Clinical Trial Goal
To find out:
- The highest dose of tagraxofusp that's safe to give with standard chemo
- If the combination of tagraxofusp and standard chemo is safe and works well to treat AML that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years or older
- Have AML that has relapsed or is refractory
- Have cancer cells with mutation/marker CD123 (CD123+). Your doctor can tell you this
- Have not been treated with a combination of venetoclax and a hypomethylating agent (HMA). Your doctor can tell you this
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT)
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Cladribine is a chemotherapy (chemo) drug that blocks the growth of cancer cells.
Cytarabine is a chemotherapy (chemo) drug that blocks the growth of cancer cells.
Tagraxofusp is an antibody-drug conjugate that targets CD123 on certain cells.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
Cytarabine is a chemotherapy (chemo) drug that blocks the growth of cancer cells.
Tagraxofusp is an antibody-drug conjugate that targets CD123 on certain cells.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Cladribine – Given as intravenous (IV) infusions 1 time each day for up to 5 days
- Cytarabine – Given as IV infusions 1 time each day for up to 10 days
- Tagraxofusp – Given as IV infusions for 3 days
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 all of the drugs used in this trial. Using them in this way to treat AML that has relapsed or is refractory is new and unproven.
Locations
Stanford UniversityRECRUITING
Palo Alto, California
Woo In (Yustina) Cho, 650-721-2443, wooin@stanford.edu
Sponsors
collaborator: Stemline Therapeutics, Inc., lead: Stanford University
