NCT03223961

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

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: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Groupe Francophone des Myelodysplasies · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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).

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	EPREX	60 000 U/week for at least 12 weeks

Timeline

• Start date: 2018-03-26
• Primary completion: 2023-09-21
• Completion: 2028-10-01
• First posted: 2017-07-21
• Last updated: 2025-03-11

Locations

39 sites across 1 country: France