600
108	Hospital De Santa Maria	Lisbon		Portugal	1649-035
109	Instituto Portugues de Oncologia	Porto		Portugal	4200072
110	Arkhangelsk Regional Clinical Hospital	Arkhangelsk		Russian Federation	163045
111	Chelyabinsk Regiona Onc. Center	Chelyabinsk		Russian Federation	454087
112	Emergency Hospital of Dzerzhinsk	Dzerzhinsk		Russian Federation	606019
113	Cancer Research Center	Moscow N/a		Russian Federation	115478
114	S.P. Botkin Moscow City Clinical Hospital	Moscow		Russian Federation	125284
115	Regional Clinical Hospital n.a.Semashko	Nizhni Novgorod		Russian Federation	603126
116	Medical Scientific Radiology - Center	Obninsk		Russian Federation	249020
117	Perm Medical Sanitary Unit#1	Perm		Russian Federation	614078
118	Republican Hospital named by V.A.Baranova	Petrozavodsk		Russian Federation	185019
119	Rostov Research Institute of Oncology	Rostov-Na-Donu		Russian Federation	344037
120	Ryazan Regional Clinical Hospital	Ryazan		Russian Federation	390039
121	Leningrad region clinical hospital	Saint		Russian Federation	194291
122	Samara Region Clinical Hospital	Samara		Russian Federation	443095
123	Federal Center of Heart, Blood and Endocrinology	Sankt-Peterburg		Russian Federation	197341
124	Oncological dispensary #2	Sochi		Russian Federation	354057
125	City Clinical Oncology Dispensary	St. Petersburg		Russian Federation	198255
126	Clinical Research Institute of Hematology and Transfusiology	St.-Petersburg		Russian Federation	193024
127	Oncology Dispensary of Komi Republic	Syktyvkar		Russian Federation	167904
128	Hospital Vall d'Hebron	Barcelona N/a		Spain	00000
129	Inst. Cat. Doncologia-H Duran I Reynals	L'hospitalet De Llobregat		Spain	08907
130	Hosp. Univ. de La Princesa	Madrid		Spain	28006
131	Hosp. Gral. Univ. Gregorio Marañon	Madrid		Spain	28007
132	Hosp. Univ. Infanta Leonor	Madrid		Spain	28031
133	Fundacion Jimenez Diaz	Madrid		Spain	28040
134	Clinica Universitaria de Navarra	Pamplona N/a		Spain	31008
135	Hospital Clinico Universitario Salamanca	Salamanca		Spain	37007
136	Sahlgrenska University hospital, Hematology Dept	Göteborg		Sweden	SE-413 45
137	Skanes universitetssjukhus	Lund		Sweden	22185
138	Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm	Stockholm		Sweden	171 76
139	Changhua Cristian Hospital	Changhua County		Taiwan	500
140	Ankara University	Ankara		Turkey	6590
141	American Hospital	Istanbul		Turkey	34365
142	Istanbul University	Istanbul		Turkey	34390
143	Dokuz Eylul Universitesi Tip Fakultesi	Izmir		Turkey	35340
144	Erciyes University	Kayseri		Turkey	38039
145	Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'	Cherkasy		Ukraine	18009
146	Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center	Dnepropetrovsk		Ukraine	49102
147	SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine	Kharkiv		Ukraine	61024
148	Khmelnitskiy Regional Hospital, Hematology Department	Khmelnitskiy		Ukraine	29000
149	State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine	Kiev		Ukraine	03115
150	Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine	Lviv		Ukraine	79044
151	Vinnytsya Regional Clinical Hospital named after M.I.Pirogov	Vinnitsa		Ukraine	21018
152	University Hospitals Birmingham NHS Trust,	Birmingham		United Kingdom	B15 2TH
153	Royal Bournemouth Hospital	Bournemouth		United Kingdom	BH7 7DW
154	Colchester Hospital University NHS	Colchester		United Kingdom	CO4 5JL
155	Beatson West Of Scotland Cancer Centre	Glasgow		United Kingdom	G12 0YN
156	St James's Institute of Oncology	Leeds		United Kingdom	LS9 7TF
157	Leicester Royal Infirmary - Haematology	Leicester		United Kingdom	LE1 5WW
158	St Bartholomew's Hospital - Dept of Haematology	London		United Kingdom	EC1A 7BE
159	University College London Hospitals NHSFT	London		United Kingdom	NW1 2BU
160	King's College Hospital	London		United Kingdom	SE5 9RS
161	Christie Hospital	Manchester		United Kingdom	00000
162	Nottingham University Hospitals NHS Trust	Nottingham		United Kingdom	NG5 1PB
163	Derriford Hospital	Plymouth		United Kingdom	PL6 8DH
164	Royal Hallamshire Hospital	Sheffield		United Kingdom	S10 2JF
165	Southampton General Hospital	Southampton		United Kingdom	SO16 6YD
166	Royal Marsden Hospital (Sutton)	Sutton		United Kingdom	SM2 5PT