University of Iowa Hospitals and Clinics

Clinical Trial Details

Short Title
Official Title
A Phase III Randomized Trial for Patients with de novo AML using Bortezomib and Sorafenib (IND#114480; NSC# 681239, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD
Description

A Phase III Randomized Trial for Patients with de novo AML using Bortezomib and Sorafenib (IND#114480; NSC# 681239, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD

AML is a cancer of the bone marrow, the spongy tissue inside the large bones of the body where blood cells are made. In AML, the bone marrow makes large numbers of immature white blood cells called blasts. These blast cells crowd out the normal cells of the bone marrow. They may also invade body organs including the brain, testes, ovaries, or skin. These cancerous AML cells can sometimes form a solid tumor called a chloroma.

The main goals of this study are:

For subjects without high amounts of the FLT3 gene mutation,

1.  To see if an investigational drug, called bortezomib, is tolerated when added to the standard AML treatment without causing too many serious side effects.

2. To compare the effects, good and/or bad, of adding bortezomib to the standard AML treatment to find out which is better. In this study, you will get either the standard treatment plus bortezomib or the standard treatment alone.

For subjects with high amounts of the FLT3 gene mutation,

3. To determine the dose of sorafenib that can be safely given with the standard AML treatment.

4. To compare the effects, good and/or bad, of adding sorafenib to standard AML treatment to find out which is better.

5. To determine how effective the combination of sorafenib and chemotherapy will be at killing cancer cells.

Approximately 5 people will take part in this study conducted by investigators at the University of Iowa. The total number of people enrolled on this study nationally is expected to be 1250.

Start Date
June 20, 2011
End Date
June 20, 2016
Gender Preference
None
Age Group
0 - 29 years
Principal Investigator
Ayman El-Sheikh, MD
Contact Info

Julie de la Garza, (319) 356-3749

Department
Keywords
acute myeloid leukemia (AML) ; bortezomib ; cancer ; children ; pediatric ; phase III ; sorafenib ;

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