Combination Study of Deferasirox and Erythropoietin in Patients With Low- and Int-1-risk Myelodysplastic Syndrome.

Official Title

An Open-label, Phase II, Randomized, Pilot Study to Assess the Effect in Term of Erythroid Improvement of Deferasirox Combined With Erythropoietin Compared to Erythropoietin Alone in Patients With low-and Int-1-risk Myelodysplastic Syndrome.


The primary purpose of this trial is to assess the effect of treatment with deferasirox combined with erythropoietin vs. erythropoietin alone on erythropoiesis in patients with low- and int-1-risk myelodysplastic syndrome. The addition of deferasirox to erythropoietin could lead to a potential synergism with the reduction of reactive oxygen species, through both the NF-kB pathway and the control of free toxic iron. This may create a better environment in the bone marrow for a better response with erythropoietin. This study is designed to test in a prospective way the combination of deferasirox with erythropoietin in term of their effect on hematopoiesis.

Trial Description

Primary Outcome:

  • Change in hemoglobin levels
Secondary Outcome:
  • Change in hemoglobin, platelets and neutrophil levels
  • Change in hemoglobin levels
  • Time to erythroid response
  • Time to hematologic response
  • Duration of erythroid response
  • Number of adverse events (AEs) and serious adverse events (SAEs)
  • Iron parameters by change in serum ferritin
  • Change in platelets and neutrophil levels
  • Time to hematologic improvement

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Canadian Cancer Society

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