Azacitidine, Darbepoetin Alfa, and Erythropoietin and Filgastrim (G-CSF) in Treating Patients With Myelodysplastic Syndromes
Condition: Leukemia; Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Azacitadine and Hematopoietic Growth Factors
Intervention description: Combination of Azacitadine and Hematopoietic Growth Factors
Intervention MeSH terms: Mitogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Maximum age: 120 Years
Healthy volunteers: No
Keywords: de novo myelodysplastic syndromes; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia; refractory cytopenia with multilineage dysplasia; chronic myelomonocytic leukemia; secondary myelodysplastic syndromes; childhood myelodysplastic syndromes

Summary:

      RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop
      the growth of abnormal cells, either by killing the cells or by stopping them from dividing.
      Colony-stimulating factors, such as darbepoetin alfa and G-CSF, may increase the number of
      red blood cells and white blood cells found in bone marrow or peripheral blood and may help
      the immune system recover from the side effects of chemotherapy. Giving azacitidine together
      with darbepoetin alfa and G-CSF may be an effective treatment for myelodysplastic syndromes.

      PURPOSE: This clinical trial is studying how well giving azacitidine together with
      darbepoetin alfa and G-CSF works in treating patients with myelodysplastic syndromes.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of myelodysplastic syndromes (MDS)

               -  Bone marrow aspirate and biopsy with karyotyping performed within the past 8
                  weeks

          -  Patients with chronic myelomonocytic leukemia (CMML), refractory anemia (RA), or
             refractory anemia with ringed sideroblasts (RARS) according to FAB classification OR
             RA, RARS, refractory anemia with multilineage dysplasia, or RARS with multilineage
             dysplasia according to WHO classification must meet ≥ 1 of the following criteria:

               -  Symptomatic anemia requiring RBC transfusion for ≥ 3 months before study entry

               -  Thrombocytopenia with ≥ 2 platelet counts < 50,000/mm³ OR a significant
                  hemorrhage requiring platelet transfusion

               -  Neutropenia with an absolute neutrophil count < 1,000/mm³ and an infection
                  requiring IV antibiotics

          -  No refractory anemia with excess blasts in transformation

          -  No history of leukemia

          -  No known primary or metastatic hepatic tumor

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy > 2 months

          -  AST and ALT ≤ 2 times upper limit of normal

          -  Creatinine < 2.0 mg/dL

          -  Serum vitamin B12 normal

          -  Serum and/or red cell folate levels normal

          -  Ferritin ≥ 50 ng/mL

          -  Copper > 40 µg/dL

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  Negative pregnancy test

        PRIOR CONCURRENT THERAPY:

          -  No prior azacitidine or decitabine

          -  No prior therapy for MDS

               -  Supportive therapy within the past 28 days allowed

          -  No other concurrent treatment for MDS (i.e., thalidomide, arsenic trioxide,
             cyclosporine, or melphalan)

          -  No other concurrent hematopoietic growth factors, including epoetin alfa, filgrastim
             (G-CSF), sargramostim (GM-CSF), or interleukin-11 (oprelvekin)