Phase II tucidinostat study for rrPTCL

JRCT ID: jRCTs061220060

Registered date:28/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: peripheral T-cell lymphoma
• Date of first enrollment: 18/10/2022
• Target sample size: 46
• Study type: Interventional
• 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

Outcome(s)

• Primary Outcome: Overall response rate

Secondary Outcome

Complete 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 maximum: Not applicable
• Gender: Both

Include criteria

1) 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 criteria

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

Related Information

• Primary Sponsor: Suzuki Ritsuro
• Source(s) of Monetary Support: Meiji Seika Pharma Co., Ltd.