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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)

A Phase II, Open-label, Single-arm, Multicenter Study of Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL) (NCT05833724) is a Phase 2 interventional studying Relapsed or Refractory Peripheral T-cell Lymphoma, sponsored by Great Novel Therapeutics Biotech & Medicals Corporation. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Relapsed or Refractory Peripheral T-cell Lymphoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 33 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. 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. 2. Patients for whom at least one measurable lesion according to Cheson Criteria 2014 at baseline. 3. Relapsed or refractory disease (including DOR shorter than 30 days) to ≥1 previous cancer treatment that works throughout the body (like chemotherapy) including, but not limited to, chemotherapy, target therapy, immunotherapy, and autologous stem cell transplantation. 4. Male or female, aged 20-75 years (inclusive). 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. With a life expectancy of ≥12 weeks. 7. Have not received radiotherapy, chemotherapy, immunotherapy (except for antibody therapy), or target therapy within 4 weeks prior to the start of study drug. 8. Have not received any antibody therapy within 12 weeks prior to the start of study drug. 9. Willing to provide written willing to sign a consent form. Who Should NOT Join This Trial: 1. Females who are pregnant or breastfeeding, or females of childbearing potential who are not willing to use adequate contraception. 2. Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm). 3. Have been treated with histone deacetylase (HDAC) inhibitor. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 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. 2. Patients for whom at least one measurable lesion according to Cheson Criteria 2014 at baseline. 3. 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. 4. Male or female, aged 20-75 years (inclusive). 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. With a life expectancy of ≥12 weeks. 7. Have not received radiotherapy, chemotherapy, immunotherapy (except for antibody therapy), or target therapy within 4 weeks prior to the start of study drug. 8. Have not received any antibody therapy within 12 weeks prior to the start of study drug. 9. Willing to provide written informed consent. Exclusion Criteria: 1. Females who are pregnant or breastfeeding, or females of childbearing potential who are not willing to use adequate contraception. 2. Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm). 3. Have been treated with histone deacetylase (HDAC) inhibitor. 4. 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. 5. The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10 mm during diastolic period. 6. With a history of organ transplantation. 7. With a history of allogeneic stem cell transplantation. 8. Have received autologous stem cell transplantation within 12 weeks prior to the start of study drug. 9. 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. 10. Have received symptomatic treatment for early myelotoxicity within 7 days prior to the start of study drug. 11. With active bleeding or newly diagnosed thromboembolic disease, or with hemorrhagic tendency who are using anticoagulants. 12. With active infection of hepatitis B or C, or persistent fever within 14 days prior to the start of study drug. 13. With history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome. 14. Had a major organ surgery within 6 weeks prior to the start of study drug. 15. 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). 16. 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. 17. Considered by the investigator as being not suitable to participate the study.

Treatments Being Tested

DRUG

Chidamide

Subjects will receive a single dose of 30 mg chidamide. Twice a week.

Locations (5)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05833724), the sponsor (Great Novel Therapeutics Biotech & Medicals Corporation), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05833724 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05833724?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05833724?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05833724. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05833724. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.