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

Myelodysplastic Syndromes Clinical Trial

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

Status Recruiting

Clinical Trial 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)

Clinical Trial Description

in this trial we will compare the early introduction of EPO alfa to the delayed introduction in lower risk MDS with non RBC transfusion dependent anemia.

At enrollment patients will be randomised in the 2 arms (early and delayed start of EPO alfa).

Treatment Regimen Epoetin alfa 60000 UI/week for at least 12 weeks

1. Early onset arm: early onset of EPO ALFA 60000 IU/week , at patient inclusion

2. Delayed onset arm: late introduction of EPO ALFA 60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia). ;

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia

• NCT number: NCT03223961
• Study type: Interventional
• Source: Groupe Francophone des Myelodysplasies
• Contact: Sophie Park, Prof
• Phone: +33 (0)4 76 76 62 77
• Email: spark@chu-grenoble.fr
• Status: Recruiting
• Phase: Phase 3
• Start date: March 26, 2018
• Completion date: May 16, 2024