At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 99 enrolled
Drug / intervention
IPI-145 +1 moredrug
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 Study of IPI-145 and Ofatumumab in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI-145-07 Duvelisib (IPI-145)
In Brief
A Phase 3 clinical trial evaluating IPI-145 and Ofatumumab for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Completed, enrolled 99 participants across 69 sites in 11 countries.
Detailed Summary
A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 (duvelisib) monotherapy or ofatumumab monotherapy in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who experienced disease progression after treatment with IPI-145 or ofatumumab in study IPI-145-07 (NCT02004522).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, France, Germany, Hungary, Italy, New Zealand, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedJan 2014
Primary CompletionJun 2020
TodayJul 2026
First PostedJan 30, 2014
Enrollment StartDec 1, 2013
Primary CompletionJun 12, 2020
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 12.4 years ago
Interventions
IPI-145drug
PI3K Inhibitor
Ofatumumabdrug
Monoclonal antibody