Erythropoietin (EPO)+/- Filgrastim (G-CSF) vs. Supportive Therapy Alone for Patients With Myelodysplastic Syndromes
Condition: Anemia; Myelodysplastic Syndromes
MeSH terms: Preleukemia; Anemia; Myelodysplastic Syndromes; Syndrome
Intervention: Erythropoietin; Filgrastim; Transfusion
Intervention description: 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
Intervention MeSH terms: Epoetin Alfa; Lenograstim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; refractory anemia; myelodysplastic syndromes; erythropoietin; filgrastim

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Diagnosis of a myelodysplastic syndrome

          -  Refractory anemia (RA)

          -  RA with ringed sideroblasts

          -  RA with excess blasts (RAEB). RAEB patients must have a bone marrow blast count of
             less than 20% and less than 5% blast forms on peripheral blood

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3

          -  Platelet count greater than 30,000/mm^3 (without platelet transfusions)

          -  Hematocrit less than 30% (pretransfusion)

          -  Bilirubin less than 3 mg/dL

          -  Blood urea nitrogen (BUN) less than 40 mg/dL or Creatinine less than 2.0 mg/dL

          -  Prior epoetin alfa allowed provided dosage was less than 30,000 units per week for
             less than 1 month duration

          -  At least 1 month since prior erythropoietin

          -  At least 2 months since prior recombinant growth factor

          -  At least 2 months since prior chemotherapy for other malignancy or autoimmune disease

          -  At least 2 weeks since prior androgen or steroids for treatment of myelodysplastic
             syndromes

        Exclusion Criteria:

          -  RAEB in transformation

          -  Chronic myelomonocytic leukemia

          -  Splenomegaly greater than 6 cm below the left costal margin or greater than 3 times
             normal size

          -  Uncontrolled hypertension

          -  Sensitivity to E. coli-derived proteins

          -  Sensitivity to epoetin alfa or any of its components (e.g., human albumin)

          -  Documented iron deficiency. If marrow iron stain is not available, the transferrin
             saturation must be greater than 20% or ferritin greater than 100 ng/dL

          -  Active infection or bleeding

          -  Other uncontrolled malignancy

          -  Pregnant or nursing. Fertile patients must use effective contraception.