Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
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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)
Condition or disease
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)
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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).