The primary objectives of the phase I clinical trial are to evaluate safety and identify the maximum tolerated dose of L-Annamycin, and to evaluate the antileukemia activity of L-Annamycin in children and young adults with refractory or relapsed acute lymphocytic leukemia or acute myelogenous leukemia.
The secondary objective is to measure the pharmacokinetics of annamycin and its metabolite, annamycinol.
The trial utilizes the Pediatric Oncology Experimental Therapeutics Investigators Consortium, a consortium of prestigious pediatric cancer centers that focuses on early clinical development of promising therapies for the treatment of children, adolescents and young adults with cancer.