Lymphoma, FollicularPhase 2NCT03934567
A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
A Phase 2 study testing Abexinostat in people with Lymphoma, Follicular, run by Xynomic Pharmaceuticals, Inc. at 26 sites in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Follicular
- 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
- 87 participants
- Where
- 26 sitesChina
- Study dates
- 22 Apr 2020to 30 Oct 2025
- 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
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021
China-Japan Friendship Hospital
Beijing, 100029
Peking University Third Hospital
Beijing, 100191
Jilin Cancer Hospital
Changchun, 130012
West China Hospital, Sichuan University
Chengdu, 610041
The First Affiliated Hospital of Dalian Medical University
Dalian, 116011
Fujian Medical University Union Hospital
Fuzhou, 350001
Cancer Center of Guangzhou Medical University
Guangzhou, 510030
Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University
Guangzhou, 510120
Nanfang Hospital
Guangzhou, 510515
Hainan General Hospital
Hainan, 570311
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009
Sir Run Run Shaw Hospital, Zhejiang University School of Medical
Hangzhou, 310020
Zhejiang Cancer Hospital
Hangzhou, 310022
The Affiliated Tumor Hospital of Harbin Medical University
Harbin, 150081
The First Hospital of Lanzhou University
Lanzhou, 730000
Linyi Cancer Hospital
Linyi, 276000
Nantong Tumor Hospital
Nantong, 226361
Shanghai Sixth people's hospital
Shanghai, 200025
Fudan University Shanghai Cancer Center
Shanghai, 200032
The Forth Hospital of Hebei Medical University
Shijiazhuang, 050011
Tianjin People's Hospital
Tianjin, 300000
Tianjin Medical University General Hospital
Tianjin, 300052
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, 221006
Henan Cancer Hospital
Zhengzhou, 450008
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052
About this study
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)
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)
Read the 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.
- Conditions
- Lymphoma, Follicular
- Being tested
- Abexinostat
- Keywords
- refractory, relapsed, lymph nodes
- Medical subject headings
- Lymphoma, Follicular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbexinostatDrug
Abexinostat tablets
| Study group | Role | What they receive |
|---|---|---|
| Abexinostat 80 mg bis in die (BID) | Experimental | 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 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
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 posted2 May 2019
- Study start22 Apr 2020
- Primary completion29 Jan 2025
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, FollicularStudies 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
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
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
- NCT03934567
- Sponsor's protocol ID
- XYN-605
- Status last verified
- Apr 2025
- First submitted
- 29 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 Oral Histone Deacetylase (HDAC)-Inhibitor Abexinostat, as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma (FL)
- ClinicalTrials.gov ID
- NCT03934567
- Acronym / sponsor ID
- XYN-605
- Conditions
- Lymphoma, Follicular
- Keywords
- refractory, relapsed, lymph nodes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Xynomic Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 2 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Abexinostat 80 mg bis in die (BID) | Experimental | Drug: AbexinostatExperimental: Abexinostat 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 (7 listed)
- 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);
Key exclusion criteria (13 listed)
- 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;
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 tablets | Drug | Abexinostat 80 mg bis in die (BID) |
Primary outcome
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
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. This study is not recruiting at the moment.
Yuankai SHI, Prof principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
26 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 Lymphoma, Follicular, run by Xynomic Pharmaceuticals, Inc. at 26 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 7 inclusion and 13 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: under way, not looking for participants, 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 26 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review (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.