EUCTR2009-012337-29-IT进行中（未招募）不适用
Brief induction chemoimmunotherapy with Rituximab + Bendamustine + Mitoxantrone followed by Rituximab in elderly patients with advanced stage previously untreated follicular lymphoma - IILFLE09
FONDAZIONE ITALIANA LINFOMI ONLUS0 个研究点开始时间: 2012年1月9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 proven diagnosis of B-cell CD20+ follicular NHL, grade I, II and IIIa of WHO Classification 2. Untreated patients with the exception of prior limited radiotherapy 3. Stage III or IV who require therapy according to SIE and GELF criteria (see Appendix A) 4. Stage II with at least one of the following: a. Bulky disease (>7 cm) b. LDH >normal c. Systemic symptoms d. Beta2-Microglobulin >3 mg/l e. Extra-nodal involvement f. Active disease with rapid progression 5. Age from 65 to 80 years, geriatric score ?FIT? (see Appendix B) 6. Life expectancy >6 months 7. ECOG performance status 0-2 (see Appendix C) 8. LVEF ≥45% or FS ≥37% 9. ANC ≥1 x 10^9/l and Platelets count ≥75 x 10^9/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. Sending of bone marrow sample for Bcl-2/IgH rearrangement evaluation 14. 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) no
- •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. Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy 2. 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 3. Medical condition requiring long term use (>1 months) of systemic corticosteroids 4. Active bacterial, viral, or fungal infection requiring systemic therapy 5. Concurrent medical condition which might exclude administration of therapy 6. Cardiac insufficiency (NYHA grade III/IV; see Appendix D) 7. Myocardial infarction within 6 months of entry on study 8. Severe chronic obstructive pulmonary disease with hypoxemia 9. Severe diabetes mellitus difficult to control with adequate insulin therapy 10. Hypertension that is difficult to control 11. Impaired renal function with creatinine clearance <30 ml/min (see Appendix E) 12. HIV positivity 13. HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive (these patients need to receive prophylaxis with Lamivudine) 14. HCV positivity with the exception of patients with no laboratory signs of active chronic hepatitis and HCV-RNA negativity 15. CNS involvement by lymphoma 16. Participation at the same time in another study in which investigational drugs are used 17. Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins 18. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
研究者
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