Vion Announces Suspension Of Phase III Trial In Relapsed AML
VION will suspend enrollment and further patient treatment in its Phase III clinical study of Cloretazine for patients with relapsed adult myelogenous leukemia pending a detailed review of all of the data from the trial.
This decision was based on the recommendation of the trial's independent Data Safety Monitoring Board (DSMB) after a planned interim analysis.
he Phase III trial is a double-blind placebo-controlled randomized evaluation of an experimental treatment consisting of Ara-C plus Cloretazine (VNP40101M) versus a control arm regimen of Ara-C and placebo. The trial is designed to accrue patients in first relapse AML whose first complete remission (CR) was more than three months but less than twenty-four months in duration. Patients are stratified according to: (i) age, greater than or less than 60 years and (ii) length of the first CR, more than or less than 12 months in duration. The primary endpoint for the trial is the objective response rate, defined as CR plus CRp (a complete remission with incomplete recovery of platelet count). Secondary endpoints include time to progression, duration of response, overall survival and toxicity.
The DSMB's review of clinical data from the first 210 treated patients resulted in a recommendation that enrollment and further treatment of patients on study be suspended. The DSMB's recommendation was based on their evaluation that any advantage in complete remission could be compromised by the observed on-study mortality to date.
The study will remain blinded while a complete medical review is conducted.
Alan Kessman, Chief Executive Officer, stated, "There will be a thorough analysis of all the data to date from this trial, and we will base any decision on the continuation, possible modification or termination of the study on the available data." He concluded, "We will provide an update on the status of the analysis as soon more information is available."
The Company is also evaluating Cloretazine (VNP40101M) as a single agent in a pivotal Phase II trial in elderly patients with de novo poor-risk AML. This trial is being conducted in over twenty sites in the U.S. and Europe. Completion of accrual to this trial is expected to occur in June or July 2007.