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

Sponsor
Groupe Francophone des Myelodysplasies (Other)
Overall Status
Recruiting
CT.gov ID
NCT03223961
Collaborator
(none)
124
39
2
73.7
3.2
0

Study Details

Study Description

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
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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomazed studyrandomazed 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 :
Mar 26, 2018
Anticipated Primary Completion Date :
May 16, 2022
Anticipated Study Completion Date :
May 16, 2024

Arms and Interventions

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
  • Outcome Measures

    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 [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) [12 weeks]

      Erythroid response (according to IWG 2006 criteria) after 12 weeks of EPO ALFA treatment

    2. response duration to EPO ALFA [4 years]

      response duration to EPO ALFA measured from the date of enrollment until failure

    3. Overall survival [4 years]

      Overall survival measured from the date of enrollment to death or the date of last contact

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu Amiens Amiens France
    2 CH Angers Angers France 49 000
    3 CH Avignon Avignon France 84000
    4 Centre Hospitalier de La Cote Basque Bayonne France 64100
    5 Hopital Nord Franche-Comté Belfort France 90015
    6 CHU de Besançon Besançon France 25030
    7 Hopital Avicenne Bobigny France 9300
    8 Hôpital Morvan Brest France 29609
    9 CHU de Caen Caen France 14033
    10 CH de Sevigné Cesson France 35510
    11 CH de Cholet Cholet France 49325
    12 CHU Estaing Clermont-Ferrand France 63000
    13 CHSF Gilles de Corbeil Corbeil-Essonnes France 91100
    14 Hôpital Henri-Mondor Créteil France 94010
    15 CHU de Grenoble Grenoble France 38043
    16 Centre Hospitalier du Mans Le Mans cedex France 72000
    17 Clinique Victor Hugo Le Mans France 72000
    18 Hopital Saint-Vincent de Paul Lille France 59160
    19 CHRU Limoges Limoges France 87042
    20 Centre Hospitalier Lyon Sud Lyon France 69495
    21 IPC Marseille France 13273
    22 Centre Hospitalier du Mont de Marsan Mont-de-Marsan France 40000
    23 CHU de Nantes Nantes France 44093
    24 CHU de Nice Nice France
    25 Hopital St Louis T4 Paris France 75475
    26 Centre Hospitalier Joffre-Perpignan Perpignan France 66046
    27 Sophie Dimicoli-Salazar Pessac France 33604
    28 CHU de Poitiers Poitiers France 86021
    29 CHR d'Annecy Pringy France 74374
    30 CH de Périgueux Périgueux France 24019
    31 CHRU de Reims Reims France 51092
    32 CHU Pontchaillou Rennes France 35033
    33 Centre Henri Becquerel Rouen France 76038
    34 CH Saint Nazaire Saint-Nazaire France 44600
    35 Centre Hospitalier Universitaire de STRASBOURG Strasbourg France 67098
    36 IUCT Oncopole Toulouse France 31059
    37 CH de Troyes Troyes France 10003
    38 CH Valence Valence France 26953
    39 CHU Brabois Vandœuvre-lès-Nancy France 54511

    Sponsors and Collaborators

    • Groupe Francophone des Myelodysplasies

    Investigators

    • Principal Investigator: Sophie Park, Prof, University Hospital, Grenoble

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Francophone des Myelodysplasies
    ClinicalTrials.gov Identifier:
    NCT03223961
    Other Study ID Numbers:
    • GFM-EPO-PRETAR
    First Posted:
    Jul 21, 2017
    Last Update Posted:
    Dec 2, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 2, 2020