Ribavirin and Hedgehog Inhibitor With or Without Decitabine in AML

Official Title

A Phase II, Multi-centre, Open Label, Randomized Study of Ribavirin and Hedgehog Inhibitor With or Without Decitabine in Acute Myeloid Leukemia (AML)

Summary:

This is a research study of ribavirin which will be given in combination with vismodegib and/or decitabine. The purpose of this study is to see if patients respond to treatment when ribavirin is given with vismodegib alone or in combination with decitabine.

Trial Description

Primary Outcome:

  • Efficacy will be measured by overall response rate (ORR).
Secondary Outcome:
  • Time to response
  • Duration of response
  • One year survival
  • Overall survival
  • Hematologic improvement defined by the number of individual, positively affected cell lines (erythroid, neutrophil and platelet cells) per patient.
  • Number of participants with Adverse Events as a Measure of Safety and Tolerability
  • Changes in eIF4E expression, localization, and signalling pathways (measured by immuno-histochemical analysis, PCR or western blot) and correlating with each patient's overall response.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society