CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
Parsaclisibdrug
Likely dose
Parsaclisib at the protocol-defined doseAI-extracted
Key inclusion· 5
  • ✓Histologically confirmed marginal zone lymphoma (extranodal, nodal, or splenic subtypes)
  • ✓Radiographically measurable lymphadenopathy or extranodal disease (≥1 lesion >1.5 cm longest transverse diameter and ≥1.0 cm longest perpendicular diameter), or bone marrow infiltration of MZL if splenic MZL without measurable disease
  • ✓Age ≥18 years (≥19 in South Korea)
  • ✓ECOG performance status 0-2
Key exclusion· 5
  • ✕Evidence of diffuse large B-cell transformation
  • ✕History of CNS lymphoma (primary or metastatic) or leptomeningeal disease
  • ✕Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or pan-PI3K inhibitors
  • ✕Allogeneic stem cell transplant within 6 months or autologous stem cell transplant within 3 months of first dose

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03144674
NCT03144674Phase 2Completed
CompareCT.gov

A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)

Incyte Corporation·interventional·Posted May 9, 2017·Updated Jul 11, 2025

In Brief

A Phase 2 clinical trial evaluating Parsaclisib for Lymphoma. Completed, enrolled 110 participants across 86 sites in 12 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesArgentina, Australia, Belgium, Denmark, France, Germany, Israel, Italy, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 9, 2017
Enrollment StartDec 18, 2017
Primary CompletionJan 15, 2021
Study CompletionMay 29, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.1 years ago

Interventions

Parsaclisibdrug

Parsaclisib at the protocol-defined dose.