NCT03364439已完成2 期
Prospective, Multicentre Phase II Study With R-CHOP- 14 or R-CHOP-21 & Consolidation PET-Oriented Radiotherapy (RT) in Diffuse Large B Cell Lymphoma (DLBCL) Patients With Low Risk Profile According to Age-adjusted IPI (0 With Bulky or 1)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 19
- 主要终点
- PFS Progression Free Survival
研究概览
简要总结
Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 & consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients
详细描述
Prospective, multicentre phase II study with R-CHOP- 14 or R-CHOP-21 & consolidation PET-oriented radiotherapy (RT) in diffuse large B cell lymphoma (DLBCL) patients with low risk profile according to age-adjusted IPI (0 with bulky or 1)
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of DLBCL (CD20+), follicular lymphoma grade IIIB, T-cell rich large B cell lymphoma
- •Age 18-80 years (patients >70 years old: FIT according to VGM evaluation).
- •aaIPI=1 +/- bulky and aaIPI=0 with bulky (>7.5 cm)
- •ECOG-PS < 3 unless due to lymphoma
- •Ventricular ejection fraction ≥ 50%
- •Pulmonary, renal and hepatic tests within normal range
- •Negative HIV and HBV tests. In case of HBcAb positive and HBsAb +/-, which is indicative of a past infection (occult carriers) the subject can be included, but antiviral prophylaxis with lamivudine must be given from the beginning of treatment until 12 months after treatment completion. Anti-HCV positive patients can be included in the absence of viral replication (HVR-RNA absent or less than 500 copies/ml.
- •Written informed consent
- •Life-expectancy > 3 months
排除标准
- •T-cell lymphoma
- •Follicular lymphoma (grade I, II, IIIA), marginal zone and mantle lymphoma
- •PS> 3 (if not due to lymphoma)
- •Age-adjusted IPI = 0 in the absence of bulky disease
- •Age> 80 and <18 years (see inclusion criteria)
- •HIV positivity
- •significant cardiopathy
研究组 & 干预措施
One arm for all patients
Experimental
Patients eligible for the study will receive 6 courses of R-CHOP14 or R-CHOP21.
干预措施: Treatment plan (Drug)
结局指标
主要结局
PFS Progression Free Survival
时间窗: 24 months
defined as non response after 4 or 6 cycles of chemotherapy or progression of disease after consolidation RT or at any time of therapy, relapse or death from any cause.
次要结局
- OS Overall Survival(48 months)
研究者
研究点 (19)
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