This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
After an initial subcutaneous dose escalation of alemtuzumab over 2 days, 30 mg alemtuzumab s.c., cyclophosphamide 200 mg/m2 i.v. and 25 mg/m2 fludarabine i.v. were administered on three consecutive days. Treatment was repeated after 28 days for up to six cycles
University of Cologne
Cologne, North Rhine-Westphalia, Germany
Overall response rate (complete and partial response rate)
Response Evaluation has to be done according the the NCI guidelines
Time frame: 28 days after the end of the last cycle
Toxicity
Time frame: 28 days following the last dose of FCCam
MRD response rate
Time frame: 28 days after the end of the last cycle
Response rate in biological defined risk groups
Time frame: 28 days after the end of the last cycle
Duration of response
Time frame: up to 36 months after the end of treatment
Treatment administration (dose intensity)
Time frame: up to the last day of the last given cycle (day 28 of the 6th cycle)
Overall survival
Time frame: up to 36 months after the end of treatment
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