A Phase 3 interventional study of EPREX in Myelodysplastic Syndromes, sponsored by Groupe Francophone des Myelodysplasies. Active, not recruiting at 39 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Groupe Francophone des Myelodysplasies · Phase 3, Interventional, and Treatment
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:
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
Exclusion Criteria:
Intervention: early onset of Eprex60000 IU/week , at patient inclusion
Drug: EPREX
Intervention: late introduction of Eprex60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia).
Drug: EPREX
60 000 U/week for at least 12 weeks
Also known as: Epoetin alfa
Time to RBC transfusion dependence in non RBC transfusion dependent lower risk MDS patients with anemia with early (at inclusion of the patient) versus delayed onset,( at the threshold chosen for RBC transfusion) of EPO ALFA
RBC transfusion dependence will be defined by requirement of at least transfusions of 2 PRBC within an interval of less than 8 weeks, given for Hb \<8g/dl or \<9g/dl according to comorbidities and in the absence of other cause of anemia (bleeding, surgery…), taking into account only transfusions given at least 12 weeks after onset of treatment with EPO ALFA.
Time frame: 12 weeks
Erythroid response (according to IWG 2006 criteria)
Erythroid response (according to IWG 2006 criteria) after 12 weeks of EPO ALFA treatment
Time frame: 12 weeks
response duration to EPO ALFA
response duration to EPO ALFA measured from the date of enrollment until failure
Time frame: 4 years
Overall survival
Overall survival measured from the date of enrollment to death or the date of last contact
Time frame: 4 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Groupe Francophone des Myelodysplasies