This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus BR versus placebo plus BR as first-line treatment of participants with newly diagnosed MCL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
parsaclisib will be administered orally once daily.
rituximab is administered IV on Day 1 of each 28-day cycle for 6 cycles.
bendamustine is administered IV on Day 1 and 2 of each 28-day cycle for 6 cycles.
Progression Free Survival
Defined as the time from the date of randomization until the date of first-documented disease progression, as determined by an Independent Review Committee (IRC) based on the Lugano criteria, or death from any cause, whichever happens first.
Time frame: 7 years
Overall Survival
Defined as the time from the date of randomization until death from any cause.
Time frame: 10 years
Objective Response Rate
Defined as the proportion of participants with a Complete Response (CR) or Partial Response (PR) as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas.
Time frame: 7 Years
Complete Response Rate
Defined as the proportion of participants with a CR as determined by an IRC- provided radiographic disease assessment of response according to response criteria for lymphomas.
Time frame: 7 Years
Duration of Response
Defined as the time from first-documented evidence of CR or PR until first documented disease progression or death from any cause, whichever happens first, among participants who achieve an objective response, as determined by radiographic disease assessment provided by an IRC.
Time frame: 7 Years
Duration Of Complete Response
Defined as the time from the first evidence of CR to the date of first documented disease progression or death from any cause, whichever happens first, among participants who achieve a CR, as determined by radiographic disease assessment provided by an IRC.
Time frame: 7 Years
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placebo will be administered orally once daily
Disease Control Rate
Defined as the proportion of participants who achieved a response of CR, PR, or Stable Disease (SD) assessed by an IRC.
Time frame: 7 Years
Event Free Survival
Defined as the time from date of randomization to date of first documented progression, as determined by radiographic disease assessment provided by an IRC, administration of a new anti lymphoma treatment, or death from any cause, whichever happens first.
Time frame: 7 Years
Time To Next anti-Lymphoma Treatment
Defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment.
Time frame: 7 Years
Progression-Free Survival on next anti-lymphoma treatment
Defined as the time from the date of randomization to the date of first documented disease progression as reported by investigator after next anti-lymphoma treatment or death from any cause, or start of a third anti-lymphoma treatment since randomization, whichever happens first.
Time frame: 7 Years
Treatment Emergent Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug/treatment.
Time frame: 7 Years