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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.
University of Arizona Cancer Center - Out Pt.
Tucson, Arizona, United States
Indiana Blood and Marrow Transplantation
Number of treatment-emergent adverse events (TEAEs)
A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Time frame: Up to approximately 12 months.
Apparent clearance of parsaclisibin combination with rituximab, bendamustine and rituximab, or ibrutinib
Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.
Time frame: Up to approximately 1 month.
Apparent volume of distribution of parsaclisib in combination with rituximab, bendamustine and rituximab, or ibrutinib
Measured to assess the plasma pharmacokinetic profile of parsaclisib in combination with rituximab, bendamustine and rituximab, and ibrutinib.
Time frame: Up to approximately 1 month.
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Ibrutinib administered orally once daily.
Indianapolis, Indiana, United States
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States
Texas Oncology
Austin, Texas, United States
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Smith Clinic
Houston, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
Texas Oncology San Antonio
San Antonio, Texas, United States
Asst Spedali Civili Di Brescia
Brescia, Italy
...and 11 more locations