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

Phase 2

• Conditions: Anemia in Myelodysplastic Syndromes

• Registration Number: NCT00437450
• Lead Sponsor: Groupe Francophone des Myelodysplasies

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study Completion: 2005-09
• Status Verified: 2007-02
• Study First Submitted: 2007-02-19
• Study First Submitted QC: 2007-02-19
• Study First Posted: 2007-02-21
• Last Update Submitted: 2009-11-17
• Last Update Posted: 2009-11-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes

Secondary Outcome Measures

Name	Time	Method
To evaluate the tolerance of this treatment

Trial Locations

Locations (24)

CHU d'Angers; 🇫🇷 Angers, France

CHU d'Avignon; 🇫🇷 Avignon, France

CHU de Caen; 🇫🇷 Caen, France

CHU Dijon; 🇫🇷 Dijon, France

CHU Bretoneau; 🇫🇷 Tours, France

CHU Edouard Herriot; 🇫🇷 Lyon, France

CHU d'Amiens; 🇫🇷 Amiens, France

Institut Paoli Calmette; 🇫🇷 Marseille, France

Hopital Hotel Dieu; 🇫🇷 Paris, France

Hopital Avicenne; 🇫🇷 Bobigny, France

Hopital Percy; 🇫🇷 Clamart, France

CHU Archet; 🇫🇷 Nice, France

CHU Robert Debre; 🇫🇷 Reims, France

Hopital Saint Antoine; 🇫🇷 Paris, France

CHU Albert Michallon; 🇫🇷 Grenoble, France

Hopital Necker; 🇫🇷 Paris, France

CH de Cournouaille; 🇫🇷 Quimper, France

Hopital Henri Becquerel; 🇫🇷 Rouen, France

Hopital Hautepierre; 🇫🇷 Strasbourg, France

Chu Purpan; 🇫🇷 Toulouse, France

CHU Brabois; 🇫🇷 Vandoeuvre-les-Nancy, France

CHRU Limoges; 🇫🇷 Limoges, France

CH de la cote Basque; 🇫🇷 Bayonne, France

HOPITAL Cochin; 🇫🇷 Paris, France