NCT03424122

INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

A Phase 1, Open-Label, Dose-Finding Study of INCB050465 in Combination With Investigator Choice of Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of parsaclisib when combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with relapsed or refractory B-cell lymphoma.

Conditions

• B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Parsaclisib	Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
DRUG	Rituximab	Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
DRUG	Bendamustine	Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.
DRUG	Ibrutinib	Ibrutinib administered orally once daily.

Timeline

• Start date: 2018-07-02
• Primary completion: 2022-06-27
• Completion: 2022-06-27
• First posted: 2018-02-06
• Last updated: 2025-08-21

Locations

21 sites across 3 countries: United States, Italy, Spain

Regulatory

• FDA-regulated drug study