At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 71 enrolled
Drug / intervention
PCI-32765 +1 moredrug
Likely dose
PCI-32765 420 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Phase 1b/2, Safety and Efficacy Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, and Ofatumumab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Prolymphocytic Leukemia
In Brief
A Phase 2 clinical trial evaluating PCI-32765 and ofatumumab for B-cell Chronic Lymphocytic Leukemia and 3 related conditions. Completed, enrolled 71 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocyctic Leukemia, Richter's Transformation
CountriesUnited States
CollaboratorsOhio State University
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartDec 2010
Primary CompletionJun 2013
Study CompletionMay 2014
TodayJul 2026
First PostedOct 8, 2010
Enrollment StartDec 1, 2010
Primary CompletionJun 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.7 years ago
Interventions
PCI-32765drug
420 mg PO daily
ofatumumabdrug
per package insert as an IV infusion