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

NCT03223961

Description:

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)

Related Conditions:
  • Myelodysplastic Syndromes
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GFM-EPO-PRETAR
  • NCT ID: NCT03223961

Conditions

  • Myelodysplastic Syndromes

Interventions

DrugSynonymsArms
EPREXEpoetin alfaEarly onset arm

Purpose

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)

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).
    

Trial Arms

NameTypeDescriptionInterventions
Early onset armExperimentalIntervention: early onset of Eprex60000 IU/week , at patient inclusion
  • EPREX
Delayed onset armExperimentalIntervention: late introduction of Eprex60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia).
  • EPREX

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description: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

Measure:Erythroid response (according to IWG 2006 criteria)
Time Frame:12 weeks
Safety Issue:
Description:Erythroid response (according to IWG 2006 criteria) after 12 weeks of EPO ALFA treatment
Measure:response duration to EPO ALFA
Time Frame:4 years
Safety Issue:
Description:response duration to EPO ALFA measured from the date of enrollment until failure
Measure:Overall survival
Time Frame:4 years
Safety Issue:
Description:Overall survival measured from the date of enrollment to death or the date of last contact

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Groupe Francophone des Myelodysplasies

Trial Keywords

  • myelodysplastic syndrome
  • erythropoetin

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