Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome (MDS)
Patients with myelodysplastic syndrome (MDS) present with low red blood cells, white blood
cells and platelets, alone or in combination. The only definitive treatment is stem cell
transplantation. Unfortunately, treatment-related mortality precludes the application of
this procedure for most patients older than 60 years and those lacking a suitable matched
sibling donor. A proportion of patients have been shown to respond to a wide variety of
immunosuppressive agents, including cyclosporine (CSA) and antithymocyte globulin (ATG).
However, nonresponse and relapse continue to be problematic. Therefore, most patients with
MDS receive supportive treatment with transfusions and growth factors, such as
erythropoietin (EPO) and G-CSF, to improve blood counts. However, growth factors are not
always effective in improving cytopenias and iron overload is an inevitable long-term
complication of red blood cell transfusions.
Recently, Abkowitz et al described clinically significant improvement in anemia in 3 of 9
patients with Diamond-Blackfan anemia (DBA) using metoclopramide, an inexpensive, commonly
used medication with rare side effects. We hypothesize that therapy with metoclopramide
might also benefit patients with other causes of refractory anemia, such as individuals with
anemia due to MDS. We therefore propose this Phase II clinical trial to evaluate
metoclopramide in the treatment of anemia in patients with MDS.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|
|University of Washington||Seattle, Washington 98195|