Chronic Lymphocytic Leukemia Clinical Trial
A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion
Summary
An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion
Full Description
This is a multicenter, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of ibrutinib in subjects with relapsed/refractory leukemia-cll/" >CLL or SLL with del 17p. All subjects will receive ibrutinib until disease progression or unacceptable toxicity occurs.
Eligibility Criteria
Key Inclusion Criteria:
Documentation of del (17p13.1)
Must have relapsed or refractory CLL/SLL after receiving at least 1 prior line of systemic therapy.
Measurable nodal disease by computed tomography (CT)
Key Exclusion Criteria:
History or current evidence of Richter's transformation or prolymphocytic leukemia
Prior hematologic stem cell transplantation <6 months from study enrollment or any ongoing GVHD
Prior exposure to ibrutinib
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There is 1 Location for this study
Phoenix Arizona, , United States
Duarte California, , United States
Greenbrae California, , United States
La Jolla California, , United States
Stanford California, , United States
Tampa Florida, , United States
Chicago Illinois, , United States
Boston Massachusetts, , United States
Ann Arbor Michigan, , United States
Rochester Minnesota, 55905, United States
St. Louis Missouri, , United States
Hackensack New Jersey, , United States
New Hyde Park New York, , United States
New York New York, , United States
Goldsboro North Carolina, , United States
Columbus Ohio, , United States
Toldedo Ohio, , United States
Houston Texas, , United States
Adelaide , , Australia
Coburg , , Australia
East Melbourne , , Australia
Fremantle , , Australia
Antwerp , , Belgium
Brugge , , Belgium
Brussels , , Belgium
Gent , , Belgium
Kortrijk , , Belgium
Leuven , , Belgium
Roeselare , , Belgium
Edmonton Alberta, , Canada
Cologne , , Germany
Dresden , , Germany
Heidelberg , , Germany
Munich , , Germany
Ulm , , Germany
Auckland , , New Zealand
Christchurch , , New Zealand
Goteborg , , Sweden
Lund , , Sweden
Stockholm , , Sweden
Ankara , , Turkey
Gaziantep , , Turkey
Istanbul , , Turkey
Izmir , , Turkey
Kayseri , , Turkey
Bournemouth , , United Kingdom
Glasgow , , United Kingdom
Leeds , , United Kingdom
Leicester , , United Kingdom
Liverpool , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
Newcastle upon Tyne , , United Kingdom
Oxford , , United Kingdom
Plymouth , , United Kingdom
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