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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.
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
Children’s Oncology Group (AAML1031)
National Cancer Institute
Study Description at National Institutes of Health
Jean Tersak, MD
For more information about the study or enrollment, please contact:
Clinical Research Nurse Coordinator Lisa Washington, RN, BSN
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
Children’s Hospital of Pittsburgh of UPMC
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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