Chidamide With R-CHOP Regimen for de Novo, High Risk Diffuse Large B Cell Lymphoma (DLBCL): A Prospective, Signal Arm, Open Label Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- complete remission rate
研究概览
简要总结
It's a prospective, single arm, open label phase II clinical trial, in which the safety and efficacy of Chidamide plus R-CHOP regimen is accessed in de novo DLBCL patients, who have received 2 courses of R-CHOP but only achieved PR or whose MRD tests for ctDNA revealed positive results.
abbreviation: R-CHOP: the chemo-therapy regimen composed of Rituximab, cyclophosphoamide, etoposide, vincristine and prednisone.
PR: partial remission; MRD:minimal residual disease;
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results;
- •Age between 18 to 75 years old;
- •World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2;
- •No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment;
- •Life expectancy no less than 6 months
- •The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures;
- •IPI mark>1.
排除标准
- •History of autologous stem cell transplantation;
- •History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;
- •With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;
- •Lymphoma originated in the central nervous system;
- •Left ventricular ejection fraction ≦50％
- •Abnormal lab results in enrollment:
- •Neutrophil count: <1.5*109/L；
- •Platelet count <75*109/L；
- •AST or ALT >2 times the upper limit of normal level，AKP and total bilirubin >1.5 times the upper limit of normal level;
- •serum creatinine >1.5 times the upper limit of normal level;
- •Other uncontrolled medical conditions which the investigators think might influence the results of the trial;
- •Patients with mental illnesses or other diseases that might not comply with the trial plan;
- •Women during pregnancy or lactation;
- •HIV positive patients;
- •HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative;
研究组 & 干预措施
treatment group
In this group, the patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1; CTX 750mg/m2, ivgtt,d2; EPI 70mg/m2, ivgtt,d2; VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2, PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18; one cycle every 21 days； abbreviation： CTX： cyclophosphamide；EPI：etoposide；VCR： vincristine；Pred：prednisone； R-CHOP：the chemo-therapy regimen composed of Rituximab, cyclophosphoamide; etoposide, vincristine and prednisone.
干预措施: Chidamide + R-CHOP regimen (Drug)
结局指标
主要结局
complete remission rate
时间窗: every 3 months until 30 months after the last patient's enrollment
complete remission rate after treated by Chidamide+ R-CHOP regimen
次要结局
- adverse events(from the date of first cycle of treatment to 30 months after last patient's enrollment)
- overall survival(30 months after the last patient's enrollment)
- progression free survival(from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment)
研究者
Wenbin Qian
Chief of lymphoma center
First Affiliated Hospital of Zhejiang University