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

April 9, 2025 updated by: Xynomic Pharmaceuticals, Inc.

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)

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
      • Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Dalian, China, 116011
        • Recruiting
        • The First Affiliate Hospital of Dalian Medical University
        • Contact:
      • Fuzhou, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Fuzhou, China, 350014
        • Recruiting
        • Fujian Provincial Cancer Hospital
        • Contact:
      • Guangzhou, China, 510030
        • Recruiting
        • Cancer Center of Guangzhou Medical University
        • Contact:
      • Guangzhou, China, 510120
        • Recruiting
        • Sun Yai-sen Memorial Hospital, Sun Yai-sen University
        • Contact:
      • Hangzhou, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
      • Harbin, China, 150081
        • Recruiting
        • The Affiliated Tumor Hospital of Harbin Medical University
        • Contact:
      • Lanzhou, China, 730000
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
      • Linyi, China, 276000
        • Recruiting
        • Linyi Cancer Hospital
        • Contact:
      • Nantong, China, 226361
        • Recruiting
        • Nantong Tumor Hospital
        • Contact:
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Shanghai, China, 200025
        • Recruiting
        • Shanghai Jiao Tong University School Medicine
        • Contact:
      • Shenzhen, China, China
        • Recruiting
        • Second people's Hospital of Shenzhen
        • Contact:
      • Shijiazhuang, China, 050011
        • Recruiting
        • The Forth Hospital of Hebei Medical University
        • Contact:
      • Taiyuan, China, 030001
        • Recruiting
        • First Hospital of Shanxi Medical University
        • Contact:
      • Wuhan, China, 430000
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Xuzhou, China, 221006
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
      • Zhengzhou, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
      • Zhengzhou, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Histologically confirmed diffuse large B-cell lymphoma (DLBCL);
  2. 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;
  3. Confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy;
  4. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion;
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
  6. Meet various hematological, liver and renal function lab parameters.

Exclusion Criteria:

  1. 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;
  2. Toxicity not yet recovered from previous anti-tumor therapies;
  3. Uncontrolled systemic infections or infections requiring intravenous antibiotics;
  4. Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol;
  5. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug;
  6. Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol;
  7. Presence of active graft-versus-host reaction;
  8. Have undergone a major surgery within the last month;
  9. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection;
  10. Have any cardiac impairment as defined per protocol;
  11. Have prior history of malignancies other than diffuse large B-cell lymphoma (DLBCL).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical effect by evaluating the objective response rate (ORR)
Time Frame: up to 56 days
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
Time Frame: up to 56 days
Objective response rate (ORR) as assessed by the investigator
up to 56 days
Progression-free survival
Time Frame: Up to 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Xynomic Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Yuankai SHI, Prof, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2020

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

May 1, 2019

First Posted (Actual)

May 3, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYN-606

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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