NCT03223961 (EPO-PRETAR) is a Phase 3 clinical trial of EPREX in Myelodysplastic Syndromes, sponsored by Groupe Francophone des Myelodysplasies.

Who is sponsoring NCT03223961?

NCT03223961 is sponsored by Groupe Francophone des Myelodysplasies.

What drugs are being tested in NCT03223961?

Interventions in NCT03223961: EPREX.

What condition does NCT03223961 study?

NCT03223961 studies Myelodysplastic Syndromes.

Is NCT03223961 still recruiting?

NCT03223961 is currently active, enrolled. Last updated 11 March 2025.

Last reviewed 2025-03-11 · How we verify

NCT03223961: EPO-PRETAR

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS

Active, enrolled Phase 3 Last updated 11 March 2025

What this trial tests

Phase 3 trial testing EPREX in Myelodysplastic Syndromes in 124 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 March 2018

Primary endpoint
21 September 2023

1 October 2028

Quick facts

Lead sponsor	Groupe Francophone des Myelodysplasies
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	124
Start date	26 March 2018
Primary completion	21 September 2023
Estimated completion	1 October 2028
Sites	39 locations across France

Drugs / interventions tested

EPREX — full drug profile →

Conditions studied

Myelodysplastic Syndromes — all drugs for Myelodysplastic Syndromes →

Sponsor

Groupe Francophone des Myelodysplasies — full company profile →

Who can join

18 and older, any sex, with Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Lower-risk myelodysplastic syndromes: Current treatment options for anemia.
Meunier M, Park S. · · 2022 · cited 9× · PMID 36467818 · DOI 10.1002/jha2.523
Molecular Insights and Therapeutic Advances in Low-Risk Myelodysplastic Neoplasms: A Clinical Review.
Dhillon V, Maciejewski J, Balasubramanian SK. · · 2025 · cited 1× · PMID 41300977 · DOI 10.3390/cancers17223610

Verify or expand the search:

Other trials of EPREX

Trials testing the same drug.

NCT03276910 — Evaluation of Erythroferrone as a New Biomarker of Erythropoesis Stimulating Agents · Phase 1 · unknown

Other recruiting trials for Myelodysplastic Syndromes

Currently open trials in the same condition.

NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT06303193 — Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or · Phase 1, PHASE2 · recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting
NCT07283900 — Ascorbate in Myelodysplastic Syndrome · Phase 2 · recruiting
NCT06487247 — HEME Home Transfusion Program · NA · recruiting

Other Groupe Francophone des Myelodysplasies trials

Trials by the same sponsor.

NCT05226455 — Venetoclax in Patients With MDS or AML in Relapse After AHSCT · Phase 1, PHASE2 · active not recruiting
NCT05181735 — Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA · Phase 1, PHASE2 · recruiting
NCT04857645 — ASTX727 and Donor Lymphocyte Infusions After Allogenic Stem Cell Transplantation in Very High Risk MDS or AML Patients · Phase 2 · completed
NCT04827719 — BST-236 as a Single Agent in Adults With Relapsed or Refractory AML or HR-MDS · Phase 2 · completed
NCT04273802 — CPX-351 in Higher Risk Myelodysplastic Syndromes · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03223961 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Groupe Francophone des Myelodysplasies
Last refreshed: 11 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03223961.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing