Clinical Trial Goal
To find out if the combination of cedazuridine and decitabine, alone or with the drugs enasidenib, glilteritinib, ivosidenib or venetoclax, is safe and works well to treat AML that’s in remission
You may be able to join this trial if you:
- Are 18 years old or older
- The AML is in remission for the first time
- 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
Cedazuridine is a drug that blocks CDA in certain cells.
Decitabine is a drug that blocks the growth of cancer cells.
Enasidenib is a small molecule inhibitor that blocks IDH2 in certain cells.
Gilteritinib is a small molecule inhibitor that blocks FLT3 in certain cells.
Ivosidenib is a small molecule inhibitor that blocks IDH1 in certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
In this trial, you'll be placed in 1 of 5 groups:
Decitabine is a drug that blocks the growth of cancer cells.
Enasidenib is a small molecule inhibitor that blocks IDH2 in certain cells.
Gilteritinib is a small molecule inhibitor that blocks FLT3 in certain cells.
Ivosidenib is a small molecule inhibitor that blocks IDH1 in certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
In this trial, you'll be placed in 1 of 5 groups:
- Group 1 - Cedazuridine and decitabine
- Group 2 - Cedazuridine, decitabine and enasidenib
- Group 3 - Cedazuridine, decitabine and gilteritinib
- Group 4 - Cedazuridine, decitabine and ivosidenib
- Group 5 - Cedazuridine, decitabine and venetoclax
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Cedazuridine –A pill that you take by mouth 1 time each day for the first 3 days of each cycle
- Decitabine – A pill that you take by mouth 1 time each day for the first 3 days of each cycle
- Enasidenib – Group 2 only - A pill that you take by mouth 1 time each day
- Gilteritinib – Group 3x only - A pill that you take by mouth 1 time each day
- Ivosidenib – Group 4 only - A pill that you take by mouth 1 time each day
- Venetoclax – Group 5 only - A pill that you take by mouth 1 time each day for the first 5 days of each cycle
You may continue treatment for up to 2 years. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 5 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 in remission is new and unproven.
Locations
M D Anderson Cancer CenterRECRUITING
Houston, Texas
Tapan M. Kadia, 713-792-7305, tkadia@mdanderson.org
Sponsors
collaborator: National Cancer Institute (NCI), lead: M.D. Anderson Cancer Center
