EUCTR2011-005329-27-IT进行中（未招募）不适用
Phase 2 multicenter study to assess the efficacy and the safetyof front-line Fludarabine, Cyclophosphamide and Ofatumumab(FCO2) chemoimmunotherapy in young (=65 yrs) patientswith Chronic Lymphocytic Leukemia (CLL)
G.I.M.EM.A.Gruppo Italiano Malattie Ematologiche dell'Adulto0 个研究点开始时间: 2013年5月29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
- •-B-cell CLL diagnosis by 2008 revised IWCLL criteria.
- •-Treatment requirement according to the 2008 revised IWCLL criteria.
- •-No previous treatment.
- •-Age > 18 year and = 65 years.
- •-ECOG performance status of 0-1 at study entry and CIRS score =6.
- •-Adequate renal function (creatinine clearance=60 ml/min estimated using the Cockcroft-Gault equation) .
- •-For male and female subjects of childbearing potential, agreement to use effective contraception.
- •-Signed written informed consent according to ICH/EU/GCP and national local laws.
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease and/or laboratory abnormality which in the opinion of the investigator may represent a risk for the patient and/or that would prevent the subject from signing the informed consent form.
- •-Pregnant or lactating females.
- •-Known positive serology for HIV.
- •-Positive serology for Hepatitis B (HBV) defined as a positive test for HBsAg and HBV-DNA.
- •-HCV-RNA positive.
- •-Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection, tuberculosis and active hepatitis.
- •-History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
- •-Known presence of alcohol and/or drug abuse.
- •-Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to the inclusion in the study, congestive heart failure (NYHA III-IV), arrhythmia unless controlled by therapy.= grade 2 neuropathy; history of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae.
- •-Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
- •-One or more laboratory abnormalities:
- •1.Calculated creatinine clearance (Cockroft-Gault)<60mL/min.
- •2.Absolute granulocyte count <1500/µL not disease related.
- •3.Platelet count < 75000/µL not disease related.
- •4.GOT, GPT, ?GT, alkaline phosphatase > 1,5 x upper limit of normal value unless due to disease involvement); serum bilirubin >1.5mg/dL, subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones)
- •-Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrolment, whichever is longer, or currently participating in any other interventional clinical study
- •-Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
研究者
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