Trial Title:
Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)
NCT ID:
NCT05833724
Condition:
Relapsed or Refractory Peripheral T-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Conditions: Keywords:
PTCL
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide
Description:
Subjects will receive a single dose of 30 mg chidamide. Twice a week.
Arm group label:
Chidamide
Other name:
Tucidinostat
Other name:
HBI-8000
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chang Gung Memorial Hospital, Kaohsiung
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Not yet recruiting
Investigator:
Last name:
Hung-Lin Liu, M.D.
Email:
Principal Investigator
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Country:
Taiwan
Status:
Recruiting
Investigator:
Last name:
Yi-Chang Liu, M.D.
Email:
Principal Investigator
Facility:
Name:
Taichung Veterans General Hospital
Address:
City:
Taichung
Country:
Taiwan
Status:
Not yet recruiting
Investigator:
Last name:
chieh-Lin Teng, M.D.
Email:
Principal Investigator
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Not yet recruiting
Investigator:
Last name:
Ming Yao, M.D.
Email:
Principal Investigator
Facility:
Name:
Chang Gung Memorial Hospital, Linkou
Address:
City:
Taoyuan
Country:
Taiwan
Status:
Not yet recruiting
Investigator:
Last name:
Hsiao-Wen Kao, M.D.
Email:
Principal Investigator
Start date:
April 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Great Novel Therapeutics Biotech & Medicals Corporation
Agency class:
Industry
Source:
Great Novel Therapeutics Biotech & Medicals Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05833724
