Clinical Trial Goal
To find out:
- The highest dose of eltanexor that's safe to give with venetoclax
- If the combination of eltanexor and venetoclax is safe and works well to treat AML and MDS that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have AML or MDS that has relapsed or is refractory
- Have not been treated with any of the following (your doctor can tell you this):
- SINE compound
- XPO1 inhibitor
- Have not had allogeneic (cells from a donor) or autologous (your own cells) blood or marrow transplant in the last 3 months
- Have not had any kind of cellular therapy like CAR T-cell therapy, in the last 3 months
- Do not have graft-versus-host-disease (GVHD)
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Eltanexor (KPT-8602), is a small molecule inhibitor that blocks XPO1 on certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Eltanexor – A pill that you take by mouth up to 1 time each day
- Venetoclax – A pill that you take by mouth 1 time each day for 2 weeks
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 not yet approved eltanexor.
Locations
Vanderbilt University/Ingram Cancer CenterRECRUITING
Nashville, Tennessee
Vanderbilt-Ingram Service Services for Timely Access, 800-811-8480, cip@vumc.org
Sponsors
collaborator: Karyopharm Therapeutics Inc, collaborator: National Cancer Institute (NCI), lead: Vanderbilt-Ingram Cancer Center
