First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance.A Multicentre, Phase III Randomized Study by the PLRG.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 12
- 主要终点
- Event Free Survival
研究概览
简要总结
Evaluation of event free survival (EFS) of patients treated with the study chemotherapy induction program: R-CHOP compared to the standard R-CVP regimen and response rates, time to best response, PFS, OS, neutropenic fever rate, infection rate, change in Ig levels, change in lymphocyte subpopulations counts in previously untreated indolent lymphoma patients in need of systemic treatment.
详细描述
Min. 3, max. 8 induction cycles. Maintenance with rituximab q. 2 months x 12/24 months, started 2 months after last chemotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed:
- •Follicular lymphoma grade 1, 2, 3a
- •Marginal zone lymphoma, including MALT type
- •Small lymphocytic lymphoma (BM inv. < 30%)
- •Lymphoplasmacytic lymphoma
- •Clinical stage II-IV (Ann Arbor). Stage I is allowed if bulky (Ø > 7 cm) or if radiotherapy is not appropriate in judgment of treating physician
- •Measurable lesion(s) in at least one site
- •Patients previously untreated
- •Patients presenting with symptoms requiring treatment:
- •Progressive disease
- •Symptoms related to tumor bulk
- •Cytopenias related to bone marrow and/or spleen involvement B symptoms
- •Age ≥ 18 years
- •Performance status </=2
- •Written informed consent
排除标准
- •Grade 3b FL
- •Transformed lymphoma
- •CNS involvement
- •Patient taking steroids for > 2 weeks during last 4 weeks at a dose equivalent to ≥ 20 mg prednisone
- •Other malignancy
- •Major surgery within 4 weeks
- •Hb < 8 g/dl, ANC < 1.5 x 109/L, Plt <100 109/L unless due to lymphoma
- •Impairment of renal function (creatinine > 1.5 x UNV) or liver function (total bilirubin 1.5 x UNV, SGOT > 2.5 x UNV not due to lymphoma
- •Known infection, with HBV, HCV (acute < 6 mos. or chronic hepatitis) or HIV
- •Serious underlying medical conditions
- •Life expectancy < 6 months
- •Known allergy to murine protein
研究组 & 干预措施
R-CVP
Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
干预措施: Vincristine (Drug)
R-CVP
Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
干预措施: Prednisone 2 (Drug)
R-CVP
Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
干预措施: Rituximab (Drug)
R-CVP
Standard arm 1. R-CVP - Rituximab, Cyclophosphamide, Vincristine, Prednisone 2
干预措施: Cyclophosphamide (Drug)
R-CHOP
Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
干预措施: Rituximab (Drug)
R-CHOP
Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
干预措施: Cyclophosphamide (Drug)
R-CHOP
Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
干预措施: Doxorubicin (Drug)
R-CHOP
Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
干预措施: Vincristine (Drug)
R-CHOP
Study arm 2. R-CHOP - Rituximab, Cyclophosphamide, Hydroxyldaunorubicine (doxorubicin), Oncovin (vincristine), Prednisone 1
干预措施: Prednisone 1 (Drug)
结局指标
主要结局
Event Free Survival
时间窗: +3 yrs
次要结局
- Response Rate(+2 yrs)