Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I Trial of Sorafenib Maintenance Therapy for Patients With FLT3-ITD AML After Allogeneic Stem Cell Transplantation
Sorfenib works by slowing the spread of cancer cells. It has been used in other studies for patients with AML with the FLT3-ITD mutation and information from these studies suggests that sorafenib may help to control leukemia. The purpose of this study is to find the highest dose of sorafenib for maintenance therapy that can be safely used in participants with AML who have undergone allogeneic stem cell transplant.
Subjects will taken sorafenib orally either once or twice daily. Subjects will come to the
Bone Marrow Transplant Clinic 3 times (on Day 8, 15, and 30) during the first month of
treatment. After the first month, they will be seen every month for 3 months and then at 9
at 6 and 9 months. Subjects will have a physical exam and be asked questions regarding
general health and specific questions about any problems they might be having and any
medications they are taking.
Subjects will have standard blood tests every month for 12 months to check liver and kidney
function and complete blood count.
Subjects will have research blood tests on Days 8, 15 and 30 during the first month of
treatment.
Subjects will have a bone marrow biopsy after 3 months and 12 months of treatment.
Subjects will receive treatment for up to 12 months and be followed for 1 year after
completing the study.
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