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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Subjects will receive a single dose of 30 mg chidamide. Twice a week.
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City, Taiwan
NOT_YET_RECRUITINGKaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGTaichung Veterans General Hospital
Taichung, Taiwan
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
National Taiwan University Hospital
Taipei, Taiwan
NOT_YET_RECRUITINGChang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan
NOT_YET_RECRUITINGOverall survival (OS)
Overall Survival was the time from first administration of study treatment until the date of death.
Time frame: 24 months
Pharmacokinetics profiles - (AUC0-t)
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)
Pharmacokinetics profiles - (AUC0-∞)
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)
Pharmacokinetics profiles - (Cmax)
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)
Pharmacokinetics profiles - (Tmax)
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)
Pharmacokinetics profiles - (T1/2)
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)
Pharmacokinetics profiles - (Ctrough)
Pre-dose trough concentration (Ctrough)
Time frame: PK samples collected on Day 15, Day 18, and Day 22 predose (28 days/cycle)