AAML1031: A Phase III Randomized Trial for Patients with de novo AML using Bortezomib and Sorafenib (BAY 43-9006) for Patients with High Allelic Ratio FLT3/ITD.
A study of adding study drug Sorafenib to the usual treatment in children and teens with AML (Acute Myeloid Leukemia)
Sponsor: National Cancer Institute NCI
Enrolling: Male and Female Patients
IRB Number: AAAI4455
U.S. Govt. ID: NCT01371981
Contact: Alice Lee: 212-305-5808 / al2041@cumc.columbia.edu
Additional Study Information: This study is for children and teens who have been diagnosed with Acute Myeloid Leukemia (AML). 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 overall goal of this study is to see if we can increase this cure rate withoutcausing more serious side effects of therapy. Side effects are unintended and unwanted resultsof treatment. Another goal of the study is to understand the biology of AML better. Study doctors want to test blood or bone marrow for certain genetic changes (called genetic markers) in leukemia cells attime of diagnosis. This would help them to learn more about AML and how to treat patients better. They also want to look for very small amounts of leukemia. This is called minimal residual disease (MRD). Researchers will be using MRD and some particular genetic markers to predict a subjects risk of the leukemia coming back (relapse).
This study is closed
Alice Lee, MD
Do You Qualify?
Has your child been diagnosed with AML? Yes No
You may be eligible for this study

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For more information, please contact:
Alice Lee