B-cell Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Subcutaneous MabCampath® (Alemtuzumab) and Oral Fludara® (Fludarabinephosphate) for the Treatment of Refractory or Relapsed Chronic Lymphocytic Leukemia in 2nd or 3rd Line of Treatment: A Pilot Trial (FLUSALEM) for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response
Open label multicenter, two-step, non-randomized (pilot) study to analyze the safety of 4
cycles of 3-day 40mg/m2 oral fludarabine with simultaneous thrice weekly application of 30mg
alemtuzumab s.c. in patients with B-CLL disease in 1st and 2nd relapse after any primary
treatment or with disease refractory to any therapy in 1st or 2nd line (including
Fludarabine, ). This regimen is preceded by an escalation phase with 3-10-30 mg of
alemtuzumab s.c.
After the first phase (completed treatment of 7 patients) an interim analysis of safety and
efficacy will be performed. In case of a sufficient risk benefit assessment followed by the
enrollment of further 21 patients. Final analysis of safety and preliminary efficacy will be
based on all patients enrolled.
n/a
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