Phase III Multicentric IIL Study, Three Randomized Arms (R-CVP vs R-CHOP vs R-FM),for Treatment of Patients With Stage II-IV Follicular Lymphoma
试验速览
- 阶段
- 3 期
- 入组人数
- 534
- 试验地点
- 82
- 主要终点
- Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM.
研究概览
简要总结
The purpose of this study is to define an improvement and theassessment of the Time to Treatment Failure in patients randomized in three different arms:
R-CVP vs R-CHOP vs R-FM.
详细描述
Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP - Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM. - Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological DIAGNOSIS of B cell follicular lymphoma
- •ECOG performance status 0-2
- •Age range 18-75
- •Ann Arbor Stage: II-IV
- •Assessment of pathology with diagnostics biopsy
- •Presence of one of these criteria:
- •B Sistemic symptoms B
- •Extranodale pathology
- •Cytopenia
- •Splenomegaly
- •Serous effusion
- •Ves > 20 mm/h
- •Ldh > normal value
- •Nodale or extranodal mass > 7 cm
- •3 or more nodal sites > 3 cm
- •Adenopatic syndrome
- •LVEF > 50%
- •Normal hepatic (bilirubin < 1.5 mg/dl) and renal functionality (creatinin < 2 mg/dl). If there is a lymphoma it's allow values of bilirubin > 1.5 mg/dl and of creatinin > 2mg/dl
- •No previous treatment for follicolar lymphoma unless RT-IF
- •Lifetime > 6 mounth
- •Absence of HbsAg, HCV e HIV
- •Negative Coombs Test
- •Negative pregnant test
- •Cotracceptive method during the treatment and the follow three months
- •Formal written consent
- •Ability to follow the patients after the treatment for follow up
排除标准
- •Histological Diagnosis of all type of lymphoma unless Follicularlymphoma, CD20 lymphoma, stage IIIb of follicular lymphoma and high degree lymphoma
- •Stage I of Ann Arbor scale
- •Central Nervous system involvement
- •HIV, HBV OR HCV Positivity
- •Cardiac Pathology
- •Positive Coombs Test
- •Previous chemotherapeutic treatment
- •Hypersensitivity to antibodyes or other murine proteins
- •Previous cancer pathology unless in situ cervix and epithelial carcinomas
- •Other type of infections
- •Pregnant and nursing woman
研究组 & 干预措施
1
R-CVP x 3; Restaging if> RP then R-CVP x 5
干预措施: R-CVP (Drug)
2
R-CHOP x 3; Restaging if > RP then R-CHOP x 3 plus 2 Rituximab
干预措施: R-CHOP (Drug)
3
R-FM x 3; Restaging if > RP then R-FM x 3 plus 2 Rituximab
干预措施: R-FM (Drug)
结局指标
主要结局
Assessment of the Time to Treatment Failure (TTF)in patients treated with R-CVP, R-CHOP and R-FM.
时间窗: 2 years
次要结局
- Assessment of Overall Survival (OS)in patients treated with R-CVP, R-CHOP and R-FM. -(3 years)
- Assessment of Progression Free Survival (PFS)in patients treated with R-CVP, R-CHOP(2 years)
- Assessment of Duration of Response (DR)in patients treated with R-CVP, R-CHOP and R-FM.(2 years)
- Assessment of Response Rate(RR) in patients treated with R-CVP, R-CHOP and R-FM.(2 years)
- Assessment of molecular Response Rate in patients treated with R-CVP, R-CHOP and R-FM.(2 years)
- Assessment of toxicity of R-CVP, R-CHOP, R-FM treatments.(2 years)