Anemia in Myelodysplastic Syndromes
Conditions
Keywords
Anemia, myelodysplastic syndromes, Low risk, Bone Marrow diseases
Brief 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
Interventions
DRUGEpoetin/Atra
Sponsors
Groupe Francophone des Myelodysplasies
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the tolerance of this treatment | — |
Countries
France
Outcome results
None listed