Cell Therapeutics, Inc. has announced that the University of Washington ("UW") has begun enrolling patients in a randomized phase II study testing the combination of tosedostat with either cytarabine or decitabine for elderly patients with newly-diagnosed acute myeloid leukemia ("AML") or high-risk myelodysplastic syndrome ("MDS").
Drs. John Pagel and Elihu Estey, from the University of Washington School of Medicine and Fred Hutchinson Cancer Research Center, are leading the study.
"This is the first study to examine the effects of tosedostat in combination with either cytarabine or decitabine as a first-line therapy. The study will evaluate how well patients tolerate these combinations, and their effectiveness. Given that there have been no major advances in treatment of elderly patients with AML, and the results of a previous study of tosedostat by itself in relapsed or refractory patients with AML or MDS showed promising anti-leukemic effects and acceptable tolerability, we are hopeful that this study will demonstrate that tosedostat increases the limited efficacy of these commonly used anti-leukemic agents," Dr. Estey said.
The study's primary objectives are to determine the four-month survival and complete response ("CR") rates of tosedostat in combination with either cytarabine or decitabine in untreated AML or high-risk MDS.
The study's secondary objectives are to assess the safety and tolerability of tosedostat in combination with either cytarabine or decitabine, to determine the treatment-related mortality rate (defined as death within the first 30 days of beginning treatment), and to estimate the rates of disease-free survival, one-year survival, and overall survival.