Assessment of Efficacy and Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab Chemoimmunotherapy in Young Patients With Chronic Lymphocytic Leukemia.

Inclusion Criteria: * 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-Gaultequation) . * For male and female subjects of childbearing potential, agreement to use effective contraception. * Signed written informed const according to ICH/EU/GCP and national local laws. Exclusion Criteria: * 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/ƒÊL not disease related. 3. Platelet count \< 75000/ƒÊL 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 enrollment, 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.