A Non-interventional Study on the Relationship Between Gene Abnormalities and the Efficacy and Prognosis in Patients With Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The relationship of ORR, progression free survival, overall survival of patients with standard treatment with gene abnormalities
研究概览
简要总结
to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing and analyze the relationship between this gene abnormalities and the efficacy and prognosis in diffuse large B cell lymphoma.
详细描述
This is one arm, single center non-intervention study. New diagnosed diffuse large B cell lymphoma patients were enrolled to detect the translocation of c-Myc, Bcl-2 and Bcl-6 by FISH and 481 gene mutation by next generation sequencing, then patients received standard treatment with R-CHOP, R2CHOP and DA-EPOCH by investigate's choice according to the patients pathological characteristics. the basic characteristics and treatment response and progression-free survival and overall survival were collected and analyzed with the gene abnormalities. a total of 100 diffuse large B cell lymphoma patients will enrolled in one year and will finish after 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG PS 0-2;
- •histological diagnosed diffuse large B cell lymphoma;
- •normal hematological, hepatal, renal function;
- •normal heart function with LVEF ≥ 50%;
排除标准
- •Diagnosed as a malignant tumor other than lymphoma or receiving treatment, except for the following conditions:
- •①Have received treatment for the purpose of curing, and no malignant tumor with known active disease occurred ≥5 years before enrollment;
- •②Skin basal cell carcinoma (except melanoma) that has received adequate treatment and has no signs of disease;
- •③ Carcinoma in situ of the cervix that has received adequate treatment and has no signs of disease.
- •Heart disease with clinical significance, including unstable angina pectoris, acute myocardial infarction within 6 months before screening.
- •Congestive heart failure (NYHA) heart function is graded in grade III or IV (Annex 3)
- •Severe arrhythmia requiring treatment.
- •Patients with active hepatitis B and HIV infection.
- •Women who are pregnant or breastfeeding
- •Patients who have received organ transplants in the past
- •Patients with severe active infection
- •Have a history of severe neurological or psychiatric diseases, including dementia or epilepsy
结局指标
主要结局
The relationship of ORR, progression free survival, overall survival of patients with standard treatment with gene abnormalities
时间窗: 3 years
the incidence of gene mutation in DLBCL
时间窗: 3 years
The incidence of gene mutation in different subtype of DLBCL
时间窗: 3years
次要结局
未报告次要终点
研究者
Junning Cao, MD
Chief Physician
Fudan University