Treatment of the Anemia of Myelodysplastic Syndromes by the Association of Epoetin Beta and All Trans Retinoic Acid
NCT ID: NCT00437450
Last Updated: 2009-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
99 participants
INTERVENTIONAL
2004-10-31
2005-09-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Epoetin/Atra
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Groupe Francophone des Myelodysplasies
OTHER
Principal Investigators
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Lionel ADES, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe Francophone des Myelodysplasies
Locations
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CHU d'Amiens
Amiens, , France
CHU d'Angers
Angers, , France
CHU d'Avignon
Avignon, , France
CH de la cote Basque
Bayonne, , France
Hopital Avicenne
Bobigny, , France
CHU de Caen
Caen, , France
Hopital Percy
Clamart, , France
CHU Dijon
Dijon, , France
CHU Albert Michallon
Grenoble, , France
CHRU Limoges
Limoges, , France
CHU Edouard Herriot
Lyon, , France
Institut Paoli Calmette
Marseille, , France
CHU Archet
Nice, , France
Hopital Necker
Paris, , France
Hopital Saint Antoine
Paris, , France
HOPITAL Cochin
Paris, , France
Hopital Hotel Dieu
Paris, , France
CH de Cournouaille
Quimper, , France
CHU Robert Debre
Reims, , France
Hopital Henri Becquerel
Rouen, , France
Hopital Hautepierre
Strasbourg, , France
Chu Purpan
Toulouse, , France
CHU Bretoneau
Tours, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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040759
Identifier Type: -
Identifier Source: org_study_id
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