NIPH Clinical Trials Search

JRCT ID: jRCTs061220060

Registered date:28/09/2022

Phase II tucidinostat study for rrPTCL

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedperipheral T-cell lymphoma
Date of first enrollment18/10/2022
Target sample size46
Countries of recruitment
Study typeInterventional
Intervention(s)tucidinostat 40 mg (10 mg tablets x 4), orally, 30 minutes after any regular meal BIW, each dose separated by 3 to 4 days


Primary OutcomeOverall response rate
Secondary OutcomeComplete response rate (%CR) Progression-free survival (PFS) Overall survival (OS) Duration of response (DOR) PFS, OS, DOR by histological subtype PFS, OS, DOR by treatment response Adverse events

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1) Relapsed or refractory peripheral t-cell lymphoma, histologically confirmed by the following (WHO 2017); - Peripheral T-cell lymphoma, NOS - AITL - Follicular T-cell lymphoma - Nodal peripheral T-cell lymphoma with T follicular helper phenotype - Anaplastic large cell lymphoma, ALK-positive - Anaplastic large cell lymphoma, ALK-negative 2) Prior history of at least one chemotherapy treatment (excluding radiotherapy alone and steroid alone) 3) Aged 20 years or older at the time of informed consent 4) Eastern Cooperative Oncology Group (ECOG) performance status score 0-3 5) At least one bi-dimensionally measurable lesion on imaging scan (Measurable in two orthogonal directions with CT scan, and maximum diameter of the tumor is more than 1.5 cm) 6) Absolute bone marrow, liver, and renal function, which meet the following before treatment initiation - Neutrophil count (ANC) >= 1,500 /mm3 - Platelets >= 75,000 /mm3 - T-bil =< upper limit of normal (ULN) x 1.5 mg/dl - AST =< ULN x 3 U/L, ALT =< ULN x 3 U/L - Cre < UNL x 1.5 mg/dl 7) Patients who provided written informed consent
Exclude criteria1) Histologically and/or clinically proven or suspected cerntral nervous system involvement 2) Ischemic chages or QT prolongation (Male, QT >450msec; Female, QT >470msec, calculated by Fridericia formula) detected by electrocardiogram 3) History of myocardial infarction within the last 6 months, unstable angina, chronic heart failure (NYHA III or IV), dilated cardiomyopathy, or restrictive cardiomyopathy 4) History of congenital long QT syndrome, atrial fibrillation, ventricular arrhythmia which requrires treatement, or critical arrhythmia such as ventricular flutter or ventricular fibrillation 5) History of interstitial pneumonia, pulmonary fibrosis, or severe pulmonary emphysema 6) Positive test results for hepatitis B surface (HBs) antigen 7) Accompanied by severe infection 8) Women who have a possibility of pregnant or who are breastfeed 9) Prior history of other kind of malignancies, unless the patient has been free for at least 5 years 10) History of hypersensitivity for benzamide-based compounds or components of tucidinostat, or prior treament by tucidinostat 11) History of other treatments or anti-cancer agents within the last 28 days of treatment initiation of the current study 12) Any serious medical condition, laboratory abnormality or psychiatric illness that the investigator or sub-investigator would judge inadequate to participate

Related Information


Public contact
Name Ayumi Fujimoto
Address 89-1,Enya-cho, Izumo-shi, Shimane Shimane Japan 693-8501
Telephone +81-853-20-2308
Affiliation Shimane University Hospital
Scientific contact
Name Ritsuro Suzuki
Address 89-1,Enya-cho, Izumo-shi, Shimane Shimane Japan 693-8501
Telephone +81-853-20-2308
Affiliation Shimane University Hospital