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

December 1, 2020 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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

124

Phase

  • 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 Backup

Study Locations

  • France
      • Amiens, France
        • Not yet recruiting
        • CHU Amiens
        • Contact:
        • Principal Investigator:
          • Berengere Gruson, MD
      • Angers, France, 49 000
        • Not yet recruiting
        • CH Angers
        • Contact:
        • Principal Investigator:
          • Sylvain Tepot, MD
      • Avignon, France, 84000
        • Not yet recruiting
        • Ch Avignon
        • Contact:
        • Principal Investigator:
          • Bohrane Slama, MD
      • Bayonne, France, 64100
        • Not yet recruiting
        • Centre Hospitalier de la Côte Basque
        • Principal Investigator:
          • Anne Banos, MD
        • Contact:
      • Belfort, France, 90015
        • Not yet recruiting
        • Hôpital Nord Franche-Comté
        • Contact:
        • Principal Investigator:
          • Elena-Catalina ENACHE, MD
      • Besançon, France, 25030
        • Not yet recruiting
        • CHU de Besancon
        • Contact:
        • Principal Investigator:
          • Ana BERCEANU, MD
      • Bobigny, France, 9300
        • Not yet recruiting
        • Hôpital Avicenne
        • Contact:
      • Brest, France, 29609
        • Not yet recruiting
        • Hopital Morvan
        • Contact:
        • Principal Investigator:
          • Christian Berthou, Prof
      • Caen, France, 14033
        • Not yet recruiting
        • CHU de Caen
        • Principal Investigator:
          • Stéphane CHEZE, MD
        • Contact:
      • Cesson, France, 35510
        • Not yet recruiting
        • CH de Sevigné
        • Contact:
        • Principal Investigator:
          • Anne Violaine DONCKER, MD
      • Cholet, France, 49325
        • Not yet recruiting
        • CH de Cholet
        • Contact:
        • Principal Investigator:
          • Anaise BLOUET, MD
      • Clermont-Ferrand, France, 63000
        • Not yet recruiting
        • CHU Estaing
        • Contact:
        • Principal Investigator:
          • Benoit DE RENZIS, MD
      • Corbeil-Essonnes, France, 91100
        • Not yet recruiting
        • CHSF Gilles de Corbeil
        • Principal Investigator:
          • Célia SALANOUBAT, MD
        • Contact:
      • Créteil, France, 94010
        • Not yet recruiting
        • Hopital Henri-Mondor
        • Contact:
        • Principal Investigator:
          • Andrea TOMA, MD
      • Grenoble, France, 38043
        • Not yet recruiting
        • CHU de Grenoble
        • Contact:
        • Principal Investigator:
          • Sophie Park, MD, PHD
      • Le Mans, France, 72000
        • Recruiting
        • Clinique Victor Hugo
        • Principal Investigator:
          • Katell LE DU, MD
        • Contact:
      • Le Mans cedex, France, 72000
        • Not yet recruiting
        • Centre Hospitalier Du Mans
        • Principal Investigator:
          • Kamel LARIBI, MD
        • Contact:
      • Lille, France, 59160
        • Not yet recruiting
        • Hôpital Saint-Vincent de Paul
        • Contact:
        • Principal Investigator:
          • Christian ROSE, prof
      • Limoges, France, 87042
      • Lyon, France, 69495
        • Not yet recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
        • Principal Investigator:
          • Eric Wattel, MD, PHD
      • Marseille, France, 13273
        • Not yet recruiting
        • IPC
        • Contact:
        • Principal Investigator:
          • Norbert Vey, prof
      • Mont-de-Marsan, France, 40000
        • Not yet recruiting
        • Centre Hospitalier du Mont de Marsan
        • Contact:
        • Principal Investigator:
          • REZA TABREZI, MD
      • Nantes, France, 44093
        • Not yet recruiting
        • CHU de Nantes
        • Principal Investigator:
          • Pierre Peterlin, MD
        • Contact:
      • Nice, France
        • Not yet recruiting
        • CHU de Nice
        • Contact:
        • Principal Investigator:
          • Thomas Cluzeau, MD
      • Paris, France, 75475
        • Not yet recruiting
        • Hopital St Louis T4
        • Contact:
        • Principal Investigator:
          • Pierre Fenaux, prof
      • Perpignan, France, 66046
        • Not yet recruiting
        • Centre Hospitalier Joffre-Perpignan
        • Principal Investigator:
          • Laurence SANHES, MD
        • Contact:
      • Pessac, France, 33604
      • Poitiers, France, 86021
        • Not yet recruiting
        • CHU de Poitiers
        • Principal Investigator:
          • Jose Miguel TORREGROSA DIAZ, MD
        • Contact:
      • Pringy, France, 74374
        • Recruiting
        • CHR d'Annecy
        • Contact:
        • Principal Investigator:
          • Pascale Cony-Makhoul, MD
      • Périgueux, France, 24019
        • Not yet recruiting
        • CH de Périgueux
        • Contact:
          • Marius MOLDOVAN, MD
          • Phone Number: 0553452585
        • Principal Investigator:
          • Marius MOLDOVAN, MD
      • Reims, France, 51092
        • Not yet recruiting
        • CHRU de Reims
        • Contact:
        • Principal Investigator:
          • Chantal HIMBERLIN, MD
      • Rennes, France, 35033
        • Not yet recruiting
        • CHU Pontchaillou
        • Contact:
        • Principal Investigator:
          • Stanislas NIMUBONA, MD
      • Rouen, France, 76038
      • Saint-Nazaire, France, 44600
        • Not yet recruiting
        • CH Saint Nazaire
        • Principal Investigator:
          • Elsa LESTANG, MD
        • Contact:
      • Strasbourg, France, 67098
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Strasbourg
        • Contact:
        • Principal Investigator:
          • Shanti NATAJARAN-AME, MD
      • Toulouse, France, 31059
        • Not yet recruiting
        • IUCT Oncopole
        • Contact:
        • Principal Investigator:
          • Odile BEYNE-RAUZY, Prof
      • Troyes, France, 10003
        • Recruiting
        • CH de Troyes
        • Contact:
        • Principal Investigator:
          • Nadia ALI AMAR, MD
      • Valence, France, 26953
        • Recruiting
        • Ch Valence
        • Contact:
        • Principal Investigator:
          • Jixing LIU, MD
      • Vandœuvre-lès-Nancy, France, 54511
        • Not yet recruiting
        • CHU Brabois
        • Contact:

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
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

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

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

Groupe Francophone des Myelodysplasies

Investigators

  • 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)

March 26, 2018

Primary Completion (Anticipated)

May 16, 2022

Study Completion (Anticipated)

May 16, 2024

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 18, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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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