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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03223961
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : February 2, 2018
Information provided by (Responsible Party):
Groupe Francophone des Myelodysplasies

Brief 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)

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: EPREX Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomazed study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2021

Arm Intervention/treatment
Experimental: Early onset arm
Intervention: early onset of Eprex60000 IU/week , at patient inclusion
60 000 U/week for at least 12 weeks
Other Name: 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).
60 000 U/week for at least 12 weeks
Other Name: Epoetin alfa

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. response duration to EPO ALFA [ Time Frame: 4 years ]
    response duration to EPO ALFA measured from the date of enrollment until failure

  3. Overall survival [ Time Frame: 4 years ]
    Overall survival measured from the date of enrollment to death or the date of last contact

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03223961

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Contact: Sophie Park, Prof +33 (0)4 76 76 62 77
Contact: Fatiha Chermat, CRA +33 (0)1 71 20 70 59

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Chu Amiens Not yet recruiting
Amiens, France
Contact: Berengere gruson, MD    +33322455985   
Principal Investigator: Berengere Gruson, MD         
CH Angers Not yet recruiting
Angers, France, 49 000
Contact: Sylvain THEPOT    +33 2 41 35 44 66   
Principal Investigator: Sylvain Tepot, MD         
CH Avignon Not yet recruiting
Avignon, France, 84000
Contact: Bohrane Slama, MD    0432753132   
Principal Investigator: Bohrane Slama, MD         
Centre Hospitalier de La Cote Basque Not yet recruiting
Bayonne, France, 64100
Contact: Anne Banos, MD    033559443832   
Principal Investigator: Anne Banos, MD         
Hopital Avicenne Not yet recruiting
Bobigny, France, 9300
Contact: Thorsten Braun, MD    +33148957057   
Principal Investigator: Thorsten Braun, MD         
Hôpital Morvan Not yet recruiting
Brest, France, 29609
Contact: Christian Berthou, Prof    +33298223504   
Principal Investigator: Christian Berthou, Prof         
CHU de Caen Not yet recruiting
Caen, France, 14033
Contact: Stéphane Cheze, MD    +33231272360   
Principal Investigator: Stéphane Cheze, MD         
CHU Estaing Not yet recruiting
Clermont-Ferrand, France, 63000
Contact: Benoit De RENZIS, MD    +33 4 73 75 00 66   
Principal Investigator: Benoit De RENZIS, MD         
CHSF Gilles de Corbeil Not yet recruiting
Corbeil-Essonnes, France, 91100
Contact: Célia Salanoubat, MD    +33160903178   
Principal Investigator: Célia Salanoubat, MD         
CHU de Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Sophie Park, MD, PHD    +33 4 76 76 62 77   
Principal Investigator: Sophie Park, MD, PHD         
Centre Hospitalier du Mans Not yet recruiting
Le Mans cedex, France, 72000
Contact: Kamel Laribi, MD    +33243434361   
Principal Investigator: Kamel Laribi, MD         
Hopital Saint-Vincent de Paul Not yet recruiting
Lille, France, 59160
Contact: Christian Rose, MD    +33 20874532   
Principal Investigator: Christian Rose, Prof         
CHRU Limoges Not yet recruiting
Limoges, France, 87042
Contact: Marie-Pierre Gourin, MD    +33555056642   
Principal Investigator: Marie-Pierre Gourin, MD         
Centre Hospitalier Lyon Sud Not yet recruiting
Lyon, France, 69495
Contact: Eric Wattel, MD, PHD    +33 4 72 11 74 01   
Principal Investigator: Eric Wattel, MD, PHD         
IPC Not yet recruiting
Marseille, France, 13273
Contact: Norbert Vey, prof    033 4 91 22 36 67   
Principal Investigator: Norbert Vey, prof         
CHU de Nantes Not yet recruiting
Nantes, France, 44093
Contact: Pierre Peterlin, MD    +33 2 40 08 32 77   
Principal Investigator: Pierre Peterlin, MD         
CHU de Nice Not yet recruiting
Nice, France
Contact: Thomas Cluzeau, MD    +33492035844   
Principal Investigator: Thomas Cluzeau, MD         
Hopital St Louis T4 Not yet recruiting
Paris, France, 75475
Contact: Pierre Fenaux, PHD    +33 171207018   
Principal Investigator: Pierre Fenaux, prof         
Centre Hospitalier Joffre-Perpignan Not yet recruiting
Perpignan, France, 66046
Contact: Laurence Sanhes, MD    +33468616448   
Principal Investigator: Laurence Sanhes, MD         
Sophie Dimicoli-Salazar Not yet recruiting
Pessac, France, 33604
Contact: Sophie Dimicoli-Salazar, MD    +33557656511   
Principal Investigator: Sophie Dimicoli-Salazar, MD         
CHU de Poitiers Not yet recruiting
Poitiers, France, 86021
Contact: Jose Miguel Torregrosa Diaz, MD    +33 5 48 44 30 29   
Principal Investigator: Jose Miguel Torregrosa Diaz, MD         
CHR d'Annecy Recruiting
Pringy, France, 74374
Contact: Pascale Cony-Makhoul, MD    +33450636608   
Principal Investigator: Pascale Cony-Makhoul, MD         
CHRU de Reims Not yet recruiting
Reims, France, 51092
Contact: Chantal HIMBERLIN, MD    003326783644   
Principal Investigator: Chantal HIMBERLIN, MD         
CHU Pontchaillou Not yet recruiting
Rennes, France, 35033
Contact: Stanislas Nimubona, MD    33299289521   
Principal Investigator: Stanislas Nimubona, MD         
Centre Henri Becquerel Not yet recruiting
Rouen, France, 76038
Contact: Aspasia Stamatoulas, MD    +33 232082288   
Principal Investigator: Aspasia Stamatoullas, MD         
Centre Hospitalier Universitaire de STRASBOURG Not yet recruiting
Strasbourg, France, 67098
Contact: Shanti NATAJARAN-AME, MD    00 33 3 88 12 76 70   
Principal Investigator: Shanti NATAJARAN-AME, MD         
IUCT Oncopole Not yet recruiting
Toulouse, France, 31059
Contact: Odile Beyne-Rauzy, Prof    +33531156264   
Principal Investigator: Odile Beyne-Rauzy, Prof         
CHU Brabois Not yet recruiting
Vandœuvre-lès-Nancy, France, 54511
Contact: Agnès Guerci-Bresler, MD    +33383153281   
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
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Principal Investigator: Sophie Park, Prof University Hospital, Grenoble

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Responsible Party: Groupe Francophone des Myelodysplasies Identifier: NCT03223961     History of Changes
Other Study ID Numbers: GFM-EPO-PRETAR
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Francophone des Myelodysplasies:
myelodysplastic syndrome
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Epoetin Alfa