The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Parsaclisib once daily for 8 weeks followed by once weekly
Objective Response Rate Based on Lugano Classification Criteria in Group A
Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.
Time frame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Duration of Response in Group A
Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response as determined by IRC.
Time frame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Progression-free Survival in Group A
Defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment as provided by an IRC.
Time frame: Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months
Overall Survival (OS) in Group A
Defined as the time from the date of the first dose of study drug until death by any cause.
Time frame: From first dose of study drug until death by any cause; up to 26 months
Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of parsaclisib until 30 days after the last dose administration.
Time frame: Screening through 35 days after end of treatment, up to 42 months
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Arizona Oncology Associates, PC - HAL
Tempe, Arizona, United States
Sutter Gould Medical Foundation
Modesto, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Advanced Pharma CR, LLC
Miami, Florida, United States
Asclepes Research Centers
Weeki Wachee, Florida, United States
Advocate Medical Group Niles Milwaukee Ave
Niles, Illinois, United States
Indiana BMT
Beech Grove, Indiana, United States
Parkview Research Center
Fort Wayne, Indiana, United States
...and 60 more locations