This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus investigator's choice of either rituximab or obinutuzumab versus placebo plus investigator's choice of rituximab or obinutuzumab for the treatment of participants with R/R FL or MZL. The Participants will be stratified in a 1:1 randomization ratio by investigator's choice of rituximab or obinutuzumab prior to randomization, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (MZL or FL) .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
parsaclisib will be administered once daily at 20 mg for 8 weeks followed by 2.5 mg once daily.
rituximab will be administered intravenously on select days as per protocol.
obinutuzumab will be administered intravenously on select days as per protocol.
Progression Free Survival (PFS) in R/R FL and MZL participants
Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.
Time frame: 62 months
Progression Free Survival (PFS) in R/R FL participants
Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.
Time frame: 62 months
Overall Response Rate (ORR)
Defined as the proportion of participants with a CR or PR as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014).
Time frame: 62 months
Overall Survival (OS)
Defined as the time from the date of randomization until death from any cause.
Time frame: 10 years
Progression Free Survival (PFS) in R/R MZL participants
Defined as the time from the date of randomization until the first documented disease progression as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014) or death from any cause, whichever occurs first.
Time frame: 62 months
Complete Response Rate (CRR)
Defined as the proportion of participants with a CR as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014).
Time frame: 62 months
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Duration of Response (DOR)
Defined as the time from the date of first documented evidence of CR or PR until the first documented disease progression or death from any cause, whichever occurs first, among participants who achieve an objective response as determined by IRC based on the Lugano criteria for response assessment (Cheson et al 2014).
Time frame: 62 months
Disease Control Rate (DCR)
Defined as the proportion of participants who achieve best overall response of CR, PR, or SD (Cheson et al 2014) as determined by IRC.
Time frame: 62 months
Event Free Survival (EFS)
Defined as the time from the date of randomization to the first documented disease progression as determined by radiographic disease assessment provided by IRC, the initiation of a new antilymphoma therapy, or death from any cause, whichever occurs first.
Time frame: 62 months
Time To Next antiLymphoma Therapy (TTNLT)
Defined as the time from the date of randomization to the first documented administration of a new antilymphoma therapy.
Time frame: 62 months
Progression-Free Survival on next antilymphoma therapy (PFS2)
Defined as the time from the date of randomization to the first documented disease progression as reported by the investigator after the initiation of a new antilymphoma therapy, death from any cause, or start of a third antilymphoma therapy since randomization in the study, whichever occurs first.
Time frame: 62 months
Number of Treatment Emergent Adverse Events (TEAE's)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time frame: 62 months