A Trial Testing Early Vs Late Onset of EPO Alfa Treatment in Lower Risk MDS (EPO-PRETAR)

March 6, 2025 updated by: Groupe Francophone des Myelodysplasies

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • CHU Amiens
      • Angers, France, 49 000
        • CH Angers
      • Avignon, France, 84000
        • Ch Avignon
      • Bayonne, France, 64100
        • Centre Hospitalier de la Cote Basque
      • Belfort, France, 90015
        • Hôpital Nord Franche-Comté
      • Besançon, France, 25030
        • CHU de Besançon
      • Bobigny, France, 9300
        • Hôpital Avicenne
      • Brest, France, 29609
        • Hopital Morvan
      • Caen, France, 14033
        • CHU de Caen
      • Cesson, France, 35510
        • CH de Sevigné
      • Cholet, France, 49325
        • CH de Cholet
      • Clermont-Ferrand, France, 63000
        • Chu Estaing
      • Corbeil-Essonnes, France, 91100
        • CHSF Gilles de Corbeil
      • Créteil, France, 94010
        • Hôpital Henri-Mondor
      • Grenoble, France, 38043
        • CHU de Grenoble
      • Le Mans, France, 72000
        • Clinique Victor Hugo
      • Le Mans cedex, France, 72000
        • Centre Hospitalier du Mans
      • Lille, France, 59160
        • Hôpital Saint-Vincent de Paul
      • Limoges, France, 87042
        • CHRU Limoges
      • Lyon, France, 69495
        • Centre Hospitalier Lyon Sud
      • Marseille, France, 13273
        • IPC
      • Mont-de-Marsan, France, 40000
        • Centre Hospitalier du Mont de Marsan
      • Nantes, France, 44093
        • CHU de Nantes
      • Nice, France
        • CHU de Nice
      • Paris, France, 75475
        • Hopital St Louis T4
      • Perpignan, France, 66046
        • Centre Hospitalier Joffre-Perpignan
      • Pessac, France, 33604
        • Sophie Dimicoli-Salazar
      • Poitiers, France, 86021
        • Chu de Poitiers
      • Pringy, France, 74374
        • CHR d'Annecy
      • Périgueux, France, 24019
        • CH de Périgueux
      • Reims, France, 51092
        • CHRU de Reims
      • Rennes, France, 35033
        • CHU Pontchaillou
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint-Nazaire, France, 44600
        • CH Saint Nazaire
      • Strasbourg, France, 67098
        • Centre Hospitalier Universitaire de Strasbourg
      • Toulouse, France, 31059
        • IUCT Oncopole
      • Troyes, France, 10003
        • CH de Troyes
      • Valence, France, 26953
        • CH Valence
      • Vandœuvre-lès-Nancy, France, 54511
        • Chu Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. MDS according to WHO 2016 criteria, with low or int 1 classical IPSS
  3. Non-RBC transfusion dependent anemia
  4. Hb level between 9 and 10.5g/dl (at the center's lab)
  5. 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)
  6. Serum EPO level <500U/l
  7. No other cause of anemia (including iron deficiency, vitamin B12 or B9 deficiency, hemolysis, hypothyroidism….)
  8. Performance status <=2

Exclusion Criteria:

  1. Higher risk MDS (IPSS intermediate-2 or high)
  2. Del 5q
  3. Baseline Hemoglobin level > 10.5 g/dl or <9g/dl
  4. Transfusion threshold (based on age , comorbidities…) >9g/dl
  5. Transfusion threshold less than 1 g/dl below baseline Hb level
  6. RBC transfusion dependence. Patients may have received only one transfusion series for MDS prior to inclusion
  7. CMML , if >10 % BM blasts or WBC>13.000/mm3
  8. Uncontrolled hypertension
  9. Uncontrolled cardiovascular disease including angina pectoris or cardiac failure
  10. Renal failure: Creatinine clearance<40ml/min (using MDRD formula)
  11. Pregnancy (positive bettaHCG) or nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early onset arm
Intervention: early onset of Eprex60000 IU/week , at patient inclusion
Drug: EPREX
60 000 U/week for at least 12 weeks
Other Names:
  • Epoetin alfa
Experimental: Delayed onset arm
Intervention: late introduction of Eprex60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia).
Drug: EPREX
60 000 U/week for at least 12 weeks
Other Names:
  • Epoetin alfa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Erythroid response (according to IWG 2006 criteria)
Time Frame: 12 weeks
Erythroid response (according to IWG 2006 criteria) after 12 weeks of EPO ALFA treatment
12 weeks
response duration to EPO ALFA
Time Frame: 4 years
response duration to EPO ALFA measured from the date of enrollment until failure
4 years
Overall survival
Time Frame: 4 years
Overall survival measured from the date of enrollment to death or the date of last contact
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Groupe Francophone des Myelodysplasies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sophie Park, Prof, University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GFM-EPO-PRETAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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