Acute Myeloid Leukemia trial using Bortezomib and Sorafenib – Phase III

Trial for Patients with de novo Acute Myeloid Leukemia using Bortezomib and Sorafenib for Patients with High Allelic Ratio FLT3/ITD

Protocol Description

This multicenter trial by the Children’s Oncology Group investigates how well bortezomib and sorafenib tosylate work in treating patients with acute myeloid leukemia (AML) diagnosed as high-risk due to a change in the FLT3/ITD+ gene. Approximately 20 percent of patients with this condition can be cured with standard chemotherapy. Investigators believe that using bortezomib and sorafenib tosylate in combination with standard chemotherapy may stop cancer cell proliferation by blocking certain enzymes needed for cell growth, thereby improving the cure rate.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to males and females, up to age 29, who have been newly diagnosed with de novo acute myelogenous leukemia (AML).
Males and Females: Up to age 29


Study participants may be assigned to one of three groups. Treatment arm A is standard chemotherapy administered by intravenous infusion; treatment arm B is standard chemotherapy plus bortezomib; treatment arm C is standard chemotherapy plus oral doses of sorafenib. As part of standard care, participants may require radiation therapy and may also receive a bone marrow transplant from a matched donor.
Visits: The same number of visits as required for standard therapy
Duration: 20-23 weeks

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (AAML1031)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Clinical Research Nurse Coordinator Lisa Washington, RN, BSN