NCT01009970Unknown2 期
Multicenter Study of Phase II With Rituximab, Cyclophosphamide, Doxorubicin Liposomal (Myocet ®), Vincristine, Prednisone, (R-COMP) in Non-Hodgkin's Lymphoma Diffuse Large B Cell in Cardiopathic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 32
- 主要终点
- Feasibility of R-COMP in cardiopathic patients
研究概览
简要总结
This is a multicenter study phase II, open-label for cardiopathic patients affected by Non-Hodgkin's lymphoma diffuse large B cell CD20 + grade IIIb follicular. The purpose is to study the feasibility of R-COMP in this cohort of patients.
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 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL;
- •Age >= 18 years;
- •Presence of at least 1 factor that defines the cardiopathy;
- •Life expectancy > 3 months;
- •In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy;
- •Written informed consent.
排除标准
- •Histology different from NHL diffuse large cell CD20 + or follicular IIIb
- •Age < 18 years
- •Inability to sign informed consent;
- •HIV positivity;
- •Patients HBsAg positive;
- •AST/ALT > 2 times the standard;
- •Bilirubin > 2 times the standard;
- •Creatinine > 2.5 mg / dl;
- •Location of CNS disease;
- •Pregnancy ongoing;
- •Damage to that organ or medical problems that could interfere with the therapy;
- •Current uncontrolled infection;
- •Senile dementia
研究组 & 干预措施
1
Experimental
R-COMP
干预措施: Cyclophosphamide (Drug)
1
Experimental
R-COMP
干预措施: Rituximab (Drug)
1
Experimental
R-COMP
干预措施: Vincristine (Drug)
1
Experimental
R-COMP
干预措施: Prednisone (Drug)
1
Experimental
R-COMP
干预措施: Doxorubicin (Drug)
结局指标
主要结局
Feasibility of R-COMP in cardiopathic patients
时间窗: 2 years
次要结局
- Response rates(1 year)
- Progression free survival(2 years)
- Overall Survival(3 years)
研究者
研究点 (32)
Loading locations...
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