Azacitidine, Darbepoetin Alfa, and Erythropoietin and Filgastrim (G-CSF) in Treating Patients With Myelodysplastic Syndromes

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Nov 9, 2006

Keywords

ClinConnect Summary

OBJECTIVES:

Primary

* Determine the hematological response rate in patients with myelodysplastic syndromes treated with azacitidine, darbepoetin alfa, and filgrastim (G-CSF).

Secondary

* Determine the time to leukemia progression, survival, and changes in apoptotic index of bone marrow in patients treated with this regimen.

OUTLINE: This is an open-label, nonrandomized study.

* Initial therapy (courses 1 and 2): Patients receive azacitidine subcutaneously (SC) or intra-venous (IV) on days 1-5 (week 1) and darbepoetin alfa\* SC on day 8 (week 2). Treatment repeats every 28 days for 2 c...

Gender

ALL

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)