Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 2 years progression-free survival
研究概览
简要总结
The purpose of this study is to determine determine the maximum tolerated dose (MTD) and safety of the combination of Chidamide combined with CHOEP(cyclophosphamide， epirubicin,vindesine, etoposide and prednisone) regimen as first line treatment in newly-diagnosed T-NHL.
详细描述
Chidamide+Cyclophosphamide+Epirubicin+Vindesine+Etoposide+Prednisone Six cycles of therapy administered every 28 days were planned. Cyclophosphamide 750mg/m2 IV d1; epirubicin 70mg/m2 IV d1; Vindesine 4mg IV d1; etoposide 100mg IV d1-3; prednisone 60mg/m2 PO d1-5.
Chidamide:
Phase I: Patients were treated at the following bortezomib dose levels: 15, 20, and 25 mg twice per week.
Dose escalation and reduction were on the basis of the continual reassessment method, with at least two patients per dose level and no dose level skipped. No intrapatient dose escalation will be allowed. If one patient experienced dose-limiting toxicity (DLT), three additional patients were added to the dose level. If two of six patients experienced DLT, the previous dose level was declared the MTD. If only one of six patients experienced DLT, dose escalation was permitted to continue. DLT refers only to toxic events that occur during the first cycle of treatment.
At least 9(3+3+3) patients will be enrolled in Phase I study. Phase II: If MTD was not reached at 25mg dose level of Chidamide. The followed study will use 20mg twice per week as experimental dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly-diagnosed T cell non-Hodgkin's lymphoma patients. Diagnosis of T cell NHL was performed by morphologic analysis of tissue pathological specimens along with Immunohistochemistry (IHC)
- •At least one or more unidimensionally measurable lesions (≥1 cm by CT scan or skin lesions or a measurable lesion by physical examination)
- •Sign the Informed consent
- •Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.
- •Male subjects must agree to use condoms throughout study drug therapy.
排除标准
- •T lymphoblastic leukemia/lymphoma
- •Bone marrow involvement and lymphoma cell ≥ 25%
- •Aplastic large T cell lymphoma - ALK positive
- •NK/T-cell lymphoma
- •Mycosis Fungoides/Sezary Syndrome
- •Pre-existing uncontrolled active infection
- •Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria
- •Grade 3 or 4 peripheral neuropathy
- •Pregnancy or active lactation
- •Co-existing tumors
- •Impaired renal/ hepatic function (serum creatinine >1.5 mg/dl or creatinine clearance <60 ml/min or serum transaminases/ bilirubin ≥3 upper limits of normal）
- •History of mental illness
研究组 & 干预措施
C-CHOEP
experimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles.
干预措施: Chidamide (Drug)
C-CHOEP
experimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles.
干预措施: Cyclophosphamide (Drug)
C-CHOEP
experimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles.
干预措施: Epirubicin (Drug)
C-CHOEP
experimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles.
干预措施: Vindesine (Drug)
C-CHOEP
experimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles.
干预措施: Etoposide (Drug)
C-CHOEP
experimental arm will be treated by Chidamide combined CHOEP ( cyclophosphamide, epirubicine, vindesine, etoposide and prednisone) regimen for 6 cycles.
干预措施: Prednisone (Drug)
结局指标
主要结局
2 years progression-free survival
时间窗: the overall time frame is up to 48 months
from recruiting the first subject until the last recruited subject finished his 2 years follow-up phase or the disease relapsed
次要结局
- overall response rate(ORR) and complete remission rate(CR）(the overall time frame is up to 30 months)
- 5 years overall survival（OS）(the overall time frame is up to 84 months)
- adverse events(the overall time frame is up to 84 months)