EUCTR2009-011277-33-DE进行中（未招募）不适用
A therapy and pharmacokinetics study of temsirolimus in patients with refractory and recidivated primary CNS lymphoma - Temsirolimus in PZNS
Charité - University Hospital of Berlin0 个研究点开始时间: 2009年5月26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
- •- Primary CNS lymphoma diagnosed histologically or by cerebrospinal fluid cytology; absence of systemic lymphoma manifestaions
- •- Relapse or lymphoma progression after/during high-dose methotrexate containing first-line chemotherapy or alternative therapy in the case of contraindications against high-dose methotrexate
- •- ECOG performance score = 2
- •- Age =18 and = 75 years
- •- Life expectancy of at least 3 months
- •- Absence of active infection
- •- Negative HIV serology
- •- Adequate renal function (GFR >30ml/min)
- •- Adequate bone marrow resere (neutrophils > 1500/µl, platelets > 80,000/µl)
- •- Bilirubin <1.5x upper limit of normal (ULN), ALT and AST <3x ULN
- •- At least 3 weeks interval from prior cytostatic treatment
- •- Negative pregnancy test
- •- Patient accessible for treatment and follow-up
- •- Patient compliance
- •- Signed written informed consent (AMG §40 (1) 3b)
- •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
- •- Primary CNS lymphoma diagnosed histologically or by cerebrospinal fluid cytology; absence of systemic lymphoma manifestaions
- •- Relapse or lymphoma progression after/during high-dose methotrexate containing first-line chemotherapy or alternative therapy in the case of contraindications against high-dose methotrexate
- •- ECOG performance score = 2
- •- Age =18 and = 75 years
- •- Life expectancy of at least 3 months
- •- Absence of active infection
- •- Negative HIV serology
- •- Adequate renal function (GFR >30ml/min)
- •- Adequate bone marrow resere (neutrophils > 1500/µl, platelets > 80,000/µl)
- •- Bilirubin <1.5x upper limit of normal (ULN), ALT and AST <3x ULN
- •- At least 3 weeks interval from prior cytostatic treatment
- •- Negative pregnancy test
- •- Patient accessible for treatment and follow-up
- •- Patient compliance
- •- Signed written informed consent (AMG §40 (1) 3b)
- •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
- •- Secundary CNS lymphoma
- •- Primary intraocular lymphoma
- •- Concurrent treatment within another clinical trial
- •- Patients who are suitable for high-dose chemotherapy with autologous stem cell transplantation
- •- Concurrent other malignant disease
- •- Symptomatic congestive heart failure (=NYHA II)
- •- Active or uncontrolled chronic infection
- •- Severe concomitant disease incompatible with study conduct
- •- History of cerebral bleeding
- •- Concomitant treatment with strong CYP3A4/5-inductors or –inhibitors
- •- Premenopausal women without highly effective contraception (defined as Pearl index <1)
- •- Pregnant or lactating women
- •- Refusal to record and pass on pseudonymized disease and treatment related data as part of the treatment protocol
- •- Subjects who are legally detained in an official institute
- •- Secundary CNS lymphoma
- •- Primary intraocular lymphoma
- •- Concurrent treatment within another clinical trial
- •- Patients who are suitable for high-dose chemotherapy with autologous stem cell transplantation
- •- Concurrent other malignant disease
- •- Symptomatic congestive heart failure (=NYHA II)
- •- Active or uncontrolled chronic infection
- •- Severe concomitant disease incompatible with study conduct
- •- History of cerebral bleeding
- •- Concomitant treatment with strong CYP3A4/5-inductors or –inhibitors
- •- Premenopausal women without highly effective contraception (defined as Pearl index <1)
- •- Pregnant or lactating women
- •- Refusal to record and pass on pseudonymized disease and treatment related data as part of the treatment protocol
- •- Subjects who are legally detained in an official institute
研究者
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