Relapsed or Refractory Peripheral T-cell LymphomaPhase 2NCT05833724
Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)
A Phase 2 study testing Chidamide in people with Relapsed or Refractory Peripheral T-cell Lymphoma, run by Great Novel Therapeutics Biotech & Medicals Corporation at 6 sites in Taiwan.
Trial summary
This is a phase II, open-label, non-randomized, single-arm, multicenter study to evaluate the efficacy, safety, and PK of chidamide in patients with R/R PTCL. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Relapsed or Refractory Peripheral T-cell Lymphoma
- What is being tested?
- Chidamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 6 sitesTaiwan
- Study dates
- 18 Oct 2024to Dec 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological diagnosis, made by the investigator, of the following PTCL subtypes as defined by the WHO classification (2016) may be included: PTCL, not otherwise specified (PTCL-NOS), anaplastic lymphoma kinase-positive (ALK+) anaplastic large-cell lymphoma (ALCL), ALK-negative (ALK-) ALCL, angioimmunoblastic T-cell lymphoma (AITL), extranodal natural killer (NK)/T-cell lymphoma, nasal type (ENKL), etc., except cutaneous form or leukemic form.
- Patients for whom at least one measurable lesion according to Cheson Criteria 2014 at baseline.
- Relapsed or refractory disease (including DOR shorter than 30 days) to ≥1 prior systemic therapy including, but not limited to, chemotherapy, target therapy, immunotherapy, and autologous stem cell transplantation.
- Male or female, aged 20-75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- With a life expectancy of ≥12 weeks.
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- Have not received radiotherapy, chemotherapy, immunotherapy (except for antibody therapy), or target therapy within 4 weeks prior to the start of study drug.
- Have not received any antibody therapy within 12 weeks prior to the start of study drug.
- Willing to provide written informed consent.
Who cannot join
- Females who are pregnant or breastfeeding, or females of childbearing potential who are not willing to use adequate contraception.
- Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm).
- Have been treated with histone deacetylase (HDAC) inhibitor.
- With a history of clinically significant QTc prolongation (>450 ms for males or >470 ms for females), ventricular tachycardia (VT), atrial fibrillation (AF), heart block (HB), myocardial infarction (MI) onset within one year, congestive heart failure (CHF), or any other symptomatic coronary artery disease requiring treatment.
- The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10 mm during diastolic period.
- With a history of organ transplantation.
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- With a history of allogeneic stem cell transplantation.
- Have received autologous stem cell transplantation within 12 weeks prior to the start of study drug.
- Have participated in a clinical trial involving investigational antibody therapy within 12 weeks prior to the start of study drug or non-antibody therapy within 4 weeks prior to the start of study drug.
- Have received symptomatic treatment for early myelotoxicity within 7 days prior to the start of study drug.
- With active bleeding or newly diagnosed thromboembolic disease, or with hemorrhagic tendency who are using anticoagulants.
- With active infection of hepatitis B or C, or persistent fever within 14 days prior to the start of study drug.
- With history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome.
- Had a major organ surgery within 6 weeks prior to the start of study drug.
- With abnormal hepatic function (serum total bilirubin >1.5 x upper limit of normal [ULN]; alanine aminotransferase [ALT]/aspartate aminotransferase [AST] >2.5 x ULN or >5 x ULN if liver metastases are present), abnormal renal function (serum creatinine >1.5 x ULN), or abnormal complete blood count (absolute neutrophil counts <1500/μL; platelet counts <90 x 1000/μL, hemoglobin <9 g/dL).
- Has known psychiatric disorders or substance abuse disorders that may interfere with the patient's participation in the study or evaluation of the study results.
- Considered by the investigator as being not suitable to participate the study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Taiwan6 sites, 6 recruiting
- Recruiting
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City
Hung-Lin Liu, M.D.
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Yi-Chang Liu, M.D.
- Recruiting
Far eastern memorial hospital
New Taipei City, 220
Yuan-Bin Yu, M.D.
- Recruiting
Taichung Veterans General Hospital
Taichung
Chieh-Lin Teng, M.D.
- Recruiting
National Taiwan University Hospital
Taipei
Ming Yao, M.D.
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan
Hsiao-Wen Kao, M.D.
About this study
Official title: A Phase II, Open-label, Single-arm, Multicenter Study of Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
This is a phase II, open-label, non-randomized, single-arm, multicenter study to evaluate the efficacy, safety, and PK of chidamide in patients with R/R PTCL.
Read the detailed description
This is a phase II, open-label, non-randomized, single-arm, multicenter study to evaluate the efficacy, safety, and PK of chidamide in patients with R/R PTCL. To determine eligibility, subjects must have PTCL confirmed with a sample or specimen evaluated by the investigator.A treatment cycle is defined as 4 weeks. All eligible subjects will be treated with chidamide until disease progression, intolerable toxicity effects, death, or withdrawal of consent.
- Being tested
- Chidamide
- Keywords
- PTCL
- Medical subject headings
- Recurrence, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Also called Tucidinostat, HBI-8000
Subjects will receive a single dose of 30 mg chidamide. Twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide | Experimental | Chidamide tablets orally, twice a week. Receives: Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to International Working Group (IWG) criteria. The response was assessed based on clinical and radiological criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. As pre-defined, the primary endpoint analysis for this study was based on the Independent Overall Efficacy Review Committee (IOERC) assessment of response.
Measured: 24 months
Secondary outcomes (10)
Time to response (TTR)
Time to response was defined as the time (in weeks) from first administration of treatment until first response. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.
Measured: 24 months
Duration of response (DOR)
The Duration of Response was assessed by IWG criteria per the IRC from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.
Measured: 24 months
Progression-free survival (PFS)
Progression-free survival (PFS) was the duration of time from first administration of study treatment to date of first documented progression or death from any cause. It was based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Measured: 24 months
Overall survival (OS)
Overall Survival was the time from first administration of study treatment until the date of death.
Measured: 24 months
Pharmacokinetics profiles - (AUC0-t)
Area under the plasma concentration-time curve from time zero to time t(AUC0-t)
Measured: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (AUC0-∞)
Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)
Measured: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (Cmax)
Maximum plasma concentration(Cmax)
Measured: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (Tmax)
Time to maximum plasma concentration(Tmax)
Measured: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (T1/2)
Half-life(T1/2)
Measured: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (Ctrough)
Pre-dose trough concentration (Ctrough)
Measured: PK samples collected on Day 15, Day 18, and Day 22 predose (28 days/cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start18 Oct 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Peripheral T-cell LymphomaStudies 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
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Novel Therapeutics Biotech & Medicals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia-Nan Chen, Ph.D., Study director, Great Novel Therapeutics Biotech & Medicals Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833724
- Sponsor's protocol ID
- KEPIDA-2
- Status last verified
- Jul 2026
- First submitted
- 17 Apr 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Single-arm, Multicenter Study of Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05833724
- Acronym / sponsor ID
- KEPIDA-2
- Keywords
- PTCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Great Novel Therapeutics Biotech & Medicals CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Apr 2023 (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.
This is a phase II, open-label, non-randomized, single-arm, multicenter study to evaluate the efficacy, safety, and PK of chidamide in patients with R/R PTCL.
Detailed description
This is a phase II, open-label, non-randomized, single-arm, multicenter study to evaluate the efficacy, safety, and PK of chidamide in patients with R/R PTCL. To determine eligibility, subjects must have PTCL confirmed with a sample or specimen evaluated by the investigator.A treatment cycle is defined as 4 weeks. All eligible subjects will be treated with chidamide until disease progression, intolerable toxicity effects, death, or withdrawal of consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide | Experimental | Drug: ChidamideChidamide tablets orally, twice a week. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histopathological diagnosis, made by the investigator, of the following PTCL subtypes as defined by the WHO classification (2016) may be included: PTCL, not otherwise specified (PTCL-NOS), anaplastic lymphoma kinase-positive (ALK+) anaplastic large-cell lymphoma (ALCL), ALK-negative (ALK-) ALCL, angioimmunoblastic T-cell lymphoma (AITL), extranodal natural killer (NK)/T-cell lymphoma, nasal type (ENKL), etc., except cutaneous form or leukemic form.
- Patients for whom at least one measurable lesion according to Cheson Criteria 2014 at baseline.
- Relapsed or refractory disease (including DOR shorter than 30 days) to ≥1 prior systemic therapy including, but not limited to, chemotherapy, target therapy, immunotherapy, and autologous stem cell transplantation.
- Male or female, aged 20-75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Key exclusion criteria (17 listed)
- Females who are pregnant or breastfeeding, or females of childbearing potential who are not willing to use adequate contraception.
- Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm).
- Have been treated with histone deacetylase (HDAC) inhibitor.
- With a history of clinically significant QTc prolongation (>450 ms for males or >470 ms for females), ventricular tachycardia (VT), atrial fibrillation (AF), heart block (HB), myocardial infarction (MI) onset within one year, congestive heart failure (CHF), or any other symptomatic coronary artery disease requiring treatment.
- The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10 mm during diastolic period.
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 |
|---|---|---|
| ChidamideAlso: Tucidinostat, HBI-8000Subjects will receive a single dose of 30 mg chidamide. Twice a week. | Drug | Chidamide |
Primary outcome
Objective response rate (ORR)
Time frame: 24 months
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to International Working Group (IWG) criteria. The response was assessed based on clinical and radiological criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. As pre-defined, the primary endpoint analysis for this study was based on the Independent Overall Efficacy Review Committee (IOERC) assessment of response.
10 secondary outcomes
Time to response (TTR)
Time frame: 24 months
Duration of response (DOR)
Time frame: 24 months
Progression-free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Pharmacokinetics profiles - (AUC0-t)
Time frame: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (AUC0-∞)
Time frame: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (Cmax)
Time frame: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (Tmax)
Time frame: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (T1/2)
Time frame: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)
Pharmacokinetics profiles - (Ctrough)
Time frame: PK samples collected on Day 15, Day 18, and Day 22 predose (28 days/cycle)
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 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Chia-Nan Chen, Ph.D. study director
Great Novel Therapeutics Biotech & Medicals Corporation
6 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 Chidamide in people with Relapsed or Refractory Peripheral T-cell Lymphoma, run by Great Novel Therapeutics Biotech & Medicals Corporation at 6 sites in Taiwan.
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 9 inclusion and 17 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. 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 Chia-Nan Chen, Ph.D. (886-2-2785-1399, alex.chen@gntbm.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 24 months). 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 7 Jul 2026.