Clinical Trial Goal
To find out:
- The highest dose of SNDX-5613 that’s safe to give
- If SNDX-5613 is safe and works well to treat acute leukemia with a KMT2A translocation or an NPM1 mutation that has relapsed or is refractory
You may be able to join this trial if you:
- Are 1 month old or older
- Have one of the following diseases that has relapsed or is refractory and there are no more standard treatments available:
- Acute myeloid leukemia (AML) with a KMT2A translocation (previously called MLL rearrangement)
- AML with an NPM1c mutation
- Acute lymphocytic leukemia (ALL) with a KMT2A translocation
- Acute biphenotypic leukemia with a KMT2A translocation
- Acute leukemia with a NUP98 rearrangement
- Do not have acute promyelocytic leukemia (APL)
- Have not had total body irradiation (TBI) in the last 2 months
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 2 months
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Cobicistat is a small molecule inhibitor that blocks CYP3A in certain cells.
SNDX-5613 is a small molecule inhibitor that blocks MLL1 and Menin in certain cells.
You’ll get:
SNDX-5613 is a small molecule inhibitor that blocks MLL1 and Menin in certain cells.
You’ll get:
- SNDX-5613 – A pill that you take by mouth. The dose you’ll get depends on when you start the trial and how safe it has been
- Cobicistat – A pill that you take by mouth 1 time each day. The clinical trial doctors will decide who gets this based on what's best for your health and when you joined the trial
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 treatment is working. The clinical trial doctors will check your health for about 5 years.
The Food and Drug Administration (FDA) not yet approved SNDX-5613. The FDA has approved cobicistat to treat human immunodeficiency virus (HIV) infection.
Locations
Sponsors
lead: Syndax Pharmaceuticals
