EUCTR2008-003729-18-IT进行中（未招募）1 期
A phase II trial to evaluate the safety and activity of single-agent lenalidomide given as maintenance therapy after response to second-line therapy in patients with relapsed diffuse large B cell lymphoma, not eligible for high-dose chemotherapy and autologous transplantation [Lenalidomide and DLBCL - ND
OSPEDALE S. RAFFAELE0 个研究点目标入组 38 人开始时间: 2008年6月13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
- 入组人数
- 38
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
- •- Age 65 years or younger but not eligible to high-dose chemotherapy and autologous stem cell transplantation - biopsy-proven DLBCL relapsed to previous combination chemotherapy regimen ± rituximab - PR or CR to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab - ECOG performance status score 3 - Female of childbearing potential (FCBP) must demonstrate to practice a proper contraception to avoid any pregnancy risk during the study and at least 28 days after the discontinuation of the study - Male subjects must agree to practice a proper contraception during any sexual contact with females childbearing potential
- •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
- •- CNS involvement - Prior ASCT - TTP <6 months after first-line therapy - Use of experimental drugs during second-line salvage chemotherapy - Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus ) - Active infectious disease - HIV, HBV or HCV- positivity - Impaired liver function (Bilirubin >2 x upper normal limit; ALT/AST/GGT > 3 x upper normal limit) at one month from salvage chemotherapy conclusion - Impaired renal function (creatinine clearance <50 ml/min) at one month from salvage chemotherapy conclusion - Absolute neutrophil count (ANC) <1000/L - Platelet count <75.000 /mm3 - Hemoglobin <9 g/dL - Non-co-operative behaviour or non-compliance - Psychiatric diseases or conditions that might impair the ability to give informed consent - Pregnant or lactating females
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