Actively Recruiting
Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)
Led by Great Novel Therapeutics Biotech & Medicals Corporation · Updated on 2025-03-11
33
Participants Needed
5
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological diagnosis of specific PTCL subtypes confirmed by the investigator, excluding cutaneous or leukemic forms
- At least one measurable lesion based on Cheson Criteria 2014 at baseline
- Relapsed or refractory disease after at least one prior systemic therapy including chemotherapy, targeted therapy, immunotherapy, or autologous stem cell transplantation
- Male or female aged 20 to 75 years inclusive
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- No radiotherapy, chemotherapy, immunotherapy (except antibody therapy), or targeted therapy within 4 weeks before starting the study drug
- No antibody therapy within 12 weeks before starting the study drug
- Willingness to provide written informed consent
You will not qualify if you...
- Pregnant or breastfeeding females or females of childbearing potential unwilling to use adequate contraception
- Central nervous system lymphoma detected during screening
- Prior treatment with histone deacetylase (HDAC) inhibitors
- History of significant heart conditions including QTc prolongation, ventricular tachycardia, atrial fibrillation, heart block, recent myocardial infarction, congestive heart failure, or symptomatic coronary artery disease
- Fluid accumulation in the pericardium exceeding 10 mm during diastole
- History of organ transplantation or allogeneic stem cell transplantation
- Autologous stem cell transplantation within 12 weeks prior to study drug start
- Participation in other clinical trials involving investigational antibody therapy within 12 weeks or non-antibody therapy within 4 weeks prior to study drug start
- Symptomatic treatment for early myelotoxicity within 7 days prior to study drug start
- Active bleeding, thromboembolic disease, or hemorrhagic tendency with anticoagulant use
- Active hepatitis B or C infection, or persistent fever within 14 days prior to study drug start
- Positive HIV test or diagnosis of AIDS
- Major organ surgery within 6 weeks prior to study drug start
- Abnormal liver, kidney function, or blood counts beyond specified limits
- Known psychiatric or substance abuse disorders interfering with participation
- Investigator's judgment deeming participant unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City, Taiwan
Not Yet Recruiting
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
3
Taichung Veterans General Hospital
Taichung, Taiwan
Not Yet Recruiting
4
National Taiwan University Hospital
Taipei, Taiwan
Not Yet Recruiting
5
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan
Not Yet Recruiting
Research Team
C
Chia-Nan Chen, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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