Back to resultsA Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
Primary Purpose
Lymphoma, Follicular
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Abexinostat
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Follicular focused on measuring refractory, relapsed, lymph nodes
Eligibility Criteria
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
Sites / Locations
- Cancer Hospital Chinese Academy of Medical SciencesRecruiting
- China-Japan Friendship HospitalRecruiting
- Peking University Third HospitalRecruiting
- Jilin Cancer HospitalRecruiting
- West China Hospital, Sichuan UniversityRecruiting
- The First Affiliated Hospital of Dalian Medical UniversityRecruiting
- Fujian Medical University Union HospitalRecruiting
- Cancer Center of Guangzhou Medical UniversityRecruiting
- Sun Yai-Sen Memorial Hospital, Sun Yai-Sen UniversityRecruiting
- Nanfang HospitalRecruiting
- Hainan General HospitalRecruiting
- The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
- Sir Run Run Shaw Hospital, Zhejiang University School of MedicalRecruiting
- Zhejiang Cancer HospitalRecruiting
- The Affiliated Tumor Hospital of Harbin Medical UniversityRecruiting
- The First Hospital of Lanzhou UniversityRecruiting
- Linyi Cancer HospitalRecruiting
- Nantong Tumor HospitalRecruiting
- Shanghai Sixth people's hospitalRecruiting
- Fudan University Shanghai Cancer CenterRecruiting
- The Forth Hospital of Hebei Medical UniversityRecruiting
- Tianjin People's HospitalRecruiting
- Tianjin Medical University General HospitalRecruiting
- 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
Experimental: Abexinostat 80 mg BID
Outcomes
Primary Outcome Measures
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
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
NCT ID
NCT03934567
First Posted
April 29, 2019
Last Updated
March 15, 2023
Sponsor
Xynomic Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03934567
Brief Title
A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (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
Product Manufactured in and Exported from the U.S.
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 oral histone deacetylase (HDAC)-inhibitor abexinostat, as monotherapy in patients with relapsed or refractory follicular lymphoma (FL)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Follicular
Keywords
refractory, relapsed, lymph nodes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Abexinostat 80 mg bis in die (BID)
Arm Type
Experimental
Arm Description
Experimental: Abexinostat 80 mg BID
Intervention Type
Drug
Intervention Name(s)
Abexinostat
Intervention Description
Abexinostat tablets
Primary Outcome Measure Information:
Title
Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review
Description
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
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:
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
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, Ph.D. 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
Jilin Cancer Hospital
City
Changchun
ZIP/Postal Code
130012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng, M.M.
Phone
13943012851
Email
jl.cheng@163.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 Affiliated 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
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
13857182590
Email
haiyanyang1125@163.com
Facility Name
Nanfang Hospital
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ru Feng, M.M.
Phone
13725119672
Email
Ruth1626@126.com
Facility Name
Hainan General Hospital
City
Hainan
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongxia Yao, M.M.
Phone
13876081106
Email
yaohongxia768@163.com
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbin Qian
Phone
13605801032
Email
Qianwenb@aliyun.com
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medical
City
Hangzhou
ZIP/Postal Code
310020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongming Pan, MD
Phone
0571-86006926
Email
shonco@sina.cn
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 Sixth people's hospital
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
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
Tianjin People's Hospital
City
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinghua Wang, PhD
Phone
18622221223
Email
huaqingw@163.com
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Fu
Phone
13920350233
Email
florai@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
A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
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