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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmacyclics LLC.
• Collaborator: Janssen Research & Development, LLC

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