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

• Status: Recruiting
• Trial end date: 2024-05-16
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Francophone des Myelodysplasies
• Treatments: Epoetin Alfa

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