A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma
Patients will be recruited for 2 cohorts. Cohort A will recruit 58 RRFL subjects, and Cohort B will recruit 62 RRMZL subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
IBI376 20 mg po. once daily for 8 weeks ,followed by 2.5mg once daily
Ruijin hospital, school of medicine, Shanghai jiao tong university
Shanghai, China
Objective Response Rate (ORR)
To assess the efficacy of IBI376 in terms of objective response rate (ORR) in subjects with relapsed or refractory follicular lymphoma (FL)/Marginal lymphoma(MZL). Subjects will be evaluated for ORR by an IRC (Lugano criteria)
Time frame: 2 years
Complete Response Rate (CRR)
To assess complete response rate (CRR)
Time frame: 2 years
Duration of Response (DOR)
To assess the duration of response (DOR)
Time frame: 2 years
Progression-free Survival (PFS)
To assess progression-free survival (PFS)
Time frame: 2 years
Overall Survival (OS)
To assess overall survival (OS)
Time frame: 2 years
Best percentage change in target lesion size
To assess best percentage change in target lesion size
Time frame: 2 years
Safety and tolerability of IBI376 measured by adverse events (AEs)
Defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
Time frame: Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject
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