Alemtuzumab in adult T-cell leukemia

Purpose: Therapeutic regimens for ATL are limited with unsatisfactory results, thereby warranting development of novel therapies. This study investigated antitumor activity and toxicity of alemtuzumab with regard to response, duration of response, progression free survival, and overall survival in patients with human T-cell lymphotropic virus-1 (HTLV-1)-associated adult T-cell leukemia/lymphoma (ATL). Experimental Design: Twenty-nine patients with chronic, acute, and lymphomatous types of ATL were enrolled in a single institution, nonrandomized, open-label Phase II trial wherein patients received intravenous alemtuzumab 30 mg three times weekly for a maximum of 12 weeks. Results: Twenty-nine patients were evaluable for response and toxicity. The overall objective response was 15 out of 29 patients (95% CI: 32.5 to 70.6%). The 15 patients that responded manifested a median time to response of 1.1 months. Median response duration was 1.4 months for the whole group and 14.5 months among responders. Median progression free survival was 2.0 months. Median overall survival was 5.9 months The most common adverse events were 2 with vasovagal episodes (7%) and 3 with hypotensive episodes (10%), leukopenia (41%)grade 3 and (17%) grade 4, lymphocytopenia (59%) grade 3, neutropenia (31%) grade 3, anemia (24%) and thrombocytopenia 10%. All patients developed cytomegalovirus antigenemia (CMV). Three were symptomatic and all responded to antiviral therapy. Grade 3 or 4 infections were reported in 4 (14%) of patients. Conclusions: Alemtuzumab induced responses in patients with acute HTLV-1-associated ATL with acceptable toxicity, but with short duration of responses. These studies support inclusion of alemtuzumab in novel multi-drug therapies for ATL.

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