Chronic Lymphocytic Leukemia Clinical Trial
A Long-term Extension Study of PCI-32765 (Ibrutinib)
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.
Full 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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 162 Locations for this study
Duarte California, 91010, United States
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Stanford California, 94305, United States
Stanford California, 94305, United States
Norwalk Connecticut, 06850, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60611, United States
Goshen Indiana, 46526, United States
Westwood Kansas, 66205, United States
Louisville Kentucky, 40207, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Battle Creek Michigan, 49016, United States
Detroit Michigan, 48201, United States
Saint Louis Missouri, 63110, United States
Lebanon New Hampshire, 03756, United States
Hackensack New Jersey, 07601, United States
New York New York, 10021, United States
New York New York, 10065, United States
Goldsboro North Carolina, 27534, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97227, United States
Philadelphia Pennsylvania, 19104, United States
Sioux Falls South Dakota, 57105, United States
Houston Texas, 77030, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98109, United States
Morgantown West Virginia, 26506, United States
Madison Wisconsin, 53705, United States
Ciudad Autonoma Buenos Aires , C1431, Argentina
Ciudad de Buenos Aires , C1114, Argentina
Adelaide , 5000, Australia
Coburg , 3058, Australia
Concord , 2139, Australia
Heidelberg , 3084, Australia
Melbourne , 3000, Australia
Perth , 6847, Australia
Prahran , 3181, Australia
Wahroonga , 2076, Australia
Antwerp , 2650, Belgium
Brugge , 8000, Belgium
Brussels , 1200, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Yvoir , 5530, Belgium
Rio De Janeiro , 20231, Brazil
Salvador , 40050, Brazil
Sao Paulo , 01236, Brazil
Montreal Quebec, H3T 1, Canada
Beijing , 10004, China
Beijing , 10008, China
Beijing , , China
Chengdu , 61004, China
Fuzhou , 35000, China
Guangzhou , 51006, China
Hangzhou , 31000, China
Shanghai , 20002, China
Shanxi , , China
Suzhou, Jaiangsu , , China
Tianjin , 30007, China
Wuhan , 43002, China
Bogota , , Colombia
Floridablanca , 68100, Colombia
Brno , 625 0, Czechia
Praha 10 , 100 3, Czechia
Praha 2 , 128 0, Czechia
Creteil , 94010, France
Mulhouse , 68100, France
Paris cedex 15 , 75743, France
Paris , 75010, France
Pessac , 33604, France
Pierre Benite , 69310, France
Tours , 37044, France
Berlin , 13589, Germany
Dresden , 01307, Germany
Essen , 45122, Germany
Heidelberg , 69120, Germany
Homburg/Saar , 66424, Germany
Magdeburg , 39104, Germany
Marburg , 35037, Germany
Ulm , 89081, Germany
Athens , 115 2, Greece
Thessalonikis , 570 1, Greece
Budapest N/a , 1083, Hungary
Szeged , 6725, Hungary
Dublin , 00000, Ireland
Afula , , Israel
Hadera , 38100, Israel
Haifa , 31096, Israel
Petah Tikva , 49414, Israel
Ramat-Gan , 52621, Israel
Tel Aviv , 64239, Israel
Milano , 20162, Italy
Roma , 00161, Italy
Torino , 10126, Italy
Bunkyo-ku , 113-8, Japan
Hiroshima-shi , 734-8, Japan
Sapporo-shi , 060-8, Japan
Goyang-Si , 10408, Korea, Republic of
Seoul , 06591, Korea, Republic of
Oaxaca , 68000, Mexico
Amsterdam , 1081 , Netherlands
Brzozow , 36-20, Poland
Chorzów , 41-50, Poland
Gdansk , 80-95, Poland
Krakow , 30-51, Poland
Opole , 45-06, Poland
Slupsk , 76-20, Poland
Wroclaw , 50-36, Poland
Lisboa , 1600, Portugal
Lisbon , 1649-, Portugal
Porto , 42000, Portugal
San Juan , 00919, Puerto Rico
Arkhangelsk , 16304, Russian Federation
Chelyabinsk , 45408, Russian Federation
Dzerzhinsk , 60601, Russian Federation
Moscow N/a , 11547, Russian Federation
Moscow , 12528, Russian Federation
Nizhni Novgorod , 60312, Russian Federation
Obninsk , 24902, Russian Federation
Perm , 61407, Russian Federation
Petrozavodsk , 18501, Russian Federation
Rostov-Na-Donu , 34403, Russian Federation
Ryazan , 39003, Russian Federation
Saint , 19429, Russian Federation
Samara , 44309, Russian Federation
Sankt-Peterburg , 19734, Russian Federation
Sochi , 35405, Russian Federation
St. Petersburg , 19825, Russian Federation
St.-Petersburg , 19302, Russian Federation
Syktyvkar , 16790, Russian Federation
Barcelona N/a , 00000, Spain
L'hospitalet De Llobregat , 08907, Spain
Madrid , 28006, Spain
Madrid , 28007, Spain
Madrid , 28031, Spain
Madrid , 28040, Spain
Pamplona N/a , 31008, Spain
Salamanca , 37007, Spain
Göteborg , SE-41, Sweden
Lund , 22185, Sweden
Stockholm , 171 7, Sweden
Changhua County , 500, Taiwan
Ankara , 6590, Turkey
Istanbul , 34365, Turkey
Istanbul , 34390, Turkey
Izmir , 35340, Turkey
Kayseri , 38039, Turkey
Cherkasy , 18009, Ukraine
Dnepropetrovsk , 49102, Ukraine
Kharkiv , 61024, Ukraine
Khmelnitskiy , 29000, Ukraine
Kiev , 03115, Ukraine
Lviv , 79044, Ukraine
Vinnitsa , 21018, Ukraine
Birmingham , B15 2, United Kingdom
Bournemouth , BH7 7, United Kingdom
Colchester , CO4 5, United Kingdom
Glasgow , G12 0, United Kingdom
Leeds , LS9 7, United Kingdom
Leicester , LE1 5, United Kingdom
London , EC1A , United Kingdom
London , NW1 2, United Kingdom
London , SE5 9, United Kingdom
Manchester , 00000, United Kingdom
Nottingham , NG5 1, United Kingdom
Plymouth , PL6 8, United Kingdom
Sheffield , S10 2, United Kingdom
Southampton , SO16 , United Kingdom
Sutton , SM2 5, United Kingdom
How clear is this clinincal trial information?