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ACTIVE NOT RECRUITING
NCT03223961
PHASE3

A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS

Sponsor: Groupe Francophone des Myelodysplasies

View on ClinicalTrials.gov

Summary

This is an open-label, randomized, multicenter, phase III study Patients with baseline Hb comprised between 9 and 10.5g/dl will be randomized to receive EPO Alfa 60000 UI/week for at least 12 weeks: * Either at diagnosis Or * at the Hb threshold chosen for RBC transfusions (must be \< 9g/dl)

Official title: A Randomized Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS With Non RBC Transfusion Dependent Anemia and Without Del 5q

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2018-03-26

Completion Date

2028-10-01

Last Updated

2025-03-11

Healthy Volunteers

No

Interventions

DRUG

EPREX

60 000 U/week for at least 12 weeks

Locations (39)

Chu Amiens

Amiens, France

CH Angers

Angers, France

CH Avignon

Avignon, France

Centre Hospitalier de La Cote Basque

Bayonne, France

Hopital Nord Franche-Comté

Belfort, France

CHU de Besançon

Besançon, France

Hopital Avicenne

Bobigny, France

Hôpital Morvan

Brest, France

CHU de Caen

Caen, France

CH de Sevigné

Cesson, France

CH de Cholet

Cholet, France

CHU Estaing

Clermont-Ferrand, France

CHSF Gilles de Corbeil

Corbeil-Essonnes, France

Hôpital Henri-Mondor

Créteil, France

CHU de Grenoble

Grenoble, France

Centre Hospitalier du Mans

Le Mans, France

Clinique Victor Hugo

Le Mans, France

Hopital Saint-Vincent de Paul

Lille, France

CHRU Limoges

Limoges, France

Centre Hospitalier Lyon Sud

Lyon, France

IPC

Marseille, France

Centre Hospitalier du Mont de Marsan

Mont-de-Marsan, France

CHU de Nantes

Nantes, France

CHU de Nice

Nice, France

Hopital St Louis T4

Paris, France

Centre Hospitalier Joffre-Perpignan

Perpignan, France

Sophie Dimicoli-Salazar

Pessac, France

CH de Périgueux

Périgueux, France

CHU de Poitiers

Poitiers, France

CHR d'Annecy

Pringy, France

CHRU de Reims

Reims, France

CHU Pontchaillou

Rennes, France

Centre Henri Becquerel

Rouen, France

CH Saint Nazaire

Saint-Nazaire, France

Centre Hospitalier Universitaire de STRASBOURG

Strasbourg, France

IUCT Oncopole

Toulouse, France

CH de Troyes

Troyes, France

CH Valence

Valence, France

CHU Brabois

Vandœuvre-lès-Nancy, France