Experimental drug chidamide targets Hard-to-Treat blood cancer
NCT ID NCT05833724
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This phase II trial tests the drug chidamide in people with peripheral T-cell lymphoma that has come back or stopped responding to treatment. The study aims to see if chidamide can shrink tumors and how safe it is. Participants take chidamide twice a week, and doctors monitor their response using scans and clinical exams.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chidamide (also called Tucidinostat or HBI-8000)
- What this could lead to
- If successful, chidamide could offer a new treatment option for people with this rare and aggressive blood cancer that has not responded to other therapies.
- What could go wrong
- This is a small, early-phase trial with only 33 participants, so results may not apply to everyone. The drug may cause side effects and may not shrink tumors in all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chang Gung Memorial Hospital, Kaohsiung
RECRUITINGKaohsiung City, Taiwan
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Chang Gung Memorial Hospital, Linkou
RECRUITINGTaoyuan, Taiwan
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Far eastern memorial hospital
RECRUITINGNew Taipei City, 220, Taiwan
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Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITINGKaohsiung City, Taiwan
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National Taiwan University Hospital
RECRUITINGTaipei, Taiwan
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Taichung Veterans General Hospital
RECRUITINGTaichung, Taiwan
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