A Phase II Study of Ribavirin in Refractory of Relapsed Acute Myelocytic Leukemia M4 and M5 Subtypes
The eukaryotic translation initiation factor eIF4E is dysregulated in many human
malignancies, including a subset of myeloid leukemia (M4/M5 AML and blast crisis CML). eIF4E
overexpression leads to oncogenic transformation. Ribavirin impedes eIF4E mediated
transformation in vitro, in primary human specimens and in animal models.
While ribavirin has been used extensively for the treatment of viral hepatitis C and its
safety profile has been well defined, it has never been used in patients with AML. This
study will establish the efficacy and safety of ribavirin in M4/M5 AML patients. In
addition, this study will also include correlative studies to determine the effect of
ribavirin on eIF4E activity and eIF4E related pathways in M4/M5 AML patients.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Measure: Overall response rate
Sarit Assouline, MD
Jewish General Hospital
Canada: Health Canada