EUCTR2012-003786-17-FR进行中（未招募）1 期
Phase II study evaluating the efficacy of Lenalidomide in association with Rituximab in refractory or relapse of primary central nervous system lymphoma (PCNSL) - Proof of concept” - REVRI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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. Patients over 18 years old with a refractory or relapse PCNSL and who have previously received at least high dose methotrexate (> 1.5 g/m²) and high dose cytarabine (2 g/m²).
- •2. Patients can have received radiotherapy or intensive chemotherapy with hematopoietic stem cell rescue as part of treatment of the PCNSL or IOL
- •3. Patients over 18 years old with a refractory or relapse IOL and who have received either intravenous high dose methotrexate (> 1.5 g/m2) or intraocular methotrexate
- •4. Life expectancy > 2 months
- •5. Able to swallow capsules (stomach tube not allowed)
- •6. Adequate bone marrow function with absolute leukocytes > 2000/mm3, neutrophil count (ANC) > 1000/mm3, haemoglobin > 8 g/dl and platelets > 100 000/mm3
- •7. Calculated creatinine clearance > 40 ml/min. Patients with calculated creatinine clearance between 40 and 50ml/min lenalidomide dose will be adjusted as follows (10mg once daily)
- •8. Patient aged 18 years old or more and without measure of legal protection
- •9. Able to understand teratogenic risks of the treatment
- •10. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study and for at least 4 weeks after discontinuation of all study treatments The pregnancy test (ßHCG amount) must be negative at the inclusion and during the study. Men must agree not to procreate a child and use condoms if their partner can procreate, during all the treatment period.
- •11. Signed inform 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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1.Contraindication to any drug contained in the chemotherapy regimen or to any of their excipients
- •2.T-cell lymphoma
- •3.Diagnosis of any second malignancy within the last 5 years
- •4.Prior history of organ transplantation or other cause of severe immunodeficiency
- •5.Known HIV or HTLV-1 infection, positive serology to HB surface antigen [HBsAg] or total HB core antibody [anti-HB-c]) and Hepatitis C (Hepatitis C virus [HCV] antibody)
- •6.Inclusion in another experimental anti-cancer drug therapy
- •7.Impossibility to follow the calendar of exams because of geographic, social or psychological reasons
- •8.Patient under guardianship
- •9.No social security
研究者
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