Chronic Lymphocytic Leukemia Clinical Trial

Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Summary

An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (leukemia-cll/" >CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Randomized in the parent study, PCYC-1115-CA
Informed consent for Study PCYC-1116-CA
IRC-confirmed PD in the parent study PCYC-1115-CA or closure of the parent study

Exclusion Criteria:

Disease progression involving the central nervous system (CNS) or transformation to another histology
Intervening chemotherapy, immunotherapy, or investigational agent specifically to treat CLL if administered before date of IRC confirmed progressive disease
In the 4 weeks before dosing: radiation therapy, major surgery, or receipt of an investigational drug
Requirement for treatment with a strong CYP3A inhibitor
Uncontrolled systemic infection or requirement for IV antibiotics
Noncompliance on the parent study(PCYC-1115-CA)

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

232

Study ID:

NCT01724346

Recruitment Status:

Completed

Sponsor:

Pharmacyclics LLC.

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There are 107 Locations for this study

See Locations Near You

Site Reference ID/Investigator #047
Duarte California, 91010, United States
Site Reference ID/Investigator #408
La Jolla California, 92093, United States
Site Reference ID/Investigator #720
Santa Rosa California, 95403, United States
Site Reference ID/Investigator #038
Stanford California, 94305, United States
Site Reference ID/Investigator #125
Atlanta Georgia, 30318, United States
Site Reference ID/Investigator #126
Chicago Illinois, 60637, United States
Site Reference ID/Investigator #071
Louisville Kentucky, 40207, United States
Site Reference ID/Investigator #307
Worcester Massachusetts, 01655, United States
Site Reference ID/Investigator #387
Ann Arbor Michigan, 48109, United States
Site Reference ID/Investigator #221
Saint Louis Missouri, 63110, United States
Site Reference ID/Investigator #712
Las Vegas Nevada, 89169, United States
Site Reference ID/Investigator #350
New Hyde Park New York, 11042, United States
Site Reference ID/Investigator #127
Rochester New York, 14642, United States
Site Reference ID/Investigator #656
Goldsboro North Carolina, 27534, United States
Site Reference ID/Investigator #734
Columbus Ohio, 43219, United States
Site Reference ID/Investigator #677
Portland Oregon, 97227, United States
Site Reference ID/Investigator #050
Pittsburgh Pennsylvania, 15232, United States
Site Reference ID/Investigator #032
Houston Texas, 77030, United States
Site Reference ID/Investigator #381
Laredo Texas, 78041, United States
Site Reference ID/Investigator #653
San Antonio Texas, 78229, United States
Site Reference ID/Investigator #404
Seattle Washington, 98109, United States
Site Reference ID/Investigator #731
Walla Walla Washington, 99362, United States
Site Reference ID/Investigator #654
Kogarah New South Wales, 2217, Australia
Site Reference ID/Investigator #503
Woolloongabba Queensland, 4102, Australia
Site Reference ID/Investigator #163
Bedford Park South Australia, 5042, Australia
Site Reference ID/Investigator #555
Hobart Tasmania, 7000, Australia
Site Reference ID/Investigator #193
Box Hill Victoria, 3128, Australia
Site Reference ID/Investigator #556
Clayton Victoria, 3168, Australia
Site Reference ID/Investigator #501
Fitzroy Victoria, 3065, Australia
Site Reference ID/Investigator #715
Frankston Victoria, 3199, Australia
Site Reference ID/Investigator #558
Geelong Victoria, 3220, Australia
Site Reference ID/Investigator #170
Heidelberg Victoria, 3084, Australia
Site Reference ID/Investigator #164
Bruxelles Brussells, 1200, Belgium
Site Reference ID/Investigator #727
Yvoir Namur, 5530, Belgium
Site Reference ID/Investigator #560
Gent Oost-Vlaanderen, 9000, Belgium
Site Reference ID/Investigator #559
Leuven Vlaams Brabant, 3000, Belgium
Site Reference ID/Investigator #628
Brugge West-Vlaanderen, 8000, Belgium
Site Reference ID/Investigator #561
Antwerpen , 2060, Belgium
Site Reference ID/Investigator #184
Brussells , 1000, Belgium
Site Reference ID/Investigator #157
Calgary Alberta, T2N 4, Canada
Site Reference ID/Investigator #018
Edmonton Alberta, T6G 1, Canada
Site Reference ID/Investigator #674
Guangzhou Guangdong, 51006, China
Site Reference ID/Investigator #671
Nanjing Jiangsu, 21002, China
Site Reference ID/Investigator #675
Hangzhou Zhejiang, 31003, China
Site Reference ID/Investigator #670
Beijing , 10014, China
Site Reference ID/Investigator #673
Beijing , 10019, China
Site Reference ID/Investigator #564
Hradec Kralove Kralovehradecky Kraj, 500 0, Czechia
Site Reference ID/Investigator #562
Brno , 625 0, Czechia
Site Reference ID/Investigator #566
Plzen-Lochotin , 304 6, Czechia
Site Reference ID/Investigator #572
Dublin , 7, Ireland
Site Reference ID/Investigator #570
Dublin , 8, Ireland
Site Reference ID/Investigator #571
Galway , ST4 6, Ireland
Site Reference ID/Investigator #573
Haifa , 31048, Israel
Site Reference ID/Investigator #576
Haifa , 31096, Israel
Site Reference ID/Investigator #577
Jerusalem , 91031, Israel
Site Reference ID/Investigator #578
Nahariya , 22100, Israel
Site Reference ID/Investigator #575
Petaẖ Tiqwa , 49100, Israel
Site Reference ID/Investigator #574
Ramat Gan , 52621, Israel
Site Reference ID/Investigator #583
Roma Lazio, 00161, Italy
Site Reference ID/Investigator #522
Rozzano Milano, 20089, Italy
Site Reference ID/Investigator #582
Novara Piemonte, 28100, Italy
Site Reference ID/Investigator #527
Padova Veneto, 35128, Italy
Site Reference ID/Investigator #580
Bologna , 40138, Italy
Site Reference ID/Investigator #584
Milano , 20122, Italy
Site Reference ID/Investigator #523
Milano , 20132, Italy
Site Reference ID/Investigator #581
Milano , 20162, Italy
Site Reference ID/Investigator #524
Modena , 41100, Italy
Site Reference ID/Investigator #589
Christchurch Canterbury, 8011, New Zealand
Site Reference ID/Investigator #586
Hamilton Waikato, 3240, New Zealand
Site Reference ID/Investigator #663
Auckland , 0622, New Zealand
Site Reference ID/Investigator #588
Auckland , 1023, New Zealand
Site Reference ID/Investigator #587
Wellington , 6021, New Zealand
Site Reference ID/Investigator #590
Lublin Lubelskie, 20-08, Poland
Site Reference ID/Investigator #592
Brzozowie Podkarpackie, 36.20, Poland
Site Reference ID/Investigator #591
Chorzow , 40, Poland
Site Reference ID/Investigator #529
Gdansk , 80-95, Poland
Site Reference ID/Investigator #531
Lodz , 93-51, Poland
Site Reference ID/Investigator #707
Ryazan , 39003, Russian Federation
Site Reference ID/Investigator #304
Yaroslavl , 15006, Russian Federation
Site Reference ID/Investigator #536
Majadahonda Madrid, 28222, Spain
Site Reference ID/Investigator #534
Barcelona , 08035, Spain
Site Reference ID/Investigator #533
Barcelona , 08036, Spain
Site Reference ID/Investigator #535
Barcelona , 08041, Spain
Site Reference ID/Investigator #604
Barcelona , 08908, Spain
Site Reference ID/Investigator #537
Madrid , 28050, Spain
Site Reference ID/Investigator #608
Ankara , 06500, Turkey
Site Reference ID/Investigator #606
Ankara , 06590, Turkey
Site Reference ID/Investigator #599
Istanbul , 34390, Turkey
Site Reference ID/Investigator #714
Izmir , 35040, Turkey
Site Reference ID/Investigator #601
Izmir , 35340, Turkey
Site Reference ID/Investigator #602
Kayseri , 38039, Turkey
Site Reference ID/Investigator #597
Cherkasy Cherkas'ka Oblast, 18009, Ukraine
Site Reference ID/Investigator #594
Dnipropetrovsk Dnipropetrovs'ka Oblast', 49102, Ukraine
Site Reference ID/Investigator #725
Kharkiv Kharkivs'ka Oblast, 61070, Ukraine
Site Reference ID/Investigator #596
Lviv L'vivs'ka Oblast, 79044, Ukraine
Site Reference ID/Investigator #598
Simferopol Respublika Krym, 95023, Ukraine
Site Reference ID/Investigator #595
Vinnytsia Vinnyts'ka Oblast, 21018, Ukraine
Site Reference ID/Investigator #724
Zhytomyr Zhytomyrs'ka Oblast', 10022, Ukraine
Site Reference ID/Investigator #551
Bournemouth Dorset, BH7 7, United Kingdom
Site Reference ID/Investigator #544
London England, SE5 9, United Kingdom
Site Reference ID/Investigator #668
Oxford England, OX3 7, United Kingdom
Site Reference ID/Investigator #549
Colchester Essex, CO4 5, United Kingdom
Site Reference ID/Investigator #607
Cardiff South Glamergon, CF14 , United Kingdom
Site Reference ID/Investigator #550
Leeds Yorkshire, LS9 7, United Kingdom
Site Reference ID/Investigator #721
Birmingham , B9 5S, United Kingdom
Site Reference ID/Investigator #548
Nottingham , NG5 1, United Kingdom
Site Reference ID/Investigator #367
Southampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

232

Study ID:

NCT01724346

Recruitment Status:

Completed

Sponsor:


Pharmacyclics LLC.

How clear is this clinincal trial information?

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