Myelodysplastic Syndromes Clinical Trial
Official title:
A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes (MDS)
The purpose of this study is to determine whether patients with high-risk myelodysplastic
syndromes (MDS) treated with azacitidine have improved survival compared to conventional care
treatments. The study will also assess the effect of treatments on response, duration of
response, and transformation to acute myeloid leukemia (AML). The study will continue for 12
months following last patient enrolled.
See study AZA PH GL 2003 CL 001 E for information about the extension to this study.
Comparison/Control Interventions offered the physician three options:
- Best supportive care (BSC) alone,
- Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days, or
- Standard chemotherapy administered for induction as a continuous intravenous infusion of
cytarabine over 7 days plus an anthracycline (daunorubicin, idarubicin, or mitoxantrone)
on Days 1, 2, and 3; and, for those eligible, 1 or 2 consolidation cycles administered
as continuous intravenous infusions of cytarabine for 3 to 7 days with the same
anthracycline that was used at induction on Days 1 and 2 (each cycle between 28 to 70
days from the start of the previous cycle).
All three options included best supportive care. Neither the experimental group (azacitidine)
nor any of the comparison/control options allowed use of erythropoietin.
Duration of Intervention: Patients will be treated until death, withdrawal, unacceptable
toxicity or conclusion of the study.
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