A Multicenter,Randomized, Controlled (Comparative), Open, Prospective Study Evaluating an Efficacy of R-DA-EPOCH and R-CEOP90, With or Without Upfront Auto-HSCT，in Newly Diagnosed Young Patients With High-risk DLBCL
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 475
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
Patients initially are randomized into 2 arms:
Arm I: R-DA-EPOCH; Arm II: R-CEOP90;
Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of R-DA-EPOCH (Arm I) or R-CEOP90 (Arm II), continue to have 2 more cycles for consolidation in each arm, or undergo stem cell harvest and auto-HSCT following standard institutional protocols.
详细描述
Patients initially are randomized into 2 arms:
Arm I: R-DA-EPOCH; Arm II: R-CEOP90;
Patients who achieved complete remission (CR) or partial remission (PR) after 6 cycles of R-DA-EPOCH (Arm I) or R-CEOP90 (Arm II), continue to have 2 more cycles for consolidation in each arm, or undergo stem cell harvest and auto-HSCT following standard institutional protocols.
The overall purpose of the study is to determine if R-CEOP90 followed by auto-HSCT has similar efficacy compared to that with R-DA-EPOCH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16-60 years
- •Newly diagnosed DLBCL
- •No previous treatment with chemotherapy and/or radiation therapy of DLBCL
- •Presence of 2 or more signs of unfavorable prognosis: aaIPI≥2 or aaIPI=1 with Bulk (≥7.5cm)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Life expectancy of ≥6 months
- •Adequate hematological function
- •Offer informed consent
排除标准
- •Transformation of mature cell lymphomas in DLBCL
- •Pretreated DLBCL
- •HIV-associated DLBCL
- •Concomitant other cancer
- •Congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction
- •Renal insufficiency (serum creatinine greater than 0.2 mmol/L) (except cases with specific kidney infiltration, urinary tract compression by tumor conglomerate or presence of uric acid nephropathy due to massive cytolysis syndrome)
- •Liver failure (except cases with liver tumor infiltration), acute hepatitis or active phase of chronic hepatitis B or C with serum bilirubin greater than 1.5 standards, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3 standards, prothrombin index less than 70%
- •Severe pneumonia (except cases with specific lungs infiltration), accompanied by respiratory failure (dyspnea > 30 in min., hypoxemia less than 70 mm Hg, when it is impossible to compensate situation in 2-3 days)
- •Life-threatening bleeding (gastrointestinal, intracranial), with exception of bleeding due to tumor infiltration of organs (stomach, intestines, uterus, etc.) and disseminated intravascular coagulation due to underlying disease complications after their successful conservative treatment
- •Severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related with specific infiltration of central nervous system
- •Decompensated diabetes
- •Pregnancy
研究组 & 干预措施
Arm I:R-DA-EPOCH
Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles.
干预措施: R-DA-EPOCH (Drug)
Arm II:R-CEOP90
Protocol involves 6 cycles. Patients with complete remission or partial remission undergo auto-HSCT after 6 cycles.
干预措施: R-CEOP90 (Drug)
结局指标
主要结局
progression-free survival
时间窗: Two-year survival
Time to disease progression is calculated in months from day of enrollment in the study until disease progression, as appropriate
次要结局
- complete response(6 cycles)
- overall survival(Two-year survival)
- Incidence of Treatment-Emergent Adverse Events(During the treatment)
研究者
Jianda Hu
Prof.
Fujian Medical University