NCT07348575Enrolling By Invitation3 期
A Multicenter, Prospective, Randomized, Controlled Study of Decitabine in Combination With R-CHOP for Initial Treatment of EBV+ Diffuse Large B-cell Lymphoma
Second Affiliated Hospital of Nanchang University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年7月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 2-year progression-free survival
研究概览
简要总结
This trial was a prospective, multicenter, randomized, controlled Phase III clinical design to compare the efficacy and safety of decitabine combined with R-CHOP (R-CHOP-D) versus R-CHOP in the treatment of primary EBV+ diffuse large B-cell lymphoma (DLBCL).
Sixty patients were randomized 1:1 into R-CHOP-D (trial group) or R-CHOP (control group). The trial consisted of a screening period (days -28 to -1), a treatment period, and a follow-up period (2 years after the end of the last trial).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Initial treatment of diffuse large B-cell lymphoma (DLBCL) confirmed by tumor histopathology with at least one lesion on either axis More than 1.5 cm, sufficient specimens for second-generation sequencing or single-cell sequencing;
- •Age > 18 years old, < 80 years old, gender unlimited;
- •EBER+ or peripheral blood EBV-DNA of pathological specimen was greater than 103copy/ml;
- •Patients judged by the investigator to have a life expectancy of at least 6 months;
- •The patient or his legal representative must provide written informed consent prior to any research special examination or procedure.
- •Signed written informed consent before screening.
排除标准
- •Have previously received systemic or local treatment including chemotherapy;
- •Previously received autologous stem cell transplantation;
- •Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;
- •Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases and serious infectious diseases;
- •Lymphoma involves the central nervous system;
- •Primary mediastinal large B-cell lymphoma;
- •Left ventricular ejection fraction < 50%;
- •Laboratory test values at the time of screening: (unless due to lymphoma);
- •Neutrophils < 1.5 x 109/L;
- •Platelet < 75 x 109/L;
- •ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal;
- •creatinine levels higher than 1.5 times the upper limit of normal;
- •Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
- •Pregnant or lactating women;
- •Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (polymerase chain Reaction [PCR] showed positive results). If the HbsAg test result is positive, HBV DNA test should be performed, if the HBV DNA<103IU/ml, can be enrolled. If HBsAg test results are negative, but HBcAb test is positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA<103 IU/ml can be enrolled. If the patient's HCV antibody is positive, the HCV RNA is detected by PCR. If positive, the exclusion criteria are met.
- •Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.
研究组 & 干预措施
Decitabine in combination with R-CHOP
Experimental
Decitabine in combination with R-CHOP
干预措施: Decitabine in combination with R-CHOP (Drug)
R-CHOP
Active Comparator
R-CHOP
干预措施: R-CHOP (Drug)
结局指标
主要结局
2-year progression-free survival
时间窗: 2 year
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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