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

Groupe Francophone des Myelodysplasies

Status and phase

Unknown

Phase 2

Conditions

Anemia in Myelodysplastic Syndromes

Treatments

Drug: Epoetin/Atra

Study type

Interventional

Funder types

Other

Identifiers

040759

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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