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
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Lead
Pharmacyclics LLC.
With
Janssen Research & Development, LLC
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 CLL or SLL with del 17p. All subjects will receive ibrutinib until disease progression or unacceptable toxicity occurs.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | 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