ZOOM CCL 7
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.
German CLL study group (GCLLSG) and French Cooperative Group
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 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
Java Bytecode to Native Code Translation: The Caffeine Prototype and Preliminary Results Cheng-Hsueh A. Hsieh John C. Gyllenhaal Wen-mei W. HwuCenter for Reliable and High-Performance Computing Abstract exists behind efforts to create such a software distributionlanguage. The progress, however, has been very slow due to The Java bytecode language is emerging as a software distribution
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