An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of oral histone deacetylase (HDAC)-inhibitor abexinostat, as monotherapy in patients with relapsed or refractory follicular lymphoma (FL)
This is an open-label, single-arm, two-stage, multi-center, phase 2 study in patients with relapsed/refractory follicular lymphoma (FL) who have received at least two prior standard therapy lines.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Abexinostat tablets
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review
Objective response rate (ORR), defined as the proportion of patients who have completed response (CR) or partial response (PR) as assessed by an Independent Central Imaging Review
Time frame: up to 56 days
Objective Response
Objective response rate (ORR) as assessed by the investigator
Time frame: up to 56 days
Progression-free survival
Progression-free survival (PFS), defined as the time from the initiation of treatment to disease progression or death as assessed by the Independent Central Imaging Review and the investigator
Time frame: Up to 2 years
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China-Japan Friendship Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Jilin Cancer Hospital
Changchun, China
West China Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
Fujian Medical University Union Hospital
Fuzhou, China
Cancer Center of Guangzhou Medical University
Guangzhou, China
Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
Guangzhou, China
Nanfang Hospital
Guangzhou, China
...and 16 more locations