A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib and Sorafenib

Children's Oncology Group (COG)


Clinical Trial

Offered by: Nemours
Locations: Delaware Valley, Jacksonville, FL, Orlando, FL, Pensacola, FL

Trial Name

A Phase III Randomized Trial for Patients With De Novo AML Using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND# 69896, NSC# 724772)

What is the trial about?

To determine dose of sorafenib that is safe when added to standard AML treatment; to compare the effects of adding sorafenib to standard AML treatment to find out which is better; and to determine how effective the combination of sorafenib and chemotherapy will be at killing cancer cells.

Who can participate?

For patients with High Allelic Ration FLT3/ITD.

What is involved?

Length of study 6 to 8 months. Tests and procedures include: Complete physical exams; Frequent labs to monitor blood counts and blood chemistries; Urine tests; X-rays and scans; Tests to monitor heart and lung functioning; Bone Marrow Aspirations and/or biopsies; Spinal Taps.

Contact Nemours Clinical Trials

Trial Name: A Phase III Randomized Trial for Patients With de Novo AML Using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND# 69896, NSC# 724772)

COG#: AAML1031

Contact Information

(800) 354-5690
clinicaltrials@nemours.org