Clinical Trial Goal
To find out:
- The highest dose of revumenib that’s safe to give with standard therapy
- If the combination of revumenib and standard therapy is safe and works well to treat FLT3+ AML that has not yet been treated
You may be able to join this trial if you:
- Are 18 - 75 years old
- Have AML that has had little to no treatment
- Have cancer cells with one of the following mutations. Your doctor can tell you this
- FLT3-ITD
- TKD
- NPM1
- Do not have acute promyelocytic leukemia
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Cytarabine and daunorubicin are chemotherapy (chemo) drugs that block the growth of cancer cells.
Midostaurin is a small molecule inhibitor that blocks FLT3, KIT and PDGF in certain cells.
Revumenib is a menin inhibitor that blocks interaction between the menin protein and the KMT2A protein.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
Midostaurin is a small molecule inhibitor that blocks FLT3, KIT and PDGF in certain cells.
Revumenib is a menin inhibitor that blocks interaction between the menin protein and the KMT2A protein.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Cytarabine – Given as intravenous (IV) infusions 1 time each day for up to 1 week
- Daunorubicin - Given as IV infusions 1 time each day for up to 3 days
- Midostaurin - A pill that you take by mouth 2 times each day for 2 weeks
- Revumenib - A pill that you take by mouth 1-2 times daily. 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 1 year.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial to treat acute leukemia.
Locations
Brigham and Women's HospitalRECRUITING
Boston, Massachusetts
Richard Stone, MD, 617-632-5157, richard_stone@dfci.harvard.edu
Dana-Farber Cancer InstituteRECRUITING
Boston, Massachusetts
Richard Stone, MD, 617-632-5157, richard_stone@dfci.harvard.edu
Sponsors
collaborator: Syndax Pharmaceuticals, lead: Richard Stone, MD
