This is a study designed to evaluate the efficacy and safety of oral YY-20394 in patients with R/R follicular non-Hodgkin's lymphoma who have failed at least two prior systemic therapies.
The study will be conducted in China to provide safety and efficacy data from this region. A Safety Run-in will be conducted to confirm the safety of the recommended Phase 2 dose (RP2D), 80 mg once daily, in a Asian population. PK samplings at Cycle 1, Day 1 will be taken.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
123
YY-20394 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITINGOverall response rate, ORR
Overall response rate (ORRProportion of patients whose tumor volume reduces to a predetermined value and can maintain the minimum time limit-) assessed by an Independent Review Committee (IRC).
Time frame: Throughout the study for approximately 2 years
Overall response rate (ORR)
Overall response rate (ORR-Proportion of patients whose tumor volume reduces to a predetermined value and can maintain the minimum time limit) assessed by reseachers.
Time frame: Throughout the study for approximately 2 years
Progression free survival, PFS
PFS, defined as the time from the first dose of study treatment to first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Throughout the study for approximately 2 years
Overall survival, OS
The time from randomization to death for any reason.
Time frame: Throughout the study for approximately 2 years
Disease control rate, DCR
The percentage of cases with remission (PR+CR)and stable lesions(SD) after treatment in the number of evaluable cases.
Time frame: Throughout the study for approximately 2 years
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