Genzyme Completes Enrollment in Pivotal, Phase 2 Clinical Trial of Clofarabine in Adult AML
Genzyme Corp. announced that the company has completed enrollment of a phase 2 clinical trial examining the safety and effectiveness of Clolar® (clofarabine) in previously untreated, older adult patients with acute myelogenous leukemia (AML) who are unlikely to benefit from standard induction therapy. Data from this study are expected to provide substantial evidence for expanding the current product label into adult AML.
Genzyme has held preliminary discussions with the U.S. Food and Drug Administration in advance of submitting a supplemental new drug application (sNDA) for clofarabine as an initial treatment in older adults with AML. The company expects to file this sNDA in the second half of next year.
The clinical trial, known as CLASSIC II, is designed to address a high unmet medical need among older AML patients who currently have limited treatment options. This study builds on promising results from two phase 2 studies of clofarabine in previously untreated older patients with AML deemed unfit for chemotherapy. These studies were conducted by Alan Burnett, M.D., of Cardiff University in the United Kingdom.
The CLASSIC II trial was designed to enroll 109 patients at 20 sites in the U.S. Patients must have AML, be 60 years or older and have at least one of the following adverse prognostic factors: age greater than or equal to 70, prior hematological disorder such as myelodysplastic syndromes (MDS), poor health performance, or intermediate or unfavorable cytogenetics.
The primary endpoint is overall remission rate measured as either complete remission or complete remission with incomplete platelet recovery. Secondary endpoints include duration of remission, disease free survival, overall survival, safety and thirty-day mortality rate.
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