Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2026-02-25 @ 6:32 PM
Study NCT ID:
NCT03223961
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2017-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS
Sponsor:
Groupe Francophone des Myelodysplasies
Organization:
Study Overview
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPO-PRETAR
Brief 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)
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: