Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid

Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid

The purpose of this study is

• To evaluate the efficacy of association of Erythropoetin (Neorecormon) and ATRA in patients with low risk myelodysplastic syndromes
• To evaluate the tolerance of this treatment

Inclusion Criteria:

• Patients ≥18 years with RA, RARS, RAEB (blasts <10%)
• Hb< 10g/dl > of 2 months or transfused since less 2 months
• Hb<12g/dl > of 2 months and thrombocytopenia defined by platelets < 50 000/mm3, or neutropenia<10 000mm3
• For women of child bearing age, necessity of contraception during all the duration of the study

Exclusion Criteria:

• Patient with lung disease, cardiac, neurological, gastro-intestinal or genito - urinary disorders not connected to genito -urinary not connected to myelodysplasia
• Patient having received intensive chemotherapy in the 3 months before inclusion in the protocol
• RAEBt
• RAEB >10% blasts
• Treatment with rHu-Epo, darbepoetin ou rHu-GCSF , 2 months before inclusion
• Patient presenting an iron , B12 vitamin or folic acid uncorrected deficit
• CMML
• Uncontrolled systemic hypertension
• creatinine clearance < 300 µM/L
• Pregnant patient or in period of lactation
• Life expectancy < 6 months