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)
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
60 000 U/week for at least 12 weeks
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
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.
Time frame: 12 weeks
Erythroid response (according to IWG 2006 criteria)
Erythroid response (according to IWG 2006 criteria) after 12 weeks of EPO ALFA treatment
Time frame: 12 weeks
response duration to EPO ALFA
response duration to EPO ALFA measured from the date of enrollment until failure
Time frame: 4 years
Overall survival
Overall survival measured from the date of enrollment to death or the date of last contact
Time frame: 4 years
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