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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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