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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Parsaclisib at the protocol-defined starting dose administered once daily for 8 weeks followed by once weekly.
Bendamustine 90 mg/m\^2 administered intravenously at protocol-defined timepoints.
Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.
Banner Health
Gilbert, Arizona, United States
University of California, San Diego
Safety and tolerability of parsaclisib in combination with bendamustine and obinutuzumab in relapsed or refractory FL, assessed by number of subjects with adverse events (AEs)
Time frame: Screening through 30-35 days after end of treatment, up to approximately 34 months per subject
Objective response rate based on Lugano classification criteria
Defined as percentage of subjects with a complete response (CR) and partial response (PR), as determined by investigator assessment of response
Time frame: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Complete response rate based on Lugano classification criteria
Defined as percentage of subjects who achieve a best overall response of CR
Time frame: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Duration of response
Defined as time from first documented evidence of CR or PR until earliest date of disease progression or death due to any cause.
Time frame: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Progression-free survival
Defined as time from the date of the first dose of study drug until the earliest date of disease progression (determined by radiographic disease assessment/Lugano classification criteria) or death due to any cause.
Time frame: Protocol-defined timepoints throughout the treatment period, up to approximately 34 months per subject
Overall survival
Defined as the time from the date of the first dose of study drug until death due to any cause.
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La Jolla, California, United States
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Fairway, Kansas, United States
Center for Cancer and Blood Disorders (CCBD) - Bethesda
Bethesda, Maryland, United States
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Lake Success, New York, United States
Froedtert & Medical College of Wisconsin & Affiliated Hospitals
Milwaukee, Wisconsin, United States
FN Ostrava / Ostrava
Ostrava, Czechia
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
The Finsen Centre, National Hospital
Copenhagen, Denmark
...and 11 more locations
Time frame: From the date of the first dose of study drug until death due to any cause, assessed up to approximately 34 months per subject