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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
Not Recruiting
Trial ID: NCT01744691
Purpose
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
Official Title
An Open-label, Single Arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With 17p Deletion (RESONATE™-17)
Eligibility
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
Intervention(s):
drug: Ibrutinib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061