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 — DRUG
    Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
  • Rituximab — DRUG
    Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
  • Bendamustine — DRUG
    Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.
  • Ibrutinib — DRUG
    Ibrutinib 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 A
    Parsaclisib + Rituximab
  • Experimental: Treatment B
    Parsaclisib + Bendamustine + Rituximab
  • Experimental: Treatment C
    Parsaclisib + Ibrutinib

Primary Outcome Measure

Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 12 months. ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer Center - Out Pt.TucsonArizona85719-
Indiana Blood and Marrow TransplantationIndianapolisIndiana46237-
Comprehensive Cancer Center of NevadaLas VegasNevada89169-
Texas OncologyAustinTexas78705-
Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
Baylor College of MedicineHoustonTexas77030-
Smith ClinicHoustonTexas77054-
Cancer Care Centers of South TexasSan AntonioTexas78217-
Texas Oncology San AntonioSan AntonioTexas78240-

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