Long-term follow up of the CLL2007FMP trial evaluating fludarabine and cyclophosphamide in combination with either rituximab or alemtuzumab in previously untreated patients with chronic lymphocytic leukemia.

In fit chronic lymphocytic leukemia (CLL) patients without chromosome 17p deletion (del(17p)) or TP53 mutation, six cycles of FCR (fludarabine, cyclophosphamide, rituximab) provides the best progression-free survival (PFS) and overall survival (OS).1,2 In 2007, the French Innovative Leukemia Organization (FILO) group initiated the CLLFMP2007 study, a phase III trial in which fit patients with previously untreated CLL were randomized to six cycles of FCR or FCCam (fludarabine, cyclophosphamide, and alemtuzumab 30 mg subcutaneously on days 1-3 every 28 days). At the time, alemtuzumab, a humanized anti-CD52 monoclonal antibody, was one of the most active for treating CLL.3 Recruitment onto the CLLFMP2007 study was prematurely stopped because of excess toxicity in the FCCam arm, including 8 deaths, 4 from lymphoma and 4 from infection, in this cohort of 165 patients. We reported the initial results in 2012 with a median follow up of 38 months.4 Here, we provide the up-dated results with a median follow up of 76.4 months with particular attention to long-term outcome, toxicity, and minimal residual disease (MRD) data. [...]