Bendamustine plus mitoxantrone -: A new effective treatment for advanced chronic lymphocytic leukaemia:: Results of a phase I/II study

The toxicity and efficacy of the combination bendamustine plus mitoxantrone ( BM) was evaluated in 22 patients with advanced chronic lymphocytic leukaemia (CLL). Twenty out of twenty-two patients had received at least one prior regimen. Median age was 71 years ( range 53 - 86). Six out of twenty-two patients were Binet stage B and 16/22 Binet stage C. Bendamustine was given in escalating doses from 80 up to 240 mg/m(2) divided in two to three doses per course, mitoxantrone was given as short infusion with 8 up to 10 mg/m(2) per course. The number of courses was limited to six and chemotherapy stopped when a complete remission (CR) or partial remission ( PR) according to NCI-Criteria was achieved. Haematotoxicity and infection were dose limiting with 4/6 patients suffering from grade 3 infectious complication in the bendamustine level with 240 mg/m(2). Six out of twenty-two patients achieved a CR and 13/22 patients a PR resulting in an overall response rate of 86% (19/22 patients). Median time to progression was 10 months ( range 4 - 22) and median survival 39 months ( range 6 - 50). For further studies we recommend a bendamustine dose of 150 mg/m(2) combined with 10 mg/m(2) mitoxantrone.