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

Primary Purpose

Relapsed or Refractory Peripheral T-cell Lymphoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Chidamide
Sponsored by
Great Novel Therapeutics Biotech & Medicals Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Peripheral T-cell Lymphoma focused on measuring PTCL

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide

Arm Description

Chidamide tablets orally, twice a week.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Overall survival (OS)
Overall Survival was the time from first administration of study treatment until the date of death.
Pharmacokinetics profiles - (AUC0-t)
Area under the plasma concentration-time curve from time zero to time t(AUC0-t)
Pharmacokinetics profiles - (AUC0-∞)
Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)
Pharmacokinetics profiles - (Cmax)
Maximum plasma concentration(Cmax)
Pharmacokinetics profiles - (Tmax)
Time to maximum plasma concentration(Tmax)
Pharmacokinetics profiles - (T1/2)
Half-life(T1/2)
Pharmacokinetics profiles - (Ctrough)
Pre-dose trough concentration (Ctrough)

Full Information

First Posted
April 17, 2023
Last Updated
April 17, 2023
Sponsor
Great Novel Therapeutics Biotech & Medicals Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05833724
Brief Title
Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)
Official Title
A Phase II, Open-label, Single-arm, Multicenter Study of Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Novel Therapeutics Biotech & Medicals Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Peripheral T-cell Lymphoma
Keywords
PTCL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chidamide
Arm Type
Experimental
Arm Description
Chidamide tablets orally, twice a week.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Other Intervention Name(s)
Tucidinostat, HBI-8000
Intervention Description
Subjects will receive a single dose of 30 mg chidamide. Twice a week.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Time to response (TTR)
Description
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.
Time Frame
24 months
Title
Duration of response (DOR)
Description
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.
Time Frame
24 months
Title
Progression-free survival (PFS)
Description
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.
Time Frame
24 months
Title
Overall survival (OS)
Description
Overall Survival was the time from first administration of study treatment until the date of death.
Time Frame
24 months
Title
Pharmacokinetics profiles - (AUC0-t)
Description
Area under the plasma concentration-time curve from time zero to time t(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)
Title
Pharmacokinetics profiles - (AUC0-∞)
Description
Area under the plasma concentration-time curve from time zero to infinity(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)
Title
Pharmacokinetics profiles - (Cmax)
Description
Maximum plasma concentration(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)
Title
Pharmacokinetics profiles - (Tmax)
Description
Time to maximum plasma concentration(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)
Title
Pharmacokinetics profiles - (T1/2)
Description
Half-life(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)
Title
Pharmacokinetics profiles - (Ctrough)
Description
Pre-dose trough concentration (Ctrough)
Time Frame
PK samples collected on Day 15, Day 18, and Day 22 predose (28 days/cycle)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Nan Chen, Ph.D.
Phone
886-2-77220388
Email
alex.chen@gntbm.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Nan Chen, Ph.D.
Organizational Affiliation
Great Novel Therapeutics Biotech & Medicals Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Kaohsiung
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Chang Liu, M.D.
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Yao, M.D.
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiao-Wen Kao, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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