Lenalidomide, Rituximab and Combination Chemotherapy Versus Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Highly Aggressive Non-Hodgkin B-cell Lymphoma
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Overall Response Rate after 6 cycles
研究概览
简要总结
In this study，lenalidomide was added in the first-line treatment in the newly diagnosed highly invasively non-Hodgkin B-cell lymphoma. The R2-CHOP/R2-EPOCH etc was applied compared with the classical R-CHOP/R-EPOCH etc. The investigators tried to explore a more effective and safe treatment regimen for patients with high-risk B-cell lymphoma to improve the patient's poor prognosis.
详细描述
Lymphoma has become one of the top ten malignant tumors, of which non-Hodgkin's B-cell lymphoma accounts for the majority. As the classic first-line treatment, the emergence of the R-CHOP program has resulted in clinical cures for more than 1/2 of patients with B-cell lymphoma. But for patients with highly aggressively B cell lymphoma, most of them still suffer from disease recurrences due to R-CHOP treatment alone.
In recent years, with the emergence of various new drugs, many researchers have tried to add new drugs to the classic R-CHOP program as a first-line treatment for non-Hodgkin B-cell lymphoma. As a new type of immunomodulator, lenalidomide was first approved for the treatment of multiple myeloma. In recent years, its role in refractory and relapsed B-cell lymphoma has gradually been recognized.
In 2015, Nowakowski et al. published a clinical study of 64 patients with diffuse large B-cell lymphoma who used R2-CHOP in first-line therapy. It was found that R2-CHOP does not improve R-CHOP in patients with GCB. The effective rate of treatment and the 2-year survival rate of patients, but for patients with non-GCB type DLBCL with poor prognosis, the addition of lenalidomide can greatly improve the remission rate of the disease and improve the poor prognosis of patients.
So, the investigators initiate this study to evaluate the efficacy of R2-CHOP/R2-EPOCH etc in newly diagnosed highly invasively non-Hodgkin 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
- Single (Participant)
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
- •Newly diagnosed highly aggressively B-Cell Non-Hodgkin's lymphoma (NHL) confirmed by histopathology
- •The patient has at least ≥1 measurable tumor lesion with a diameter >1.5 cm;
- •The patient has not undergone systemic chemotherapy or immunotherapy before;
- •ECOG score ≤ 2 points;
- •Liver and kidney function meets the following conditions: creatinine clearance rate ≥ 30ml / min, total bilirubin, AST and ALT ≤ 2.5 × ULN;
- •No history of malignant tumors within 5 years, except for cured carcinomas in situ such as basal cell carcinoma of the skin, cervical cancer, breast cancer, prostate cancer, etc.;
- •agree to take contraceptive measures during the trial period and within 3 months after the end of the trial;
- •Patients volunteered to participate in the study and signed informed consent.
排除标准
- •Serious cardiovascular and other important organs and blood, endocrine system lesions, and other history of malignant tumors;
- •Severe mental illness;
- •Pregnant or lactating women and men or women who intend to conceive in the near future;
- •The expected survival time is less than 6 months;
- •HBV, HCV or HIV infection or seropositive;
- •there are active infections;
- •Allergies or allergies to rituximab;
- •Compliance or poor follow-up;
- •Other circumstances that the investigator believes are not suitable for inclusion.
研究组 & 干预措施
R2-combination chemotherapy
R2-CHOP/CHOPE/DA-EPOCH/HD MTX
R2-CHOP :
lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5
R2-DA-EPOCH:
lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5;
R2-HD MTX:
lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1
干预措施: R2-combination chemotherapy (Drug)
R-combination chemotherapy
R-CHOP/CHOPE/DA-EPOCH/HD MTX
R-CHOP :
Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5
R-DA-EPOCH:
Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5;
R-HD MTX:
Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1
干预措施: R-combination chemotherapy (Drug)
结局指标
主要结局
Overall Response Rate after 6 cycles
时间窗: at the end of 6 cycles( each cycle is 21 days)
Percentage of patients with complete remission （CR）or partial remission （PR）
Overall Response Rate after 3 cycles
时间窗: at the end of 3 cycles( each cycle is 21 days)
Percentage of patients with complete remission （CR）or partial remission （PR）
次要结局
- Progression free survival（PFS）(2 years)
- overall survival（OS）(2 years)
研究者
Wang Xin
Director of Hematology Department
Shandong Provincial Hospital