NCT04025593Unknown2 期
A Randomized, Phase 2 Study of Biomarker Guided Treatment in DLBCL
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- complete response rate
研究概览
简要总结
This study is to investigate the strategy of biomarker guided treatment in diffuse large B cell lymphoma
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed diffuse large B-cell lymphoma, CD20 positive
- •ECOG 0,1,2
- •Life expectancy>6 months
- •Informed consented
排除标准
- •Chemotherapy before
- •Stem cell transplantation before
- •History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- •Primary CNS lymphoma
- •Lab at enrollment (Unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<75*10^9/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN Other uncontrollable medical condition that may that may interfere the participation of the study Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation HIV infection If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
研究组 & 干预措施
RCHOP
Active Comparator
干预措施: Vincristine (Drug)
RCHOP
Active Comparator
干预措施: Prednisone (Drug)
RCHOPX
Experimental
干预措施: Cyclophosphamide (Drug)
RCHOPX
Experimental
干预措施: Rituximab (Drug)
RCHOPX
Experimental
干预措施: Doxorubicin (Drug)
RCHOPX
Experimental
干预措施: Vincristine (Drug)
RCHOPX
Experimental
干预措施: Prednisone (Drug)
RCHOPX
Experimental
干预措施: Ibrutinib (Drug)
RCHOPX
Experimental
干预措施: Lenalidomide (Drug)
RCHOP
Active Comparator
干预措施: Rituximab (Drug)
RCHOP
Active Comparator
干预措施: Doxorubicin (Drug)
RCHOP
Active Comparator
干预措施: Cyclophosphamide (Drug)
RCHOPX
Experimental
干预措施: chidamide (Drug)
RCHOPX
Experimental
干预措施: decitabine (Drug)
结局指标
主要结局
complete response rate
时间窗: 21 days after 6 cycles of treatment (each cycle is 21 days)
次要结局
- progression free survival(2 year)
- overall survival(2 year)
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Up to 30 days after completion of study treatment)
- overall response rate(21 days after 6 cycles of treatment (each cycle is 21 days))
研究者
Zhao Weili
Deputy director of hematology department
Ruijin Hospital
研究点 (1)
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