Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) versus Bendamustine and Rituximab (BR) alone in patients with previously untreated chronic lymphocytic leukaemia (CLL10)
Laufzeit: 01.01.2008 - 31.12.2018
Kurzfassung
Although combined chemoimmunotherapy is not a curative treatment for CLL, phase II trials have shown that a high percentage of molecular remissions with very long lasting progression free (PFS) survival can be induced by modern chemoimmunotherapy (FCR) in first line therapy of CLL. The triple combination FCR has been investigated in several phase II and in one phase III study conducted by the GCLLSG in first line therapy of CLL. These studies show the induction of long lasting remissions and...Although combined chemoimmunotherapy is not a curative treatment for CLL, phase II trials have shown that a high percentage of molecular remissions with very long lasting progression free (PFS) survival can be induced by modern chemoimmunotherapy (FCR) in first line therapy of CLL. The triple combination FCR has been investigated in several phase II and in one phase III study conducted by the GCLLSG in first line therapy of CLL. These studies show the induction of long lasting remissions and a high number of complete remissions with FCR. However, the FCR regimen causes a relatively high percentage of severe cytopenia during and after therapy. Combination therapies based on Bendamustine plus Rituximab ± Mitoxantron (BR or BMR) have shown encouraging activity in patients with relapsed/refractory NHL and in previously treated and untreated CLL. Main side effects of this treatment regimen were cytopenia as well (Table 1). The aim of this phase III trial is to investigate the non-inferiority of the BR combination in comparison to FCR with regard to the efficacy and the incidence of major side effects such as myelosuppression and rate of infections in patients with previously untreated CLL.» weiterlesen» einklappen