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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
orally, 40 mg/m2 d1-3 q4w, x4 cycles
subcutaneous, starting dose 3 mg and escalation to 10 mg, then 30 mg, followed by 30 mg thrice weekly for 16 weeks in escalated dose
Landeskrankenhaus Feldkirch
Feldkirch, Austria
A.ö. Landeskrankenhaus Fürstenfeld
Fürstenfeld, Austria
Universitätsklinik Innsbruck/ Klinik für Innere Medizin
Innsbruck, Austria
A.ö. Landeskrankenhaus Leoben
Leoben, Austria
Krankenhaus der Stadt Linz
Linz, Austria
St. Johanns LK
Salzburg, Austria
A.ö. Krankenhaus der Landeshauptstadt St. Pölten
Sankt Pölten, Austria
Klinikum Kreuzschwestern Wels GmbH
Wels, Austria
Safety and tolerability
Time frame: within the duration of study
Complete and overall response rate
Time frame: within the duration of study
Infections grade III, IV
Time frame: within the duration of study
Rate of CMV reactivation
Time frame: within the duration of study
Time to retreatment
Time frame: within duration of trial
Overall survival
Time frame: within duration of trial
Response in lymphatic compartments
Time frame: within duration of trial
Molecular response/ immunologic MRD response
Time frame: within duration of trial
Quality of Life
Time frame: within duration of trial
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