Leukemia Clinical Trial
Official title:
A Phase IB/II, Randomized, Open-Label, Multicenter Study Evaluating Whether the Addition of Amifostine (Ethyol®) Will Enable the Safe Increase in Dose Intensity of Idarubicin in Combination With Cytosine Arabinoside in Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia
The primary objectives of this study are:
1. To evaluate whether the addition of amifostine will allow for the safe administration
of idarubicin at a dose of 21 mg/m² in combination with standard-dose ara-C in older
patients with newly diagnosed, previously untreated acute myeloid leukemia (AML); and
2. To estimate the complete remission rate of induction therapy with amifostine,
idarubicin (21 mg/m²), plus ara-C or induction therapy with idarubicin (12 mg/m²) plus
ara-C in this patient population.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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