BMT CTN 1506_Gilteritinib Following Allogenic transplant for FLT3/ITD AML - Clinical Trial
What is the Purpose of this Study?
We are doing this study to learn if it is safe and effective (works well) to treat patients who have FLT3/ITD AML with a study drug called gilteritinib after transplant. We want to know if this drug works better than a placebo to stop the AML from coming back and what kind of side-effects it may cause.
AML patients with the FLT3/ITD genetic mutation who are eligible for allogeneic transplant
Who Can Participate in the Study?
Adult men and women who are
- Candidates for allogeneic transplant
- Have AML with the FLT3 AML genetic mutation in a CR1 following consolidation therapy
- Have not had a previous allogeneic transplant
What is Involved?
If you join the study, you will
- Go through a screening process that includes having a bone marrow biopsy (removal of soft tissue in the bone) that must be done at Duke, blood tests, physical exams, and other tests and questionnaires
- Be randomized (like the flip of a coin) to receive the drug gilteritinib or placebo (a sugar pill) for two years starting 30-90 days after your allogeneic transplant
--- Neither you nor your study team or doctor will know what you are taking (although they can find out in an emergency)
- Have bone marrow biopsies between 30-90 days, 3 months, 6 months, 12, months, 18 months, and 24 months after your transplant
- Complete health quality of life surveys 8 times during the study
- Have blood tests monthly while on study drug
- Have ECG during screening and monthly while on study drug
- Followed for survival for up to 5 years after stopping drug.