Alemtuzumab: Infection-Related Deaths

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Alemtuzumab: Infection-Related Deaths

United Kingdom - Bayer Schering Pharma AG and Genzyme Europe BV have informed

physicians of six infectionrelated deaths, reported from a trial (CALGB10101) in

which previously untreated, symptomatic B-cell chronic lymphocytic leukemia

(CLL) patients were treated with fludarabine and rituximab followed by

alemtuzumab for remission consolidation. Alemtuzumab (MabCampath®) is approved

for the treatment of patients with B-cell chronic lymphocytic leukaemia (BCLL)

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.

The five fatal infections were reported as: viral meningitis, Listeria

meningitis, Legionella pneumonia, cytomegalovirus infection and Pneumocystis

jiroveci pneumonia, all in patients who achieved a complete response after

induction therapy.

References:

1. Communication from Bayer Schering Pharma AG and Genzyme Europe BV at

http://www.mhra.gov.uk

2. Lin TS, Donohue KA, Lucas MS, Byrd JC, Bengtson EM, BL, Larson RA

(Cancer and Leukemia Group B USA). Consolidation therapy with subcutaneous (SC)

alemtuzumab results in severe infections toxicity in previously untreated CLL

patients who achieve a complete response (CR) after fludarabine and rituximab

(FR) induction therapy: Interim Satefy Analysis of the CALGB Study 10101.

Blood2007 Nov;110(11): 232a233a, [Abstract 755]

3. CALGB10101 abstract available online at http://www.hematology.org .