EUCTR2010-019248-37-IT进行中（未招募）不适用
A Phase II study of Bendamustine in Combination With Rituximab as Initial Treatment for Patients With Indolent non-follicular Non-Hodgkin’s Lymphoma
FONDAZIONE ITALIANA LINFOMI ONLUS0 个研究点开始时间: 2012年3月20日最近更新:
适应症
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) Understand and voluntarily sign an informed consent form 2) Histological (bone marrow or lymph nodes biopsy) proven diagnosis of B-cell CD20- positive non-follicular NHL according to REAL/WHO Classification: i. small lymphocytic lymphoma-SLL (bone marrow or lymph nodes biopsy) ii. lymphoplasmacytic/citoid lymphoma/ Waldenstrom macroglobulinemia (bone marrow or lymph nodes biopsy) iii. nodal marginal zone lymphoma (lymph nodes biopsy) 3) Untreated patients 4) Stage III or IV or stage II with more than three involved sites 5) Presence of at least one of the following criteria for the definition of active disease a. Systemic symptoms b. Hemoglobin less than 10 g/dL (due to lymphoma) c. Platelets less than 100 x 109/L (due to lymphoma) d. Diffuse bone marrow infiltrate e. Lymphocyte doubling time less than 12 months (in leukemic cases) f. Bulky disease (>7 cm) 6) Aged 18 - 75 Life expectancy >6 months 7) ECOG performance status 0-2 8) LVEF =45% or FS =37% 9) ANC =1 x 109/l and Platelets count =75 x 109/l, unless due to bone marrow involvement by follicular lymphoma 10) Creatinine up to 1.5 x ULN 11) Conjugated bilirubin up to 2 x ULN 12) Alkaline phosphatase and transaminases up to 2 x ULN 13) Written informed content
- •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. Patients with diagnosis of marginal zone lymphoma of splenic or MALT origin 2. Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL) 3. Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy 4. History of other malignancies within 3 years prior to study entry except for: adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage, localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent 5. Medical condition requiring long term use (>1 months) of systemic corticosteroids 6. Active bacterial, viral, or fungal infection requiring systemic therapy 7. Concurrent medical condition which might exclude administration of therapy 8. Cardiac insufficiency (NYHA grade III/IV) 9. Myocardial infarction within 6 months of entry on study 10. Severe chronic obstructive pulmonary disease with hypoxemia 11. Severe diabetes mellitus difficult to control with adequate insulin therapy 12. Hypertension that is difficult to control 13. Impaired renal function with creatinine clearance <30 ml/min 14. HIV positivity 15. HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive (these patientes need to receive prophylaxis with Lamivudine) 16. HCV positivity with the exception of patients with HCV RNA negative. 17. CNS involvement by lymphoma 18. Participation at the same time in another study in with investiogational drugs are used 19. Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins 20. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent 21. Women in pregnancy or breastfeeding
研究者
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