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Leucémie lymphocytique chronique (CLL), Binet de stade A
Randomized phase III trial comparing early treatment with fludarabine, cyclophosphamide + rituximab versus deferred treatment in untreated Binet stage A patients with high risk of progression. Protocol ID
German CLL study group (GCLLSG) and French Cooperative Group Local Principal
Primary Objective
1) A comparison of the effect of immediate versus deferred treatment with FCR in Binet stage A patients at high risk for disease progression 2) Investigation and definition of a new prognostic staging system for Inclusion/exclusion
Inclusion Criteria include the following :
• Established diagnosis ofB-CLL by NCI criteria (Cheson et al., 1996). diagnosis will be retrospectively confirmed by an expert review committee. Immunophenotyping should be stored in list mode and • First diagnosis within 12 months before inclusion in study. Start of therapy possible within 28 days after completed risk • No prior chemotherapy, radiation or antibody treatment. Written informed consent of patient and treating physician. • AlI parameters for risk stratification present. • Willingness to accept contraception if randomized to cohort I for the duration of therapy and 12 months thereafter. • Negative serum pregnancy test one week prior to treatment for • Ability to understand the protocol. • Possibility of follow up. Exclusion criteria include the following :
• Age < 18 years. • ECOG performance status > 2. • Clinically apparent auto immune cytopenia, in particular antiglobulin test positive hemolytic anemia (positive antiglobulin test without anemia is not an exclusion criterion). • Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease other than B-CLL prior to the study. • Medical condition requiring the prolonged (estimated to be more than one month) use of oral corticosteroids. • History of anaphylactic reaction following exposure to humanized • Patients with active bacterial, viral or fungal infection. • Known infection with HIV, Hepatitis B or C. • Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study. • Pregnancy and/or nursing. • Concurrent severe diseases which exclude the administration of o Heart insufficiency NYHA grade III/IV, LVEF < 50% and or RF < 30%, myocardial infraction within the past 6 months prior to study o Severe chronic obstructive lung disease with hypoxemia o Impaired renal function with creatinine clearance < 70 ml/min according to the formula of Cockroft and Gault. o Cerebral dysfunction or any other coexisting medical or psychological condition that would preclude participation in therequired study procedures. • Transformation to aggressive B-cell malignancy (i.e. diffuse large cell lymphoma, Richter’s syndrome or prolymphocytic leukemia


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21048 neostrata green phas.qxd

21048 Neostrata Green PHAs.qxd 2/12/02 5:13 PM Page 1Polyhydroxy Acids (PHAs) Provide Conditioning Effects to Skin Without Increasing Sensitivity to UV LightBarbara A. Green, R.Ph., Richard H. Wildnauer, Ph.D., Brenda L. Edison NeoStrata Company, Inc., Princeton, NJ, USA Self Assessment COMPATIBILITY OF A PHA REGIMEN WITH TOPI

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