At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 162 enrolled
Drug / intervention
Parsaclisibdrug
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 Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)
In Brief
A Phase 2 clinical trial evaluating Parsaclisib for Lymphoma. Completed, enrolled 162 participants across 103 sites in 11 countries.
Detailed Summary
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesBelgium, Czechia, Denmark, France, Germany, Israel, Italy, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartNov 2017
Primary CompletionApr 2024
TodayJul 2026
First PostedAug 1, 2017
Enrollment StartNov 20, 2017
Primary CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 8.9 years ago
Interventions
Parsaclisibdrug
Parsaclisib tablets administered orally with water and without regard to food.