EUCTR2008-001591-80-IT进行中（未招募）1 期
PHASE II STUDY OF LENALIDOMIDE IN COMBINATION WITH RITUXIMAB (R) FOR THE TREATMENT OF INDOLENT NON FOLLICULAR NON HODGKIN LYMPHOMA - ND
G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI0 个研究点开始时间: 2009年1月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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 proved diagnosis of B-cell CD20-positive non follicular NHL according to REAL/WHO Classification: a. small lymphocytic lymphoma b. lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia, c. nodal marginal zone lymphoma d. splenic marginal zone lymphomae e. extranodal non-gastric marginal zone lymphoma Tissue biopsy is mandatory when suspected pathological sites (nodal or extranodal) are easily accessible and in presence of extranodal non-gastric marginal or nodal marginal zone lymphoma diagnosis. In the other cases bone marrow biopsy, when representative, may be considered sufficient for defining lymphoma histotype. 2) Disease relapsing after >2, but less than 4 prior lines of (immuno)chemotherapy. At least one of previous treatment had to include rituximab 3) Presence of at least one of the following criteria for the definition of active disease: - systemic symptoms - bulky disease - progressive marrow failure and/or splenomegaly and/or lymph adenopathy 4) Age 18-75; 5) Life expectancy > 6 months; 6) ECOG performance status 0-2; 7) LVEF ³ 45%; 8) Creatinine clearance > 50 mL/min calculated by Cockcroft-Gault estimation; patients with creatinine clearance > 30 and < 50 mL/min, at physician discretion could enter in the study starting at lenalidomide dose level -2 (10 mg ); 9) Total bilirubin up to 2 x ULN. Total bilirubin values higher than 2 x ULN are admitted if related to localization of the disease; 10) Alkaline phosphatase up to 2 x ULN and transaminases up to 3 x ULN; 11) Female and male patients must agree to participate in pregnancy prevention program signed informed Consent 12) Written informed Consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •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) Previously untreated patients; 2) Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL); 3) Women and men not agreeing to take adequate contraceptive precautions during and for at least 4 weeks after cessation of therapy; 4) Pregnant or lactating women; 5) History of other malignancies within 3 years prior to study entry except for adequately treated carcinoma in situ of the cervix or 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; 6) Active bacterial, viral or fungal infection requiring systemic therapy; 7) Concurrent co-morbid medical condition which might exclude administration of therapy; 8) Cardiac insufficiency (NYHA grade III/IV); 9)Myocardial infarction within 6 months of entry on the 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) Creatinine clearance < 30 mL/min calculated by Cockcroft-Gault estimation; 14)ANC < 1 x 109/L, unless due to lymphoma involvement and not responding to 5 days of G-CFS treatment. 15)Platelets count < 75.000/mm3 unless due to lymphoma involvement 16) HIV and HBV positivity
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