INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Incyte Corporation
- Study ID
- NCT03424122
- Phase
- PHASE1
- Status
- Completed
Conditions
- B-cell Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Parsaclisib — DRUGParsaclisib administered orally once daily for 8 weeks followed by once weekly.
- Rituximab — DRUGRituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
- Bendamustine — DRUGBendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.
- Ibrutinib — DRUGIbrutinib administered orally once daily.
Study Details
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.
Key Dates
- Start date
- Jul 2, 2018
- Status verified
- Aug 2025
- Primary completion
- Jun 27, 2022
- Completion
- Jun 27, 2022
Study Design
- Enrollment
- 50 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment AParsaclisib + Rituximab
- Experimental: Treatment BParsaclisib + Bendamustine + Rituximab
- Experimental: Treatment CParsaclisib + Ibrutinib
Primary Outcome Measure
Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 12 months. ]
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Arizona Cancer Center - Out Pt. | Tucson | Arizona | 85719 | - |
| Indiana Blood and Marrow Transplantation | Indianapolis | Indiana | 46237 | - |
| Comprehensive Cancer Center of Nevada | Las Vegas | Nevada | 89169 | - |
| Texas Oncology | Austin | Texas | 78705 | - |
| Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | - |
| Baylor College of Medicine | Houston | Texas | 77030 | - |
| Smith Clinic | Houston | Texas | 77054 | - |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78217 | - |
| Texas Oncology San Antonio | San Antonio | Texas | 78240 | - |
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