Phase I Trial of Sorafenib Maintenance Therapy for Patients With FLT3-ITD AML After Allogeneic Stem Cell Transplantation
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
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
To define the maximum tolerated dose (MTD) of maintenance sorafenib after allogeneic HSCT
Yi-Bin Chen, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|