Treatment of advanced, relapsed chronic lymphocytic leukemia (CLL) with fludarabine, miroxantrone and cyclophosphamide combination therapy with or without granulocyte colony stimulating factor (G-CSF)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2005
INTERVENTION: Fludarabine 25 mg/m^2 day 1‐3, mitoxantrone 8 mg/m^2 day 1, cyclophosphamide 200 mg/m^2 day 1‐3, repeated every 28 days, maximum 6 courses. Arm A with G‐CSF: 5 µg/kg bodyweight/day subcutaneously (sc) beginning on day +6 until neutrophil recovery above 1500/µl. Arm B without G‐CSF. CONDITION: Relapsed B‐cell chronic lymphocytic leukemia (B‐CLL) ; Cancer ; Lymphoid leukaemia PRIMARY OUTCOME: 1. Incidence of severe and life threatening infections; 2. Incidence of severe side effects; 3. Remission rate SECONDARY OUTCOME: 1. Overall survival; 2. Progression free survival; 3. Quality of remission 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
Epistemonikos ID: c952909bc81b60b138328e4cbf3aa96aefa2e128
First added on: Aug 21, 2024