Treatment of advanced, relapsed chronic lymphocytic leukemia (CLL) with fludarabine, miroxantrone and cyclophosphamide combination therapy with or without granulocyte colony stimulating factor (G-CSF)
Completed
- Conditions
- Relapsed B-cell chronic lymphocytic leukemia (B-CLL)Lymphoid leukaemiaCancer
- Registration Number
- ISRCTN31486124
- Lead Sponsor
- German CLL Study Group (GCLLSG) (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 165
Inclusion Criteria
1. B-cell chronic lymphocytic leukemia (B-CLL)
2. Binet stage C, Binet stage B with treatment indication
3. Maximum of 3 previous treatment regimen
4. Age 18-70 years
5. Life expectancy more than 6 months
6. Eastern Cooperative Oncology Group (ECOG) 0-3
7. Normal cardiac function
8. Signed inform consent
Exclusion Criteria
1. Severe organ dysfunction
2. Autoimmune haemolytic anaemia (AIHA)
3. More than 3 chemotherapy regimens
4. Concomitant or previous neoplasm
5. Non-response to previous treatment with Fludarabine + Cyclophosphamide, Fludarabine + Mitoxantrone, Fludarabine + Epirubicine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method