Phase II study of tucidinostat monotherapy for relapsed or refractory peripheral T-cell lymphoma - HMCSG-Tucidinostat-rrPTC

Suzuki Ritsuro0 个研究点目标入组 46 人开始时间: 2022年9月28日最近更新: 2024年4月23日

试验速览

暂无简介。

•1) Relapsed or refractory peripheral t-cell lymphoma, histologically confirmed by the following (WHO 2017);
•- Peripheral T-cell lymphoma, NOS
•- 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

•1) 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

发起方

Suzuki Ritsuro