Background and objectives: Although alemtuzumab (campath-1H) has been successfully used in patients with untreated or previously treated chronic lymphocytic leukemia (CLL), a variable incidence of cytomegalovirus (CMV) reactivation has been described. No prospective reports currently provide results of the use of oral ganciclovir as pre-emptive therapy in patients with CMV reactivation during alemtuzumab treatment.
Design and methods: We designed a prospective study in 12 patients with pretreated CLL with the aim of evaluating the incidence of CMV reactivation during alemtuzumab treatment and the role of oral ganciclovir as pre-emptive therapy and in preventing CMV organ disease.
Results: In the 12 CLL patients being treated with alemtuzumab, 8 patients (66%) had CMV reactivation, as detected by antigenemia and/or CMV DNA. No patient showed clinical evidence of CMV disease. The alemtuzumab was discontinued and the patients were immediately treated with oral ganciclovir 1000 mg tid. After a median of 14 days of antiviral therapy all patients achieved negative CMV polymerase chain reaction (PCR) assays and/or antigenemia. No patients showed further CMV reactivation up to the end of the study.
Interpretation and conclusions: CMV reactivaction, studied with periodic analysis of antigenemia and PCR, is frequent in previously treated CLL patients receiving alemtuzumab therapy although only sporadic cases of CMV disease have been reported. Using oral ganciclovir, the response to therapy was prompt, there was no progression to CMV disease, and no relevant clinical toxicity, thus sparing unnecessary hospitalization. Oral ganciclovir may be used as pre-emptive therapy in all patients who develop CMV reactivation during alemtuzumab treatment.