A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

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 oral histone deacetylase (HDAC)-inhibitor abexinostat, as monotherapy in patients with relapsed or refractory follicular lymphoma (FL)

Detailed Description
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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.

Official Title
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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 Follicular Lymphoma (FL)

Conditions
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Lymphoma, Follicular

Intervention / Treatment
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* Drug: Abexinostat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Life expectancy ≥ 3 months Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL) Have received at least two prior standard therapy lines including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy for follicular lymphoma (FL) Confirmed to be unresponsive to the last line of therapy (have stable disease or disease progression during treatment),or have disease progression following the last line of therapy Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI); Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Meet various hematological, liver function and renal function lab parameters Exclusion Criteria: Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL) Current or history of central nervous system (CNS) lymphoma; Toxicity not yet recovered from previous anti-tumor therapies Uncontrolled systemic infections or infections requiring intravenous antibiotics Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors; Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug Have received autologous stem cell transplant within 3 months before the first dose, or allogeneic stem cell transplant within 6 months before the first dose Presence of active graft-versus-host disease Have undergone a major surgery within 28 days Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection Have cardiac impairment as defined per protocol Have prior history of malignancies other than follicular lymphoma

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory, relapsed, lymph nodes