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Phase III Evaluation of EPO With or Without G-CSF Versus Supportive Therapy Alone in the Treatment of Myelodysplastic Syndromes
RATIONALE: Erythropoietin and colony-stimulating factors such as filgrastim stimulate the production of blood cells. It is not yet known whether erythropoietin with or without filgrastim is more effective than standard blood transfusions in reducing the need for transfusions in patients who have anemia associated with myelodysplastic syndrome. PURPOSE: Randomized phase III trial to compare the effectiveness of erythropoietin with or without filgrastim with that of standard blood transfusions in reducing the need for transfusions in patients who have anemia associated with myelodysplastic syndrome.
Details
| Lead sponsor | Eastern Cooperative Oncology Group |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 118 |
| Start date | 1998-03-04 |
| Completion | 2014-05 |
Conditions
- Anemia
- Myelodysplastic Syndromes
Interventions
- Erythropoietin
- Filgrastim
- Transfusion
Primary outcomes
- Proportion of Patients Free of Transfusion at 4 Months — Assessed at 4 months
Whether a patient required transfusion or not at 4 months was recorded.
Countries
United States