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CLL206: Alemtuzumab plus methylprednisolone produced superior results in TP53-deleted CLL
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Final results from the National Cancer Research Institute CLL206 trial showed that the combination of alemtuzumab and methylprednisolone is the most effective induction regimen for patients with TP53-deleted chronic lymphocytic leukemia found thus far.
In a single-arm, open-label trial, 39 patients underwent a maximum of 16 weeks of treatment with thrice-weekly 30 mg alemtuzumab, a humanized rat monoclonal antibody that binds to the antigen CD52, and 1 g/m2 methylprednisolone for 5 consecutive days every 4 weeks. Seventeen patients were treatment-naive.
Patients were treated at 12 sites in the United Kingdom from May 2006 to February 2008. At baseline, researchers confirmed a TP53 deletion or mutation in 37 of 39 pretreatment blood samples.
Median PFS was 11.8 months (95% CI, 6.5-18) and median OS was 23 months (95% CI, 16.4-not reached). Objective response was 82%, 14 patients had complete remission and 18 had partial remission. One patient had stable disease and six others progressed during therapy.
Nine of 25 patients tested had bone marrow minimal residual disease negativity, but only five of these patients had a radiologic complete response.
PFS was significantly longer in patients who completed all scheduled treatment (17 months vs. 7 months), had complete remission (18.3 months vs. 6 months) or who had bone marrow minimal residual disease negativity (23.5 months vs. 9.9 months). Similarly, OS was longer in patients who had complete remission (38.9 months vs. 17.3 months).
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