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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
The information in this document is supplied solely as a resource for journalists. Any questions about your veterinary healthcare or treatment should be The QUEST trial is the largest global clinical study of its kind ever to be conducted amongst dogs with congestive heart failure. QUEST stands for Qu ality of Life and E xtension of S urvival T ime, and was an international, multi- ce
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