Azacitidine, Darbepoetin Alfa, and Erythropoietin and Filgastrim (G-CSF) in Treating Patients With Myelodysplastic Syndromes
Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Leukemia focused on measuring 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
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)
Sites / Locations
- Wake Forest University Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Azacitadine and Hematopoietic Growth Factors
Combination of Azacitadine andHematopoietic Growth Factors