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FDA Approves Phase 3 Trial Protocol of Cloretazine and Cytarabine in Relapsed Acute Myelogenous Leukemia
Alan Kessman, Chief Executive Officer, commented, “We are pleased to have successfully concluded our discussions with the FDA related to the design of this pivotal trial for our lead anticancer agent CLORETAZINE™ (VNP40101M). We look forward to getting the trial started as soon as possible.”
The trial will be a placebo-controlled double-blind randomized evaluation of Ara-C plus CLORETAZINE™ (VNP40101M) versus Ara-C plus placebo. The trial is designed to accrue 420 patients with AML in first relapse with the patients having experienced a first complete remission (CR) of at least three months but not longer than twenty-four months. Patients will be randomized at a ratio of 2:1 experimental arm : control arm. Patients will be stratified according to: (i) age and (ii) length of the first CR.
The primary endpoint for the trial is the objective response rate defined as CR plus CRp (a complete remission with incomplete recovery of the platelet count). The trial has been designed to demonstrate a 50% difference in the objective response rate between the experimental arm and the control arm. Secondary endpoints include time-to-progression, duration of response, survival and toxicity.
An interim analysis is planned after accrual and adequate follow up for the objective response rate of the first 210 patients. The Company expects the trial to commence in the first quarter of 2005 and estimates that patient accrual will take place over 30 months in multiple centers in the North America and Europe.
Source: Vion Pharmaceuticals