Clinical Trial

PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia

Active, Not Recruiting Phase 2
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Summary
This is a Phase II, single institution open-label, non-randomized monotherapy study to evaluate the clinical efficacy and durable disease control of PCI-32765 administered to patients with relapsed/refractory CLL/SLL/PLL of all risk categories with patients having deletion 17p13 independently evaluated.
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2012-04-27; most recent amendment 2026-04-01.
Status change: Recruiting → Active, Not Recruiting 2014-08-19
Status change: Not Yet Recruiting → Recruiting 2012-06-07
Trial Details
NCT Number NCT01589302
Lead Sponsor Kami Maddocks, MD
Conditions Prolymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory/Relapsed Chronic Lymphocytic Leukemia
Enrollment 154 participants
Start Date 2012-05-21
Primary Completion 2016-07-28 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-13