Peripheral T-cell Lymphoma
Conditions
Interventions
Case series:Chidamade
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histopathological diagnosis of peripheral T cell lymphoma according to WHO 2016 criteria; 2. Aged 18 to 75 years; 3. ECOG 0~2; 4. Patients responded to CHOP-like first-line chemotherapy regimens (including CR, PR) and are not suitable or considered for bone marrow transplantation; 5. The Blood routine and biochemistry test meet the following criteria within 7 days before treatment: HB =80g/L, ANC =1.5×109/L, PLT =60×109/L; TBIL =1.5 ULN, ALT and AST=2.5 ULN, Cr =1.5 ULN, CCr =60ml/min; 6. LVEF = 50%LLN; 7. Men and women of childbearing age agree to adopt a reliable contraception during the entire study period and within 4 weeks after the end of study treatment; 8. Participate in this study voluntarily and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Previously received chidamide or other HDACi drugs; 2. Previously received received more than one line of chemotherapy, or had received any treatment other than CHOP like chemotherapy, or 12 weeks after the completion of first-line chemotherapy; 3. Pathological diagnosis of extranodal NK/T-cell lymphoma, ALK-positive anaplastic large cell lymphoma (ALCL, ALK(+)), central nervous system lymphoma or patients with HIV-associated lymphoma; 4. Have or have had an active malignancy in the past 5 years; 5. Receiving or receiving a therapeutic dose of systemic steroid therapy within 2 weeks prior to enrollment, allowing the use of low dose steroids [dexamethasone or equivalent] up to 10 mg/day for the treatment of non-neoplastic diseases; 6. Previously treated patients who had received doxorubicin or equivalent to 450mg/m2 cumulative dose, the formula was calculated: [(X/450+Y/160) > 1], of which X was the dose of mg/ M2 adriamycin, and Y was the dose of mg/m2 mitoxantrone; 7. Other research drugs were used for treatment within 4 weeks prior to enrollment; 8. For pregnant or lactating women (any woman who is pregnant during the study period should withdraw from the study immediately); 9. A serious infection, medical condition or mental condition occurs, which the investigator believes may interfere with the achievement of the research purpose; 10. Having human immunodeficiency virus (HIV), active hepatitis; 11. Clinically significant cardiovascular abnormalities (New York Heart Association (NYHA) classification: III/IV), myocardial infarction within 6 months prior to enrollment, malignant arrhythmia (including QTC = 480ms), use of antihypertensive drugs Patients with uncontrolled blood pressure (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg) and uncontrolled angina pectoris; 12. Those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder; 13. According to the researchers' judgment, there are serious diseases that endanger patients' safety or affect patients' completion of research.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| safety;overall surviral;The percentage of conversion from partial remission to complete remission; | — |
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Countries
China
Contacts
Public ContactLiqun Zou
West China Hospital, Sichuan University
Outcome results
None listed