Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Early vs. Late Epoetin Alfa Treatment for Adults with Low-Risk MDS and Anemia Not Requiring Blood Transfusions

Fast replyRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Myelodysplastic Syndromes (MDS), which is a group of disorders caused by poorly formed or dysfunctional blood cells. The study specifically looks at patients with lower risk MDS who have anemia, a condition where there is a lack of healthy red blood cells, but who are not dependent on red blood cell transfusions. The treatment being tested is called Epoetin Alfa, which is a medication used to help the body produce more red blood cells.

The purpose of the study is to compare the effects of starting Epoetin Alfa treatment early versus starting it later in patients with lower risk MDS and anemia. Participants will be randomly assigned to receive the treatment either at the beginning of the study or at a later stage when their condition reaches a certain point. The study will observe how long it takes for patients to become dependent on red blood cell transfusions in both groups.

Throughout the study, participants will receive regular injections of Epoetin Alfa and will be monitored to see how their condition progresses. The study aims to provide valuable information on the best timing for starting treatment with Epoetin Alfa in patients with lower risk MDS and anemia, potentially improving their quality of life and health outcomes.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is randomly assigned to one of two groups. One group will start treatment with epoetin alfa immediately, while the other group will begin treatment later, based on specific criteria related to red blood cell (RBC) transfusion needs.

  2. Step 2

    Treatment administration

    The treatment involves the administration of epoetin alfa, which is a solution for injection. This medication is given through subcutaneous injection, meaning it is injected under the skin.

    The specific dosage and frequency of the injections are determined by the study protocol and the patient's individual needs.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's health and response to the treatment are closely monitored. This includes regular blood tests to measure hemoglobin levels and assess the need for RBC transfusions.

    Additional assessments may include evaluations of quality of life and overall survival, as well as molecular biology tests to understand the biological effects of the treatment.

  4. Step 4

    End of study participation

    The study is expected to conclude by February 28, 2025. At the end of the study, the data collected will be analyzed to compare the time to RBC transfusion dependence between the two groups.

    The results will help determine the effectiveness of early versus delayed treatment with epoetin alfa in patients with lower risk myelodysplastic syndromes (MDS) and non-RBC transfusion dependent anemia.

Who can join the trial?

7 criteria

  • Must be an adult, meaning 18 years or older.
  • Must understand and willingly sign a form that explains the study and gives permission to participate.
  • Must have a diagnosis of MDS, which stands for Myelodysplastic Syndromes, according to specific criteria set in 2016. This includes a type called CMML, but only if white blood cells are less than 13G/l.
  • Must not have a specific genetic change called 5q deletion.
  • Must have anemia, which means low red blood cell levels, but not need regular blood transfusions. The hemoglobin level, which is a measure of red blood cells, should be between 9.0 and 10.5 g/dl. It should also be at least 1g/dl higher than the level at which the doctor would start blood transfusions, based on the patient's age and health conditions.
  • Must have a serum EPO level, which is a measure of a hormone that helps make red blood cells, less than 500U/l. There should be no other reasons for anemia, like lack of iron or certain vitamins, or thyroid problems.
  • Must have a performance status of 2 or less, which means the patient is able to do most daily activities with some help.

Who cannot join the trial?

9 criteria

  • Patients who are dependent on red blood cell (RBC) transfusions cannot participate. This means if you regularly need blood transfusions to manage your condition, you are not eligible.
  • Patients with a high risk of myelodysplastic syndromes (MDS) are excluded. MDS is a group of disorders caused by poorly formed or dysfunctional blood cells.
  • Patients who have received treatment with erythropoiesis-stimulating agents (ESAs) in the past are not eligible. ESAs are medications that help your body make more red blood cells.
  • Patients with uncontrolled high blood pressure cannot participate. High blood pressure is when the force of your blood against your artery walls is too high.
  • Patients with a history of certain types of cancer are excluded. This refers to having had cancer in the past.
  • Patients with severe heart disease are not eligible. Heart disease refers to conditions that affect the heart's ability to function properly.
  • Patients with severe kidney disease cannot participate. Kidney disease affects how well your kidneys work.
  • Patients who are pregnant or breastfeeding are excluded. This means if you are expecting a baby or nursing, you cannot join the study.
  • Patients with any other medical condition that the study doctors think would make it unsafe for them to participate are not eligible. This means if there is any other health issue that could cause problems, you might not be able to join.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

EPO Alfa is a medication used in this clinical trial to help manage anemia in patients with lower risk myelodysplastic syndromes (MDS) who are not dependent on red blood cell (RBC) transfusions. The trial is investigating the effects of starting EPO Alfa treatment early, at the time of inclusion in the study, compared to starting it later, when the patient reaches a certain threshold for needing RBC transfusions. EPO Alfa works by stimulating the production of red blood cells, which can help reduce the need for transfusions in these patients.

What is already known about the treatment

Epoetin Alfa – Epoetin Alfa is administered via injection, typically under the skin or into a vein. It is currently used in medical practice and literature for treating anemia, particularly in patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) who are not dependent on red blood cell transfusions. The main therapeutic indication is to manage anemia in these patients, helping to delay the need for transfusions. At the molecular level, Epoetin Alfa works by stimulating the bone marrow to produce more red blood cells, mimicking the action of the natural hormone erythropoietin. It is classified pharmacologically as an erythropoiesis-stimulating agent.

Investigated diseases

Myelodysplastic Syndromes (MDS) – Myelodysplastic syndromes are a group of disorders caused by poorly formed or dysfunctional blood cells. In MDS, the bone marrow does not produce enough healthy blood cells, leading to anemia, infections, or bleeding. The disease progresses as the bone marrow becomes less effective at producing blood cells, resulting in a higher risk of developing acute myeloid leukemia. Patients may experience fatigue, weakness, and other symptoms related to low blood cell counts. MDS is classified based on the risk of progression to leukemia and the severity of blood cell abnormalities. The condition is more common in older adults and can vary widely in its course and symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515356-21-00Protocol codeGFM-EPO-PRETAREstimated enrolment124 patientsSponsorGroupe Francophone Des Myelodysplasies

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).