At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of myelodysplastic syndrome: refractory anemia (RA), RA with ringed sideroblasts, or RA with excess blasts (RAEB)
- ✓RAEB patients must have bone marrow blast count <20% and <5% blast forms on peripheral blood
- ✓Age at least 18 years
- ✓Platelet count greater than 30,000/mm³ without platelet transfusions
- ✕RAEB in transformation
- ✕Chronic myelomonocytic leukemia
- ✕Splenomegaly greater than 6 cm below left costal margin or greater than 3 times normal size
- ✕Uncontrolled hypertension
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Evaluation of EPO With or Without G-CSF Versus Supportive Therapy Alone in the Treatment of Myelodysplastic Syndromes
In Brief
A Phase 3 clinical trial evaluating Erythropoietin, Filgrastim, and 1 other intervention for Anemia and Myelodysplastic Syndromes. Completed, enrolled 118 participants across 28 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Administered at 150 units/kg subcutaneously every day. Rotating sites should be used. The dose should be rounded off to the nearest 1000 U. The dose should be adjusted based on hematocrit.
G-CSF should start at a dose of 1 mcg/kg per day or 2.5 mcg/kg three times a week subcutaneously. Rotating sites should be used The dose should be rounded off to the nearest 10 mcg.
Red cell and platelet transfusions