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.

Summary:

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

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society