EUCTR2005-005406-24-IT进行中（未招募）不适用
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
FONDAZIONE ITALIANA LINFOMI ONLUS0 个研究点开始时间: 2007年3月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Histological DIAGNOSIS of B cell FOLLICULAR LYMPHOMA 2. ECOG performance status 0-2 3. Age range 18-75 4. Ann Arbor Stage: II-IV 5. assessment of pathology with diagnostics biopsy 6. Presence of one of these criteria: a)B Sistemic symptoms B b)extranodale pathology c)cytopenia d)splenomegaly e)leukemia f)SEROUS EFFUSION g)ves>20 mm/h h)ldh >normal value i)nodale or extranodal mass > 7 cm j)3 or more nodal sites >3 cm k)adenopatic syndrome 7.LVEF> 50% 8.Normal hepatic (bilirubin <1.5 mg/dl) and renal functionality (creatinin < 2mg/dl). If there is a lymphoma it's allow values of bilirubin >1.5 mg/dl and of creatinin > 2mg/dl. 9.No previous treatment for follicolar lymphoma unless RT-IF 10.lifetime > 6 mounth 11.Absence of HbsAg, HCV e HIV. 12.negative Coombs Test 13.negative pregnant test 14.cotracceptive method during the treatment and the follow three months. 15. formal written consent 16.Ability to follow the patients after the treatment for follow up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Histological Diagnosis of all type of lymphoma unless Follicular lymphoma, CD20 lymphoma, stage IIIb of follicular lymphoma and high degree lymphoma 2. Stage I of Ann Arbor scale 3. central Nervous system involvement 4. HIV,HBV OR HCV Positivity 5. Cardiac Pathology 6. Positive Coombs Test 7. Previous chemotherapeutic treatment 8. Hypersensitivity to antibodyes or other murine proteins 9. Previous cancer pathology unless in situ cervix and epithelial carcinomas 10. other type of infections 11. Pregnant and nursing woman
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