EUCTR2009-011225-14-IT进行中（未招募）不适用
A PROSPECTIVE, MULTICENTER PHASE II STUDY EVALUATING PREDICTIVE FACTORS FOR LENALIDOMIDE TREATMENT RESPONSE IN RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS. - Le.P.Re study
AZIENDA OSPEDALIERA POLICLINICO DI MODENA0 个研究点开始时间: 2009年4月23日最近更新:
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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
- •Patients must understand and voluntarily sign an informed consent form.
- •Must be ≥ 18 years at the time of signing the informed consent form.
- •Must be able to adhere to the study visit schedule and other protocol requirements.
- •Must have a documented diagnosis of B-cell CLL (IWCLL guidelines for the diagnosis and treatment of chronic lymphocytic leukemia, [Hallek M et al, 2008]).
- •Rai stage III or IV disease or requiring treatment for Rai stage I or II disease as defined in the Updated National Cancer Institute (NCI) guidelines (Hallek M et al, 2008). See Appendix B.
- •Patients must have received at least a purine-analogue containing regimen and have experienced relapse or have been refractory to the last therapy. Patients must not have received any therapy for B-CLL in the 4 weeks before this study or Alemtuzumab in the 6 months before initiating the treatment of this study.
- •Eastern Cooperative Oncology Group performance status of ≤ 2.
- •Absolute neutrophil count ≥ 2.000/μL
- •Platelet count ≥ 75/μL
- •Calculated creatinine clearance > 60 mL/min and creatinine < 1,5 mg/dl.
- •Total bilirubin < 2 mg/dl ( or > 2 mg/dl if Gilbert ?s Sindrome).
- •ALT and AST < 3x upper normal limit.
- •Female patients of Child-Bearing Potential (FCBP) must have 2 negative medically supervised pregnancy tests prior to starting the drug. They must agree to ongoing pregnancy testing during the course of the study, and after the end of the study therapy. They must adopt reliable methods of contraception and avoid becoming pregnant for at least 28 days after the discontinuation of the study drug.
- •Male patients must agree to use latex condoms during sexual contacts with female of child-bearing potential even if they have had a vasectomy, throughout study drug therapy, during any drug interruption and after cessation of study therapy. They must agree not to donate blood or semen for up to 28 days after study drug discontinuation.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any serious medical condition, laboratory anormality or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Active infections requiring systemic antibiotics.
- •Known positive for HIV or active infectious hepatitis.
- •Active bacterial, viral, or fungal infection requiring systemic anti-viral, antibiotic or antifungal therapy.
- •Autologous or allogenic bone marrow transplant as second line therapy.
- •Pregnant or lactating females.
- •Patients must not have received any therapy for B-CLL in the 4 weeks before or Alemtuzumab 6 months before initiating the treatment of this study.
- •History of renal failure requiring dialysis.
- •Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
- •Severe cardiac, pulmonary, renal or hepatic concomitant disease or clinical laboratory finding giving reasonable suspicious of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications.
- •Disease transformation (active) (i.e. Richter?s Syndrome, prolymphocytic leukemia).
- •Active secondary malignancy or history of malignant disease within the preceding 5 years with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or the breast.
研究者
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