This is the study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy
This is a global, multicenter open-label, single-arm, Phase 2 study of the PI3Kδ inhibitor Zandelisib (ME-401) in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma after failure of at least 2 prior lines of systemic therapy which must have included an anti-CD20 antibody and chemotherapy with an alkylating agent or a purine analogue. Approximately 180 subjects will be enrolled and treated with Zandelisib (ME-401) on the intermittent schedule.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
169
Zandelisib (ME-401) 60 mg
Objective Response Rate (ORR) of ME-401 in Relapsed or Refractory FL or MZL
ORR is measured as the proportion of subjects achieving the best response rating of CR or PR prior to first PD
Time frame: 3 years 9 months
Duration of Response (DOR)
Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression
Time frame: 3 years 9 months
Complete Response (CR) Rate
Complete response rate will be measured by the number of subjects that achieve CR
Time frame: 3 years 9 months
Progression-free Survival (PFS)
Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death
Time frame: 3 years 9 months
Overall Survival
Overall survival will be measured as the time from initiation of treatment (Day 1) until death
Time frame: 2 years
Overall Incidence of Treatment Emergent Adverse Events (TEAEs)
The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE.
Time frame: 3 years 9 months
PK of ME-401
The PK of ME-401 will be determined by the peak plasma concentration (Cmax)
Time frame: 3 years 9 months
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