NCT00086099

Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Leukemia
• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Idarubincin and Amufostine (Ethyol)	Starting doses of Idarubincin(12,18 mg/m2 to 21 mg/m2), ara-C, plus amofostine (N-36)
DRUG	Idarubincin	Idarubincin (12mg/m2) and ara-C(N-18)

Timeline

• Start date: 2004-07-01
• Primary completion: 2005-12-01
• Completion: 2006-02-01
• First posted: 2004-06-25
• Last updated: 2009-01-29

Locations

19 sites across 2 countries: United States, Israel