ILEX Oncology & LeukoSite report results from pivotal Phase II CAMPATH (R) trial; Results suggest new hope for refractory chronic lymphocytic leukemia

der to reduce the incidence and severity of infusion-related adverse events. Patients also received prophylactic anti-infective treatment to reduce the risk of opportunistic infections. The primary endpoint for this trial was overall response rate (complete and partial response), and the study objective was to demonstrate a major response rate of at least 20 percent. Response rate was assessed by an independent review panel in accordance with the National Cancer Institute's guidelines for the diagnosis and treatment of CLL.

Of 93 evaluable patients, 31 demonstrated an objective response to treatment, for an overall response rate of 33%. Two of these responses were complete (2%) and 29 were partial responses (31%). Another 55 (59%) patients had disease stabilization. Median survival time has not yet been reached at about 10 months after the last patient was enrolled.

The safety profile of CAMPATH was consistent with that seen in previous studies and was judged by the investigators to be acceptable in this group of endstage CLL patients.

Adverse effects associated with CAMPATH in this study of 93 patients were mostly mild to moderate infusion-related symptoms. Severe (grade 3 and 4) infusion-related symptoms included: fever (13%), rigors (11%), dyspnea (6%), and hypotension (1%). During the study patients developed severe (grade 3 and 4) thrombocytopenia (low platelet count, 51%) or neutropenia (low white blood cell count, 61%) that usually improved within two months post-therapy. Some patients entering the study with severe (grade 3 and 4) thrombocytopenia and neutropenia improved to grade 2 or better within two months post-therapy: thrombocytopenia -- 7 of 19 (37%) patients improved,neutropenia -- 11 of 17 (65%) patients improved.

No unexpected serious adverse events were reported. The incidence of serious infections was reported to be 20% on this trial. It should be noted that infection is a common complication and cause of death

Contact: Deborah Sibley, ILEX Oncology
Porter Novelli

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