GFM-EPO-PRETAR: A randomized trial testing early versus late onset of EPO alfa treatment in lower risk MDS with non RBC transfusion dependent anemia and without del 5q

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515356-21-00

Acronym

GFM-EPO-PRETAR

Enrollment

124

Registered

2024-09-24

Start date

2018-04-17

Completion date

2024-10-29

Last updated

2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult subject (18 years of age older) with low or intermediate-1 IPSS risk MDS with transfusions independent anemia

Brief summary

Comparison of the time to RBC transfusion dependence between patients with early onset of EPO ALFA (at inclusion) and patients with delayed onset of EPO ALFA (at the threshold chosen for RBC transfusion)

Detailed description

IWG 2006 erythroid response and duration, QoL, OS, Molecular biology corrélations

Interventions

DRUGEPREX 40000 UI/ml

DRUGsolution injectable en seringue préremplie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Comparison of the time to RBC transfusion dependence between patients with early onset of EPO ALFA (at inclusion) and patients with delayed onset of EPO ALFA (at the threshold chosen for RBC transfusion)	—

Secondary

Measure	Time frame
IWG 2006 erythroid response and duration, QoL, OS, Molecular biology corrélations	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026