This decision was based on the recommendation of the trial’s independent data safety monitoring board (DSMB) after a planned interim analysis.
The phase III trial is a double-blind placebo-controlled randomized evaluation of an experimental treatment consisting of Ara-C plus Cloretazine 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.
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 its 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, CEO, commented, “we will provide an update on the status of the analysis as soon more information is available.”