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

• Status: Unknown status
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Francophone des Myelodysplasies
• Treatments: Epoetin Alfa; Tretinoin

Criteria

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