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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.

What is the Condition Being Studied?

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

Age Group
Adults

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.

Study Details

Full Title
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB:PRO00084711
NCT:NCT02997202
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698