A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS
NCT ID: NCT03223961
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
124 participants
INTERVENTIONAL
2018-03-26
2028-10-01
Brief Summary
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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)
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early onset arm
Intervention: early onset of Eprex60000 IU/week , at patient inclusion
EPREX
60 000 U/week for at least 12 weeks
Delayed onset arm
Intervention: late introduction of Eprex60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia).
EPREX
60 000 U/week for at least 12 weeks
Interventions
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EPREX
60 000 U/week for at least 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. MDS according to WHO 2016 criteria, with low or int 1 classical IPSS
3. Non-RBC transfusion dependent anemia
4. Hb level between 9 and 10.5g/dl (at the center's lab)
5. Hb level should be at least 1g/dl higher than the Hb threshold chosen to start RBC transfusions based on age, comorbidities and predicted clinical tolerance of anemia (this transfusion threshold should be chosen between 8 and 9g/dl)
6. Serum EPO level \<500U/l
7. No other cause of anemia (including iron deficiency, vitamin B12 or B9 deficiency, hemolysis, hypothyroidism….)
8. Performance status \<=2
Exclusion Criteria
2. Del 5q
3. Baseline Hemoglobin level \> 10.5 g/dl or \<9g/dl
4. Transfusion threshold (based on age , comorbidities…) \>9g/dl
5. Transfusion threshold less than 1 g/dl below baseline Hb level
6. RBC transfusion dependence. Patients may have received only one transfusion series for MDS prior to inclusion
7. CMML , if \>10 % BM blasts or WBC\>13.000/mm3
8. Uncontrolled hypertension
9. Uncontrolled cardiovascular disease including angina pectoris or cardiac failure
10. Renal failure: Creatinine clearance\<40ml/min (using MDRD formula)
11. Pregnancy (positive bettaHCG) or nursing
18 Years
ALL
No
Sponsors
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Groupe Francophone des Myelodysplasies
OTHER
Responsible Party
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Principal Investigators
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Sophie Park, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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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
Countries
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Other Identifiers
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GFM-EPO-PRETAR
Identifier Type: -
Identifier Source: org_study_id
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