跳至主要内容
临床试验/EUCTR2007-003560-21-IT
EUCTR2007-003560-21-IT进行中(未招募)不适用

Prospective multicenter phase I-II pilot trial to evaluate efficacy and safety of treatment with Lenalidomide plus R-CHOP21 (LR-CHOP21) for elderly patients with untreated Diffuse Large B-Cell Lymphoma (DLBCL). - REAL07

GIMURE0 个研究点开始时间: 2007年10月5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. Histologic subtypes as follows: a. CD20 positive Diffuse large B-Cell lymphoma b. CD20 positive Follicular grade IIIb 2. Age 60-80 3. Measurable and/or evaluable disease. 4. Ann Arbor stage II, III, IV 5. International Prognostic Index at low-intermediate, intermediate, high risk (2/3/4-5) 5. Adequate haematological counts: ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement 6. Conjugated bilirubin up to 2 x ULN. 7. Alkaline phosphatase and transaminases up to 2 x ULN.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • 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. Lymphoblastic Lymphoma 2. Burkitt Lymphoma 3. Non Hodgkin lymphoma CD 20 negative 4. Mantle Cell Lymphoma 5. Follicular Non Hodgkin Lymphoma grade I-II-IIIa 6. Primitive mediastinal diffuse large B cell lymphoma with only mediastinal involvement 7. International Prognostic Index at low risk (1) 8. Has known or suspected hypersensitivity or intolerance to rituximab 9. History of evolutive malignancy within the last 3 years other than squamous cell and basal cell carcinoma.

研究者

发起方
GIMURE

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