Status:
UNKNOWN
Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid
Lead Sponsor:
Groupe Francophone des Myelodysplasies
Conditions:
Anemia in Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00437450
Start Date
October 1 2004
End Date
September 1 2005
Last Update
November 18 2009
Active Locations (24)
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1
CHU d'Amiens
Amiens, France, 84054
2
CHU d'Angers
Angers, France, 43033
3
CHU d'Avignon
Avignon, France, 84000
4
CH de la cote Basque
Bayonne, France, 64100