The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Progression of disease within 24 months
研究概览
简要总结
The Safety and Effectiveness of Four Courses of R-CHOP Plus Four Courses of Rituximab Versus Six Courses of R-CHOP Plus Two Courses of Rituximab in the Treatment of Naive, Low-risk, Non-mass Diffuse Large B-cell Lymphoma: a Multi-center, Prospective, Randomized Controlled Study
详细描述
Diffuse large B cell lymphoma (DLBCL) is the subtype with the highest incidence, accounting for 35.8% of B cell lymphoma. 6 to 8 cycles of R-CHOP regimen is currently the standard first-line regimen for DLBCL, however, the side effects including nausea, vomiting, neutropenia, hair loss, and heart failure can decrease the life quality and are sometimes life threatening. Recently, domestic and foreign scholars have been committed to reduce the dose of chemotherapy and improve the quality of life in low-risk patients. This study uses 4 courses of R-CHOP plus 4 courses of R (4+4 plan) versus 6 courses of R-CHOP plus 2 courses of R (6+2 plan) for the treatment of newly treated, low-risk, non-mass DLBCL patients. The promising result will create a new model for the treatment and improve the life quality of low-risk DLBCL.
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
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed CD20 positive DLBCL based on 2016 WHO classification who achieved CR after 4 cycles of RCHOP therapy (examined by PET-CT, Deauville score 1-2)
- •Treatment naïve
- •Age ≥ 14 or ≤75 years
- •non-mass (The length of the lesion<7.5cm)
- •Life expectancy>6 months
- •Informed consented
排除标准
- •Have received systemic or local treatment including chemotherapy in the past
- •Have received autologous stem cell transplantation in the past
- •Past medical history of other malignant tumors, except basal cell carcinoma of the skin and cervical cancer in situ
- •Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases, severe infectious diseases and other diseases
- •Primary skin, primary central nervous system lymphoma
- •Left ventricular ejection fraction ≦50%
- •Other concurrent and uncontrolled situation which will affect the patient's medical status based on researchers decision
- •Laboratory test value during screening: (unless it is caused by lymphoma) Neutrophils <1.5*109/L Platelet<80*109/L Hemoglobin <100g/L ALT or AST is 2 times higher than the upper limit of normal, AKP and bilirubin are 1.5 times higher than the upper limit of normal E. Creatinine level is higher than 1.5 times the upper limit of normal
- •Psychiatric patients or other patients who are known or suspected to be unable to fully accomplish with the research protocol
- •Pregnant or lactating women
- •Patients with positive HbsAg test results need to undergo HBV-DNA test and can be admitted to the group after turning negative. In addition, if the HBsAg test result is negative, but the HBcAb test is positive (regardless of the HBsAb status), HBV-DNA is also required；if the result is positive, patients also need to be treated to become negative before entering the group
- •Patients living with HIV
- •Patients with TP53 mutations or those who have not undergone DLBCL hot spot gene screening
研究组 & 干预措施
4RCHOP+4R
Four Courses of R-CHOP Plus Four Courses of Rituximab
干预措施: Four Courses of R-CHOP Plus Four Courses of Rituximab (Drug)
6RCHOP+2R
Six Courses of R-CHOP Plus Two Courses of Rituximab
干预措施: Six Courses of R-CHOP Plus Two Courses of Rituximab (Drug)
结局指标
主要结局
Progression of disease within 24 months
时间窗: Baseline up to data cut-off (up to approximately 24 months)
Progression of disease within 24 months was defined as the rate of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
次要结局
- Overall survival(Baseline up to data cut-off (up to approximately 2 years))
- Overall response rate(t the end of Cycle 8 (each cycle is 21 days))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Up to 30 days after completion of study treatment)
- Quality of life of patients(Up to 30 days after completion of study treatment)
研究者
Zhao Weili
First Deputy Director, Hematology Department
Ruijin Hospital