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

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)

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Lymphoma, Follicular
• Intervention / Treatment: Drug: Abexinostat

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing, China, 100029
    • China-Japan Friendship Hospital
  • Beijing, China, 100021
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Changchun, China, 130012
    • Jilin Cancer Hospital
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Dalian, China, 116011
    • The First Affiliated Hospital of Dalian Medical University
  • Fuzhou, China, 350001
    • Fujian Medical University Union Hospital
  • Guangzhou, China, 510515
    • Nanfang Hospital
  • Guangzhou, China, 510030
    • Cancer Center of Guangzhou Medical University
  • Guangzhou, China, 510120
    • Sun Yai-sen Memorial Hospital, Sun Yai-sen University
  • Hainan, China, 570311
    • Hainan General Hospital
  • Hangzhou, China, 310022
    • Zhejiang Cancer Hospital
  • Hangzhou, China, 310009
    • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Hangzhou, China, 310020
    • Sir Run Run Shaw Hospital, Zhejiang University School of Medical
  • Harbin, China, 150081
    • The Affiliated Tumor Hospital of Harbin Medical University
  • Lanzhou, China, 730000
    • The First Hospital of Lanzhou University
  • Linyi, China, 276000
    • Linyi Cancer Hospital
  • Nantong, China, 226361
    • Nantong Tumor Hospital
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Shanghai, China, 200025
    • Shanghai sixth people's hospital
  • Shijiazhuang, China, 050011
    • The Forth Hospital of Hebei Medical University
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Tianjin, China, 300000
    • Tianjin People's Hospital
  • Xuzhou, China, 221006
    • The Affiliated Hospital of Xuzhou Medical University
  • Zhengzhou, China, 450008
    • Henan Cancer Hospital
  • Zhengzhou, China, 450052
    • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Life expectancy ≥ 3 months
2. Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL)
3. 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)
4. 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
5. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI);
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
7. Meet various hematological, liver function and renal function lab parameters

Exclusion Criteria:

1. Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL)
2. Current or history of central nervous system (CNS) lymphoma;
3. Toxicity not yet recovered from previous anti-tumor therapies
4. Uncontrolled systemic infections or infections requiring intravenous antibiotics
5. Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors;
6. Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days
7. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug
8. 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
9. Presence of active graft-versus-host disease
10. Have undergone a major surgery within 28 days
11. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection
12. Have cardiac impairment as defined per protocol
13. Have prior history of malignancies other than follicular lymphoma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abexinostat 80 mg bis in die (BID); Experimental: Abexinostat 80 mg BID	Drug: Abexinostat; Abexinostat tablets

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xynomic Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Yuankai SHI, Prof, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2020
• Primary Completion (Actual): January 29, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: April 29, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: relapsed; refractory; lymph nodes
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Follicular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Histone Deacetylase Inhibitors; Abexinostat
• Other Study ID Numbers: XYN-605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No