Diffuse Large B-cell Lymphoma (DLBCL)Phase 2NCT03936153
Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
A Phase 2 study testing abexinostat in people with Diffuse Large B-cell Lymphoma (DLBCL), run by Xynomic Pharmaceuticals, Inc. at 23 sites in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma (DLBCL)
- What is being tested?
- abexinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 23 sitesChina
- Study dates
- 20 Jan 2020to 31 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
China23 sites, 23 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021
Yuankai Shi, MD, PhD, 13701251865, syuankaipumc@126.com
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Zhenling Li, M.M., 13520114408, zryyxy2013@163.com
- Recruiting
Peking University Third Hospital
Beijing, 100191
Xiaoyan Ke, MD, 13911068649, xiaoyank@yahoo.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Liqun Zou, MD, 18980601027, zliqun@hotmail.com
- Recruiting
The First Affiliate Hospital of Dalian Medical University
Dalian, 116011
Yajie Gao, M.M., 15541192088, gaoyajie100@126.com
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, 350001
Tingbo Liu, PhD, 13365910316, 13769988835@139.com
- Recruiting
Fujian Provincial Cancer Hospital
Fuzhou, 350014
Hui Wu, M.M., 13509320201, kkwff123@163.com
- Recruiting
Cancer Center of Guangzhou Medical University
Guangzhou, 510030
Chuan Jin, M.M., 13688896983, jinchuan5959@163.com
- Recruiting
Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
Guangzhou, 510120
Yudan Wu, M.M., 13719472080, danwuxu@126.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, 310022
Haiyan Yang, MD, 13857182590, haiyanyang1125@163.com
- Recruiting
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, 150081
Qingyuan Zhang, MD, 13313612989, sy86298276@163.com
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, 730000
Yaming Xi, MD, 13919110815, xiyaming02@163.com
- Recruiting
Linyi Cancer Hospital
Linyi, 276000
Zhen Wang, M.M., 15168920632, LYSZLYYNSK@163.com
- Recruiting
Nantong Tumor Hospital
Nantong, 226361
Xiaohong Xu, MD, 18912296003, xhx107@163.com
- Recruiting
Shanghai Jiao Tong University School Medicine
Shanghai, 200025
Chunkang Chang, MD, 13764643870, Changchunkang7010@126.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Junning Cao, M.M., 13817384270, cao_junning@126.com
- Recruiting
Second People's Hospital of Shenzhen
Shenzhen, China
Xin Du, MD, 13602523722, duxingz@medmail.com.cn
- Recruiting
The Forth Hospital of Hebei Medical University
Shijiazhuang, 050011
Yuhuan Gao, MD, 13503217908, ydsygao@sina.com
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, 030001
Weihua Zhang, MD, 13015474570, zwhlzh@126.com
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430000
Liling Zhang, MD, 15871725926, lily1228@sina.com
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221006
Zhenyu Li, MD, 13852439312, frankfeng_2004@126.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, 450008
Yufu Li, MD, 13598009218, liyufu439@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052
Mingzhi Zhang, MD, 13838565629, mingzhi_zhang@163.com
About this study
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)
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)
Read the 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)
- Conditions
- Diffuse Large B-cell Lymphoma (DLBCL)
- Being tested
- abexinostat
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abexinostatDrug
abexinostat tablet
| Study group | Role | What they receive |
|---|---|---|
| Abexinostat 80 mg bis in die (BID) | Experimental | Abexinostat 80 mg BID Receives: Drug: abexinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 56 days
Secondary outcomes (2)
Objective Response
Objective response rate (ORR) as assessed by the investigator
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start20 Jan 2020
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell Lymphoma (DLBCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single arm treatment group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xynomic Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai SHI, Prof, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936153
- Sponsor's protocol ID
- XYN-606
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2019
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03936153
- Acronym / sponsor ID
- XYN-606
- Conditions
- Diffuse Large B-cell Lymphoma (DLBCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Xynomic Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single arm treatment group
| Arm | Type | Receives |
|---|---|---|
| Abexinostat 80 mg bis in die (BID) | Experimental | Drug: abexinostatAbexinostat 80 mg BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abexinostatabexinostat tablet | Drug | Abexinostat 80 mg bis in die (BID) |
Primary outcome
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.
2 secondary outcomes
Objective Response
Time frame: up to 56 days
Progression-free survival
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuankai SHI, Prof principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing abexinostat in people with Diffuse Large B-cell Lymphoma (DLBCL), run by Xynomic Pharmaceuticals, Inc. at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bing Zhao, MD ((01186)13716386801, bing.zhao@xynomicpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effect by evaluating the objective response rate (ORR) (time frame: up to 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.