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Trial record 1 of 1 for:    pretar | France
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A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS (EPO-PRETAR)

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ClinicalTrials.gov Identifier: NCT03223961
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : February 5, 2018
Sponsor:
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
Drug: EPREX
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).
Drug: EPREX
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03223961


Contacts
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Contact: Sophie Park, Prof +33 (0)4 76 76 62 77 spark@chu-grenoble.fr
Contact: Fatiha Chermat, CRA +33 (0)1 71 20 70 59 fatiha.chermat-ext@aphp.fr

Locations
Show Show 28 study locations
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Investigators
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Principal Investigator: Sophie Park, Prof University Hospital, Grenoble

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Responsible Party: Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier: NCT03223961    
Other Study ID Numbers: GFM-EPO-PRETAR
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: February 5, 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
erythropoetin
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Epoetin Alfa
Hematinics