Spots Global Cancer Trial Database for A Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS

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)

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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial