Phase I Using Velcade & Idarubicin in Elderly and Relapsed AML

Phase 1 Completed 55 enrolled University of Kentucky National Institutes of Health (NIH) · collab

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2004-02
Primary completion: 2008-10
Completion: 2008-10

Publications

Howard DS, Liesveld J, Phillips GL 2nd, Hayslip J, Weiss H, Jordan CT, Guzman ML. A phase I study using bortezomib with weekly idarubicin for treatment of elderly patients with acute myeloid leukemia. Leuk Res. 2013 Nov;37(11):1502-8. doi: 10.1016/j.leukres.2013.09.003. Epub 2013 Sep 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	0.8 mg/m2	Intravenous
Subject	Bortezomib	Small molecule	1 mg/m2	Intravenous
Subject	Bortezomib	Small molecule	1.2 mg/m2	Intravenous
Subject	Idarubicin	Small molecule	8 mg/m2	Intravenous
Subject	Idarubicin	Small molecule	10 mg/m2	Intravenous
Subject	Idarubicin	Small molecule	12 mg/m2	Intravenous

Phase I Using Velcade & Idarubicin in Elderly and Relapsed AML

Summary

Timeline

Publications

Drugs

Indications