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

January 22, 2024 updated by: Xynomic Pharmaceuticals, Inc.

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

96

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:
      • Changchun, China, 130012
        • Recruiting
        • Jilin Cancer Hospital
        • Contact:
      • Chengdu, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
      • Dalian, China, 116011
        • Recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
      • Fuzhou, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Guangzhou, China, 510515
        • Recruiting
        • Nanfang 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:
      • Hainan, China, 570311
        • Recruiting
        • Hainan General Hospital
        • Contact:
      • Hangzhou, China, 310022
        • Recruiting
        • Zhejiang Cancer hospital
        • Contact:
      • Hangzhou, China, 310009
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, China, 310020
        • Recruiting
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medical
        • 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 Sixth People's Hospital
        • Contact:
      • Shijiazhuang, China, 050011
        • Recruiting
        • The Forth Hospital of Hebei Medical University
        • Contact:
      • Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Tianjin, China, 300000
        • Recruiting
        • Tianjin People's Hospital
        • 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. 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

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)
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
Time Frame: up to 56 days
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
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)

April 22, 2020

Primary Completion (Estimated)

February 29, 2024

Study Completion (Estimated)

September 30, 2024

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 (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

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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