An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Histologically confirmed diffuse large B-cell lymphoma (DLBCL);
Have received only two prior standard therapy lines for diffuse large B-cell lymphoma (DLBCL) including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy;
Confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy;
Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion;
Have primary central nervous system (CNS) lymphoma or secondary central nervous system (CNS) infiltration, transformed lymphoma, unclassified B-cell lymphoma with features intermediate between DLBCL and classical Hodgkin's lymphoma (HL), primary effusion lymphoma, plasma lymphoma;
Toxicity not yet recovered from previous anti-tumor therapies;
Uncontrolled systemic infections or infections requiring intravenous antibiotics;
Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol;
Single group
abexinostat
Drugabexinostat tablet
Clinical effect by evaluating the objective response rate (ORR)
To evaluate the objective response rate (ORR) of abexinostat in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) as assessed by an independent central imaging review.
Objective Response
Objective response rate (ORR) as assessed by the investigator
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.
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