Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

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 diffuse large B-cell lymphoma (DLBCL)

Inclusion criteria

• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
• Meet various hematological, liver and renal function lab parameters.

Exclusion criteria

• 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;
• Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug;
• Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol;
• Presence of active graft-versus-host reaction;
• Have undergone a major surgery within the last month;
• Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection;
• Have any cardiac impairment as defined per protocol;
• Have prior history of malignancies other than diffuse large B-cell lymphoma (DLBCL).