Study Evaluating Safety and Efficacy of INCB050465 Combined With Bendamustine and Obinutuzumab in Relapsed or Refractory Follicular Lymphoma (CITADEL-102)
NCT03039114 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2025-08-21
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
Interventions
- 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
-
Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Fitzroy Dawkins, MD · Incyte Corporation
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-15
- Primary Completion
- 2021-03-30
- Completion
- 2021-03-30
- FDA Drug
- Yes
Countries
- United States
- Czechia
- Denmark
- Hungary
- Italy
- Spain
Study Locations
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