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

Study Overview
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Brief Summary
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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)

Detailed Description
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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)

Official Title
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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)

Conditions
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Diffuse Large B-cell Lymphoma (DLBCL)

Intervention / Treatment
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* Drug: abexinostat


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A single arm treatment group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abexinostat 80 mg bis in die (BID)<br>Abexinostat 80 mg BID | Drug: abexinostat<br>* abexinostat tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response | Objective response rate (ORR) as assessed by the investigator | 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. | Up to 2 years |