NCT03039114

Study Evaluating Safety and Efficacy of INCB050465 Combined With Bendamustine and Obinutuzumab in Relapsed or Refractory Follicular Lymphoma (CITADEL-102)

An Open-Label, Dose-Finding, and Cohort-Expansion Phase 1 Study Evaluating Safety and Efficacy of INCB050465 in Combination With Bendamustine and Obinutuzumab in Subjects With Relapsed or Refractory Follicular Lymphoma (CITADEL-102)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (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 efficacy of parsaclisib when combined with bendamustine and obinutuzumab in subjects with relapsed or refractory follicular lymphoma (FL).

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Parsaclisib	Parsaclisib at the protocol-defined starting dose administered once daily for 8 weeks followed by once weekly.
DRUG	Hexal	Bendamustine 90 mg/m\^2 administered intravenously at protocol-defined timepoints.
DRUG	Gazyvaro	Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.

Timeline

• Start date: 2017-02-15
• Primary completion: 2021-03-30
• Completion: 2021-03-30
• First posted: 2017-02-01
• Last updated: 2025-08-21

Locations

21 sites across 6 countries: United States, Czechia, Denmark, Hungary, Italy, Spain

Regulatory

• FDA-regulated drug study