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

Primary Purpose

Diffuse Large B-cell Lymphoma (DLBCL)

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
abexinostat
Sponsored by
Xynomic Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma (DLBCL)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Cancer Hospital Chinese Academy of Medical SciencesRecruiting
  • China-Japan Friendship HospitalRecruiting
  • Peking University Third HospitalRecruiting
  • West China Hospital, Sichuan UniversityRecruiting
  • The First Affiliate Hospital of Dalian Medical UniversityRecruiting
  • Fujian Medical University Union HospitalRecruiting
  • Fujian Provincial Cancer HospitalRecruiting
  • Cancer Center of Guangzhou Medical UniversityRecruiting
  • Sun Yai-Sen Memorial Hospital, Sun Yai-Sen UniversityRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • The Affiliated Tumor Hospital of Harbin Medical UniversityRecruiting
  • The First Hospital of Lanzhou UniversityRecruiting
  • Linyi Cancer HospitalRecruiting
  • Nantong Tumor HospitalRecruiting
  • Shanghai Jiao Tong University School MedicineRecruiting
  • Fudan University Shanghai Cancer CenterRecruiting
  • Second People's Hospital of ShenzhenRecruiting
  • The Forth Hospital of Hebei Medical UniversityRecruiting
  • First Hospital of Shanxi Medical UniversityRecruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
  • Henan Cancer HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abexinostat 80 mg bis in die (BID)

Arm Description

Abexinostat 80 mg BID

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Objective Response
Objective response rate (ORR) as assessed by the investigator
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.

Full Information

First Posted
April 30, 2019
Last Updated
July 11, 2023
Sponsor
Xynomic Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03936153
Brief Title
Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xynomic Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma (DLBCL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
A single arm treatment group
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abexinostat 80 mg bis in die (BID)
Arm Type
Experimental
Arm Description
Abexinostat 80 mg BID
Intervention Type
Drug
Intervention Name(s)
abexinostat
Intervention Description
abexinostat tablet
Primary Outcome Measure Information:
Title
Clinical effect by evaluating the objective response rate (ORR)
Description
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.
Time Frame
up to 56 days
Secondary Outcome Measure Information:
Title
Objective Response
Description
Objective response rate (ORR) as assessed by the investigator
Time Frame
up to 56 days
Title
Progression-free survival
Description
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.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Zhao, MD
Phone
(01186)13716386801
Email
bing.zhao@xynomicpharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sophia Paspal, PhD RAC
Phone
610-405-5974
Email
sophia.paspal@xynomicpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai SHI, Prof
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, MD, PhD
Phone
13701251865
Email
syuankaipumc@126.com
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenling Li, M.M.
Phone
13520114408
Email
zryyxy2013@163.com
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyan Ke, MD
Phone
13911068649
Email
xiaoyank@yahoo.com
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqun Zou, MD
Phone
18980601027
Email
zliqun@hotmail.com
Facility Name
The First Affiliate Hospital of Dalian Medical University
City
Dalian
ZIP/Postal Code
116011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yajie Gao, M.M.
Phone
15541192088
Email
gaoyajie100@126.com
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tingbo Liu, PhD
Phone
13365910316
Email
13769988835@139.com
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Wu, M.M.
Phone
13509320201
Email
kkwff123@163.com
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuan Jin, M.M.
Phone
13688896983
Email
jinchuan5959@163.com
Facility Name
Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yudan Wu, M.M.
Phone
13719472080
Email
danwuxu@126.com
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Yang, MD
Phone
13857182590
Email
haiyanyang1125@163.com
Facility Name
The Affiliated Tumor Hospital of Harbin Medical University
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang, MD
Phone
13313612989
Email
sy86298276@163.com
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
ZIP/Postal Code
730000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaming Xi, MD
Phone
13919110815
Email
xiyaming02@163.com
Facility Name
Linyi Cancer Hospital
City
Linyi
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Wang, M.M.
Phone
15168920632
Email
LYSZLYYNSK@163.com
Facility Name
Nantong Tumor Hospital
City
Nantong
ZIP/Postal Code
226361
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohong Xu, MD
Phone
18912296003
Email
xhx107@163.com
Facility Name
Shanghai Jiao Tong University School Medicine
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunkang Chang, MD
Phone
13764643870
Email
Changchunkang7010@126.com
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junning Cao, M.M.
Phone
13817384270
Email
cao_junning@126.com
Facility Name
Second People's Hospital of Shenzhen
City
Shenzhen
ZIP/Postal Code
China
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Du, MD
Phone
13602523722
Email
duxingz@medmail.com.cn
Facility Name
The Forth Hospital of Hebei Medical University
City
Shijiazhuang
ZIP/Postal Code
050011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhuan Gao, MD
Phone
13503217908
Email
ydsygao@sina.com
Facility Name
First Hospital of Shanxi Medical University
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weihua Zhang, MD
Phone
13015474570
Email
zwhlzh@126.com
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liling Zhang, MD
Phone
15871725926
Email
lily1228@sina.com
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
ZIP/Postal Code
221006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenyu Li, MD
Phone
13852439312
Email
frankfeng_2004@126.com
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yufu Li, MD
Phone
13598009218
Email
liyufu439@163.com
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingzhi Zhang, MD
Phone
13838565629
Email
mingzhi_zhang@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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