Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)
Phase 2
Completed
- Conditions
- B-cell Chronic Lymphocytic Leukemia
- Interventions
- Drug: FCCam
- Registration Number
- NCT00147901
- Lead Sponsor
- German CLL Study Group
- Brief Summary
This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
- B-CLL in need of treatment
- One or two prior prior therapies
- WHO performance status 0-2
Exclusion Criteria
- Serum creatinine > 1.5 ULN
- Major organ dysfunctions
- Pregnant or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FCCam FCCam 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
- Primary Outcome Measures
Name Time Method Overall response rate (complete and partial response rate) 28 days after the end of the last cycle Response Evaluation has to be done according the the NCI guidelines
- Secondary Outcome Measures
Name Time Method Toxicity 28 days following the last dose of FCCam MRD response rate 28 days after the end of the last cycle Response rate in biological defined risk groups 28 days after the end of the last cycle Duration of response up to 36 months after the end of treatment Treatment administration (dose intensity) up to the last day of the last given cycle (day 28 of the 6th cycle) Overall survival up to 36 months after the end of treatment
Trial Locations
- Locations (1)
University of Cologne
🇩🇪Cologne, NRW, Germany