A Single Arm, Multi-center, Phase II Clinical Trial of VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- 2-year progression-free survival
研究概览
简要总结
This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of VR-CAP (Bortezomib and Rituximab-Cyclophosphamide, Epirubicin and Prednisone) in the first-line treatment for patients with marginal zone lymphoma.
详细描述
Marginal zone lymphoma (MZL) is a relatively common group of non-Hodgkin's lymphoma (NHL). The incidence rate is only inferior to diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL). Currently, NCCN guidelines recommend same treatment plan of FL like R-CHOP as the primary treatment for MZL. However, due to the great difference in cell origin and biological characteristics between FL and MZL, some patients can not achieve complete remission or relapse quickly after standard first-line treatment. A number of phase II clinical studies have evaluated the good efficacy of rituximab combined with chemotherapy in the treatment of MZL. Previous studies have shown that NF-κB signaling pathway is in abnormal activation state in MZL. Bortezomib, a proteasome inhibitor targeting NF-κB pathway, has a promising therapeutic prospect in relapsed and refractory MZL. The goal of our trial is to assess the efficacy and safety of VR-CAP (Bortezomib and Rituximab-Cyclophosphamide, Epirubicin and Prednisone) in the first-line treatment for patients with marginal zone lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 70 years old (including 18 and 70)
- •Diagnosed as marginal zone lymphoma
- •No receiving chemotherapy before enrollment
- •Indications for treatment: 1) symptoms related to tumor; 2) end-organ function damage; 3) large mass; 4) continuous or rapid progress of disease; 5) patient's willingness
- •Having at least one measurable lesions
- •World health organization-Eastern Cooperative Oncology Group Performance tatus (ECOG) 0-1
- •Life expectancy no less than 3 months
- •enough main organ function
- •Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
- •Agreeing to sign the written informed consents
排除标准
- •Diagnosed as central nervous system lymphoma
- •World health organization-Eastern Cooperative Oncology Group Performance tatus (ECOG) ≥2
- •Other malignant tumor history or active malignant tumor need be treated
- •Serious surgery and trauma less than two weeks
- •Systemic therapy for serious acute/chronic infection
- •Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
- •Active tuberculosis. Patients suspected of active TB need to be examined for chest X-ray, sputum and clinical symptoms and signs
- •HIV-positive, AIDS patients and untreated active hepatitis（HBV/HBV and HCV）
- •Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
- •Patients with a history of mental illness
- •Researchers determine unsuited to participate in this trial
研究组 & 干预措施
VR-CAP
Rituximab, 375 mg/m2, Intravenous administration on day 0, Bortezomib, 1.3 mg/m2 hypodermic injection on day 1 and 4, combined with regimen: Cyclophosphamide, Epirubicin, and Prednisone: repeated every 3 weeks, up to 6 cycles.
干预措施: Rituximab (Drug)
VR-CAP
Rituximab, 375 mg/m2, Intravenous administration on day 0, Bortezomib, 1.3 mg/m2 hypodermic injection on day 1 and 4, combined with regimen: Cyclophosphamide, Epirubicin, and Prednisone: repeated every 3 weeks, up to 6 cycles.
干预措施: Epirubicin (Drug)
VR-CAP
Rituximab, 375 mg/m2, Intravenous administration on day 0, Bortezomib, 1.3 mg/m2 hypodermic injection on day 1 and 4, combined with regimen: Cyclophosphamide, Epirubicin, and Prednisone: repeated every 3 weeks, up to 6 cycles.
干预措施: Bortezomib (Drug)
VR-CAP
Rituximab, 375 mg/m2, Intravenous administration on day 0, Bortezomib, 1.3 mg/m2 hypodermic injection on day 1 and 4, combined with regimen: Cyclophosphamide, Epirubicin, and Prednisone: repeated every 3 weeks, up to 6 cycles.
干预措施: Prednisone (Drug)
VR-CAP
Rituximab, 375 mg/m2, Intravenous administration on day 0, Bortezomib, 1.3 mg/m2 hypodermic injection on day 1 and 4, combined with regimen: Cyclophosphamide, Epirubicin, and Prednisone: repeated every 3 weeks, up to 6 cycles.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
2-year progression-free survival
时间窗: from the beginning day of the first cycle (each cycle is 21 days) of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment
the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first
次要结局
- objective response rate(every 6 weeks from the beginning day of the first cycle (each cycle is 21 days) of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment)
- incidence and relationship with study drugs of grade 3-4 adverse events(from the beginning day of the first cycle (each cycle is 21 days) of treatment to 6 months after last patient's enrollment)
- overall survival(from the beginning day of the first cycle (each cycle is 21 days) of treatment to the date of death from any cause, assessed up to 5 years)
研究者
Yanyan Liu
Director
Henan Cancer Hospital