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
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Among 10 studies testing Epoetin Alfa in Myelodysplastic Syndromes — 2 open to participants now, 4 under way, 2 of them phase 3. Epoetin Alfa · Myelodysplastic Syndromes.
Among the 10 studies testing Epoetin Alfa in Myelodysplastic Syndromes, this one is the only one that started in 2018, is one of 5 in phase 3, and was the 8th registered.
1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.
Browse Myelodysplastic Syndromes studies →2 of the 10 studies testing Epoetin Alfa in Myelodysplastic Syndromes are open now, in 5 countries. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States, Canada, Puerto Rico
Ages 18+
Groupe Francophone des Myelodysplasies · Sites in France, Italy
Ages 18+
By country, each count listing its studies:
Epoetin Alfa: first FDA approval 1989 (EPOGEN/PROCRIT), first EMA approval 1997. What it is approved for, and how studies give it, is on its page →
Of the 264 Myelodysplastic Syndromes studies recruiting now, 167 (63%) set no upper age limit and 70 (27%) stop at 75 or younger; 57 take children under 18; 17 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 5 · Phase 3 5
First in 1998; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 124 is above the median of 40 across 1,611 interventional studies indexed under Myelodysplastic Syndromes.
Median enrollment 124 across the 9 interventional studies. Of the 4 that completed or were terminated, 2 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 10 have an industry lead sponsor. The 7 most frequent:
Groupe Francophone des Myelodysplasies is the lead sponsor of 44 studies on the registry; 5 are open to participants now.
29 studies in Myelodysplastic Syndromes by Groupe Francophone des Myelodysplasies: 4 open now, 8 under way, 1 of them phase 3. Of 15 finished, 1 (7%) have results posted.
Among the 29 studies in Myelodysplastic Syndromes by Groupe Francophone des Myelodysplasies, this one is the 3rd largest by planned enrollment of the 28 interventional ones that give a count, is one of 2 that started in 2018, is the only one in phase 3, and was the 19th registered.
Groupe Francophone des Myelodysplasies’s Myelodysplastic Syndromes studies by the year they started, since 2003.
None of the studies under way reaches primary completion within a year.
Among the 10 studies testing Epoetin Alfa in Myelodysplastic Syndromes, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Groupe Francophone des Myelodysplasies’s 29 in Myelodysplastic Syndromes:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Ran from Mar 2018 to primary completion in Sep 2023, 65 months.
Of 45 phase 3 interventional studies under Myelodysplastic Syndromes, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 95. This study's 65 months is above that.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Epoetin Alfa
Groupe Francophone des Myelodysplasies