Myelodysplastic SyndromesPhase 3EPO-PRETARNCT03223961
A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS
A Phase 3 study testing EPREX in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 39 sites in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- EPREX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 39 sitesFrance
- Study dates
- 26 Mar 2018to 1 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- MDS according to WHO 2016 criteria, with low or int 1 classical IPSS
- Non-RBC transfusion dependent anemia
- Hb level between 9 and 10.5g/dl (at the center's lab)
- 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)
- Serum EPO level <500U/l
- No other cause of anemia (including iron deficiency, vitamin B12 or B9 deficiency, hemolysis, hypothyroidism….)
- Performance status <=2
Who cannot join
- Higher risk MDS (IPSS intermediate-2 or high)
- Del 5q
- Baseline Hemoglobin level > 10.5 g/dl or <9g/dl
- Transfusion threshold (based on age , comorbidities…) >9g/dl
- Transfusion threshold less than 1 g/dl below baseline Hb level
- RBC transfusion dependence. Patients may have received only one transfusion series for MDS prior to inclusion
Show all 11Show fewer
- CMML , if >10 % BM blasts or WBC>13.000/mm3
- Uncontrolled hypertension
- Uncontrolled cardiovascular disease including angina pectoris or cardiac failure
- Renal failure: Creatinine clearance<40ml/min (using MDRD formula)
- Pregnancy (positive bettaHCG) or nursing
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
France39 sites
Chu Amiens
Amiens
CH Angers
Angers, 49 000
CH Avignon
Avignon, 84000
Centre Hospitalier de La Cote Basque
Bayonne, 64100
Hopital Nord Franche-Comté
Belfort, 90015
CHU de Besançon
Besançon, 25030
Hopital Avicenne
Bobigny, 9300
Hôpital Morvan
Brest, 29609
CHU de Caen
Caen, 14033
CH de Sevigné
Cesson, 35510
CH de Cholet
Cholet, 49325
CHU Estaing
Clermont-Ferrand, 63000
CHSF Gilles de Corbeil
Corbeil-Essonnes, 91100
Hôpital Henri-Mondor
Créteil, 94010
CHU de Grenoble
Grenoble, 38043
Centre Hospitalier du Mans
Le Mans, 72000
Clinique Victor Hugo
Le Mans, 72000
Hopital Saint-Vincent de Paul
Lille, 59160
CHRU Limoges
Limoges, 87042
Centre Hospitalier Lyon Sud
Lyon, 69495
IPC
Marseille, 13273
Centre Hospitalier du Mont de Marsan
Mont-de-Marsan, 40000
CHU de Nantes
Nantes, 44093
CHU de Nice
Nice
Hopital St Louis T4
Paris, 75475
CH de Périgueux
Périgueux, 24019
Centre Hospitalier Joffre-Perpignan
Perpignan, 66046
Sophie Dimicoli-Salazar
Pessac, 33604
CHU de Poitiers
Poitiers, 86021
CHR d'Annecy
Pringy, 74374
CHRU de Reims
Reims, 51092
CHU Pontchaillou
Rennes, 35033
Centre Henri Becquerel
Rouen, 76038
CH Saint Nazaire
Saint-Nazaire, 44600
Centre Hospitalier Universitaire de STRASBOURG
Strasbourg, 67098
IUCT Oncopole
Toulouse, 31059
CH de Troyes
Troyes, 10003
CH Valence
Valence, 26953
CHU Brabois
Vandœuvre-lès-Nancy, 54511
About this study
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
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)
Read the 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
- Early onset arm: early onset of EPO ALFA 60000 IU/week , at patient inclusion
- 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
- Myelodysplastic Syndromes
- Being tested
- EPREX
- Keywords
- myelodysplastic syndrome, erythropoetin
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPREXDrug
Also called Epoetin alfa
60 000 U/week for at least 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Early onset arm | Experimental | Intervention: early onset of Eprex60000 IU/week , at patient inclusion Receives: Drug: EPREX |
| Delayed onset arm | Experimental | Intervention: late introduction of Eprex60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia). Receives: Drug: EPREX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to RBC transfusion dependence in non RBC transfusion dependent lower risk MDS patients with anemia with early (at inclusion of the patient) versus delayed onset,( at the threshold chosen for RBC transfusion) of EPO ALFA
RBC transfusion dependence will be defined by requirement of at least transfusions of 2 PRBC within an interval of less than 8 weeks, given for Hb <8g/dl or <9g/dl according to comorbidities and in the absence of other cause of anemia (bleeding, surgery…), taking into account only transfusions given at least 12 weeks after onset of treatment with EPO ALFA.
Measured: 12 weeks
Secondary outcomes (3)
Erythroid response (according to IWG 2006 criteria)
Erythroid response (according to IWG 2006 criteria) after 12 weeks of EPO ALFA treatment
Measured: 12 weeks
response duration to EPO ALFA
response duration to EPO ALFA measured from the date of enrollment until failure
Measured: 4 years
Overall survival
Overall survival measured from the date of enrollment to death or the date of last contact
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start26 Mar 2018
- Primary completion21 Sep 2023
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- randomazed study
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Francophone des Myelodysplasies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Park, Prof, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223961
- Sponsor's protocol ID
- GFM-EPO-PRETAR
- Acronym
- EPO-PRETAR
- Status last verified
- Sep 2026
- First submitted
- 11 Jul 2017
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03223961
- Acronym / sponsor ID
- EPO-PRETAR / GFM-EPO-PRETAR
- Conditions
- Myelodysplastic Syndromes
- Keywords
- myelodysplastic syndrome, erythropoetin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Groupe Francophone des MyelodysplasiesUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Early onset arm: early onset of EPO ALFA 60000 IU/week , at patient inclusion
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomazed study
| Arm | Type | Receives |
|---|---|---|
| Early onset arm | Experimental | Drug: EPREXIntervention: early onset of Eprex60000 IU/week , at patient inclusion |
| Delayed onset arm | Experimental | Drug: EPREXIntervention: late introduction of Eprex60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- MDS according to WHO 2016 criteria, with low or int 1 classical IPSS
- Non-RBC transfusion dependent anemia
- Hb level between 9 and 10.5g/dl (at the center's lab)
- 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)
Key exclusion criteria (11 listed)
- Higher risk MDS (IPSS intermediate-2 or high)
- Del 5q
- Baseline Hemoglobin level > 10.5 g/dl or <9g/dl
- Transfusion threshold (based on age , comorbidities…) >9g/dl
- Transfusion threshold less than 1 g/dl below baseline Hb level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPREXAlso: Epoetin alfa60 000 U/week for at least 12 weeks | Drug | Delayed onset arm, Early onset arm |
Primary outcome
Time to RBC transfusion dependence in non RBC transfusion dependent lower risk MDS patients with anemia with early (at inclusion of the patient) versus delayed onset,( at the threshold chosen for RBC transfusion) of EPO ALFA
Time frame: 12 weeks
RBC transfusion dependence will be defined by requirement of at least transfusions of 2 PRBC within an interval of less than 8 weeks, given for Hb <8g/dl or <9g/dl according to comorbidities and in the absence of other cause of anemia (bleeding, surgery…), taking into account only transfusions given at least 12 weeks after onset of treatment with EPO ALFA.
3 secondary outcomes
Erythroid response (according to IWG 2006 criteria)
Time frame: 12 weeks
response duration to EPO ALFA
Time frame: 4 years
Overall survival
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Myelodysplastic Syndromes
RecruitingPhase 2
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
Severe Aplastic Anemia, MDS (Myelodysplastic Syndrome)
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
RecruitingPhase 2
Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)
Myelodysplastic Syndrome
Enrolling by invitationPhase 1
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring
Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie Park, Prof principal investigator
University Hospital, Grenoble
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EPREX in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 39 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to RBC transfusion dependence in non RBC transfusion dependent lower risk MDS patients with anemia with early (at inclusion of the patient) versus delayed onset,( at the threshold chosen for RBC transfusion) of EPO ALFA (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.