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B-cell chronic lymphocytic leukemia : six infection-related deaths reported after treatment with Fludarabine, Rituximab and Alemtuzumab

Bayer Schering Pharma AG and Genzyme Europe BV have informed Healthcare Professionals on six infection-related deaths, reported from a trial ( CALGB10101 ) in which previously untreated, symptomatic B-cell chronic lymphocytic leukemia patients were treated with Fludarabine ( Fludara ) and Rituximab ( MabThera, Rituxan ) followed by Alemtuzumab ( MabCampath ) for remission consolidation.

MabCampath is approved for the treatment of patients with B-cell chronic lymphocytic leukaemia ( B-CLL ) for whom Fludarabine combination chemotherapy is not appropriate and should not be used as consolidation therapy following induction with Fludarabine + Rituximab outside of a clinical trial.

Fludarabine, Rituximab and Alemtuzumab all have known immunosuppressive properties, and it is possible that the fatal infectious complications which occurred in this trial are the result of a prolonged period of immunosuppression resulting from the sequencing of these drugs without sufficient time for recovery, as well as other factors specific to this trial.

Source: MHRA, 2008