At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 199 enrolled
Drug / intervention
PCI-32765drug
Likely dose
Not stated in 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 Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
In Brief
A Phase 2 clinical trial evaluating PCI-32765 for B-cell Chronic Lymphocytic Leukemia and 9 related conditions. Completed, enrolled 199 participants across 16 sites.
Detailed Summary
The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-cell Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Diffuse Well-differentiated Lymphocytic Lymphoma, B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma, Waldenstrom Macroglobulinemia, Burkitt Lymphoma, B-Cell Diffuse Lymphoma
CountriesUnited States
CollaboratorsJanssen Research & Development, LLC
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartJun 2010
Primary CompletionApr 2019
TodayJul 2026
First PostedApr 22, 2010
Enrollment StartJun 1, 2010
Primary CompletionApr 26, 2019
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 16.2 years ago
Interventions
PCI-32765drug
Dose based on parent protocol