Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia
Active, not recruiting
National Cancer Institute (NCI)
Phase 3
2009-01-29
This randomized phase III trial studies lenalidomide to see how well it works with or without
epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may
stop the growth of myelodysplastic syndrome by blocking blood flow to the cells. Colony
stimulating factors, such as epoetin alfa, may increase the number of immune cells found in
bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective
with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.
Biological Predictive Factors of Response to ESA in Low Risk MDS Patients
Completed
Association pour la recherche sur les Affections Malignes en Immunologie Sanguine
Phase 4
2013-01-01
In this trial, the investigators would like to understand why a small percentage of patients
will be refractory to ESA (independently of International prognostic scoring system (IPSS)
and % of blasts). In a retrospective study of the "Groupe Francophone des Myélodysplasies
(GFM)" , the investigators showed that about 43% of patients are refractory or will relapse
after initial response to ESA and it has been shown that these patients have a poorer
survival. The investigators plan to give a 12-week treatment of Epoetin alfa or zeta in low
risk MDS patients and measure different biological factors to predict response to ESA:
- evaluation by flow cytometry before and after treatment of the degree of
dyserythropoiesis and dysgranulopoiesis which could explain the primary resistance or
loss of response of a subset of patients,
- screening by molecular biology of predictive factors of response to ESA,
- Iron homeostasis will be measured via hepcidin, GDF-15 and ferritin levels.
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