At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 33 enrolled
Drug / intervention
PCI-32765drug
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.
A Phase 1b, Multicenter, Open-label, Parallel-group Safety Study of a Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI 32765, in Combination With Chemotherapy in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
In Brief
A Phase 1 clinical trial evaluating PCI-32765 for B-cell Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Completed, enrolled 33 participants across 6 sites.
Detailed Summary
The purpose of this study is to establish the safety of orally administered PCI-32765 in combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2011
First PostedFeb 2011
Primary CompletionNov 2012
Study CompletionMay 2013
TodayJul 2026
First PostedFeb 9, 2011
Enrollment StartFeb 1, 2011
Primary CompletionNov 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.4 years ago
Interventions
PCI-32765drug
420 mg daily