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

Trial ID or NCT#

NCT01744691

Status

not recruiting iconNOT RECRUITING

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 Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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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Contact

Cancer Clinical Trials Office
650-498-7061