Clinical Trial Goal
To find out:
- The highest dose of iadademstat that’s safe to give with gilteritinib
- If the combination of gilteritinib and iadademstat is safe and works well to treat FLT3+ AML that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have AML that has relapsed 1-2 times or is refractory
- Have disease/cancer cells with a FLT3 mutation. Your doctor can tell you this
- Do not have acute promyelocytic leukemia
- Do not have a BCR-ABL gene. Your doctor can tell you this
- Have not been treated with iadademstat. Your doctor can tell you this
- Have not been treated with more than 2 lines of therapy
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Gilteritinib is a small molecule inhibitor that blocks FLT3 in certain cells.
Iadademstat is a small molecule inhibitor that blocks LSD1 in certain cells.
You’ll get:
Iadademstat is a small molecule inhibitor that blocks LSD1 in certain cells.
You’ll get:
- Gilteritinib – A pill that you take by mouth
- Iadademstat - A liquid that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 2 years.
The Food and Drug Administration (FDA) has approved gilteritinib to treat AML. The FDA has not yet approved iadademstat.
Contacts
Mónica Reale-Vidal, MD, +34 935151313, FRIDA_queries@oryzon.com
Sonia Gutiérrez, MSc, +34 935151313, FRIDA_queries@oryzon.com
Locations
Sponsors
lead: Oryzon Genomics S.A.
