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

Anemia in Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00437450
• Other study ID #: 040759
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 19, 2007
• Last updated: November 17, 2009
• Start date: October 2004
• Est. completion date: September 2005

Study information

• Verified date: February 2007
• Source: Groupe Francophone des Myelodysplasies
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia in Myelodysplastic Syndromes
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Epoetin/Atra

Locations

Country	Name	City	State
France	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 Cochin	Paris
France	Hopital Hotel Dieu	Paris
France	Hopital Necker	Paris
France	Hopital Saint Antoine	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	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Francophone des Myelodysplasies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes
Secondary	To evaluate the tolerance of this treatment