[摘要]：We conducted this study to determine the feasibility and safety of cladribine followed by rituximab in patients with hairy cell leukemia including the variant form (HCLv). Cladribine 5.6 mg/m(2) given IV over 2 hours daily for 5 days was followed similar to 1 month later with rituximab 375 mg/m(2) IV weekly for 8 weeks. Responses were recorded and BM minimal residual disease (MRD) was evaluated after the completion of rituximab. Thirty-six patients have been treated including 5 with HCLv. Median age was 57 years (range, 37-89). All patients (100%) have achieved complete response (CR), defined as presence of no hairy cells in BM and blood with normalization of counts (absolute neutrophil count [ANC] > 1.5 x 10(9)/L, hemoglobin [Hgb] > 12.0 g/dL, platelets [PLT] > 100 x 10(9)/L), as well as resolution of splenomegaly. There were no grade 3 or 4 nonhematologic adverse events directly related to the treatment. Only 1 patient (with HCLv) has relapsed; median CR duration has not been reached (range, 1 + -63+ months). Three patients with HCLv died including 1 with relapsed disease and 2 from unrelated malignancies. Median survival duration has not been reached (range, 2 + -64+ months). Treatment with cladribine followed by rituximab is effective tk;4 and may increase CR rate. This study was registered at www.clinicaltrials.gov as NCT00412594. (Blood. 2011; 118(14):3818-3823)
