NCT00382954

Phase I Using Velcade & Idarubicin in Elderly and Relapsed AML

A Phase I Study Using Bortezomib (Velcade, Formerly Known as PS-341) With Weekly Idarubicin for the Treatment of Elderly (>/= 60 Years) and Relapsed Patients With Acute Myelogenous Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: University of Kentucky · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximal tolerated dose (MTD) of bortezomib and idarubicin given in combination to newly diagnosed AML patients \>60 years or relapsed AML patients. Another purpose of this study is to determine the dose limiting toxicities associated with bortezomib in combination with idarubicin in newly diagnosed AML patients \>60 years or relapsed AML patients.

Conditions

• Acute Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	Velcade	velcade (4 original dosing levels with 3 modified dosing levels) I.V. on days 1, 4, 8, 11, 15, 18, 22, and 25 for 4 weeks concurrent with the Idarubicin
DRUG	Idarubicin	I.V., 8, or 10 or 12 mg/m\^2 weekly (days 1, 8, 15, and 22) for 4 weeks

Timeline

• Start date: 2004-02-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-10-02
• Last updated: 2010-09-29

Locations

2 sites across 1 country: United States