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Genzyme Begins Phase 3 Pivotal Study of Clolar in Adult Acute Myelogenous Leukemia
08 Sep 2006 -
Genzyme Corporation announced that the first patient has been treated in a new phase 3 clinical trial examining the safety and effectiveness of Clolar® (clofarabine) in older patients with acute myelogenous leukemia (AML). This is the first pivotal clinical study of clofarabine in adult patients with AML, and is expected to provide substantial support for expanding the current product label.
The trial, designed as a pivotal study for adult AML patients aged 60 and older previously treated with at least one, but not more than two prior induction regimens, is a randomized, double-blind, controlled study that will compare the combination of Clolar and cytarabine (Ara-C) to cytarabine alone. The study will take place at approximately 100 medical centers in the United States and Canada. It will enroll up to 376 patients with refractory or relapsed AML.
In addition to safety, the trial will evaluate the effectiveness of one dose of 40 mg/m² per day of Clolar combined with 1 g/m² per day of Ara-C, compared with 1g/m2 per day of Ara-C combined with placebo. The primary endpoint is improved overall survival. Other endpoints include overall remission rate, duration of remission, disease-free survival and event-free survival and safety and tolerability including hospitalizations. All patients will be followed for at least two years after their end of treatment visit.
A separate, phase 2 pivotal study of clofarabine in previously untreated older AML patients for whom standard induction combination chemotherapy is unlikely to be of benefit is expected to begin as early as the fourth quarter of this year. A second phase 3 study of clofarabine sponsored by the Eastern Cooperative Oncology Group is expected to begin enrolling patients early next year. This study will focus on untreated AML patients over the age of 60 who are considered suitable for standard induction chemotherapy.
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