Spots Global Cancer Trial Database for A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Official Title: A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Study ID: NCT01578707
Study Description
Brief Summary: The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Detailed Description: Study PCYC-1112-CA is a randomized, multicenter, open-label, phase 3 study of the Bruton's Tyrosine Kinase (BTK) inhibitor Ibrutinib (PCI-32765) versus Ofatumumab in patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Patients randomized to the ofatumumab arm may be considered to receive next subsequent therapy with ibrutinib.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site #408, La Jolla, California, United States
Site #377, Los Angeles, California, United States
Site #403, Santa Maria, California, United States
Site #038, Stanford, California, United States
Site #411, Norwalk, Connecticut, United States
Site #107, Marietta, Georgia, United States
Site # 379, Evansville, Indiana, United States
Site # 390, Boston, Massachusetts, United States
Site # 391, Boston, Massachusetts, United States
Site # 349, Boston, Massachusetts, United States
Site # 130, Detroit, Michigan, United States
Site # 406, Rochester, Minnesota, United States
Site # 059, New Brunswick, New Jersey, United States
Site # 350, New Hyde Park, New York, United States
Site # 200, New York, New York, United States
Site # 127, Rochester, New York, United States
Site # 197, Cincinnati, Ohio, United States
Site # 217, Columbus, Ohio, United States
Site # 402, Philadelphia, Pennsylvania, United States
Site # 396, Greenville, South Carolina, United States
Site # 410, Nashville, Tennessee, United States
Site # 032, Houston, Texas, United States
Site # 381, Laredo, Texas, United States
Site # 210, Charlottesville, Virginia, United States
Site # 404, Seattle, Washington, United States
Site # 500, St. Leonards, New South Wales, Australia
Site # 503, Brisbane, Queensland, Australia
Site # 199, East Melbourne, Victoria, Australia
Site # 501, Fitzroy, Victoria, Australia
Site # 502, Nedlands, Western Australia, Australia
Site # 509, Graz, , Austria
Site # 508, Linz, , Austria
Site # 504, Salzburg, , Austria
Site # 505, Vienna, , Austria
Site # 506, Wein, , Austria
Site # 507, Wels, , Austria
Site # 393, Antwerpen, , Belgium
Site # 519, Argenteuil, , France
Site # 511, Bobigny, , France
Site # 515, Bordeaux, , France
Site # 516, Caen, , France
Site # 513, Clermont Ferrand, , France
Site # 510, Marseille, , France
Site # 520, Nantes, , France
Site # 518, Rennes, , France
Site # 517, Vandœuvre-lès-Nancy, , France
Site # 570, Dublin, , Ireland
Site # 528, Dublin, , Ireland
Site # 096, Galway, , Ireland
Site # 522, Milano, , Italy
Site # 523, Milano, , Italy
Site # 526, Milano, , Italy
Site # 524, Modena, , Italy
Site # 527, Padova, , Italy
Site # 529, Gdansk, , Poland
Site # 531, Lodz, , Poland
Site # 535, Barcelona, , Spain
Site # 534, Barcelona, , Spain
Site # 533, Barcelona, , Spain
Site # 539, Coruna, , Spain
Site # 540, Madrid, , Spain
Site # 537, Madrid, , Spain
Site # 536, Madrid, , Spain
Site # 538, Pamplona, , Spain
Site # 549, Colchester, Essex, United Kingdom
Site # 543, Sutton, Surrey, United Kingdom
Site # 551, Bournemouth, , United Kingdom
Site # 553, Canterbury, , United Kingdom
Site # 546, Cardiff, , United Kingdom
Site # 554, Headington, , United Kingdom
Site # 550, Leeds, , United Kingdom
Site # 552, Liverpool, , United Kingdom
Site # 544, London, , United Kingdom
Site # 548, Nottingham, , United Kingdom
Site # 545, Southampton, , United Kingdom
Site # 541, Withington, , United Kingdom
Contact Details
Name: Anita Szoke, MD
Affiliation: Pharmacyclics LLC.
Role: STUDY_DIRECTOR
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