Clinical Trial Goal
To find out if DFP-10917 is safe and works well to treat AML that has relapsed or is refractory compared to standard chemo
You may be able to join this trial if you:
- Are 18 years old or older
- Have AML that has relapsed or is refractory
- Have had at least 2, but no more than 4, different treatments for the leukemia
- Do not have acute promyelocytic leukemia
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 3 months
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Azacitidine, cladribine, cytarabine, decitabine, DFP-10917, etoposide, fludarabine are drugs that block the growth of cancer cells.
Granulocyte colony-stimulating factor (G-CSF) helps normal white blood cells recover from treatment.
Idarubicin is a small molecule inhibitor that blocks topoisomerase II in certain cells.
Mitoxantrone is a drug that blocks topoisomerase II in certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told which group you’re in:
Granulocyte colony-stimulating factor (G-CSF) helps normal white blood cells recover from treatment.
Idarubicin is a small molecule inhibitor that blocks topoisomerase II in certain cells.
Mitoxantrone is a drug that blocks topoisomerase II in certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told which group you’re in:
- Group 1 – DFP-10917
- Group 2 – Standard chemo
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
If you’re in Group 1, you’ll get DFP-10917, given as a continuous intravenous (IV) infusions for 2 weeks. Then you’ll have 2 weeks with no treatment and repeat. The drug is given by a small pump that you’ll carry with you the whole time. You’ll get a shoulder bag or belt bag that holds the pump and the drug. You'll be able to wear regular clothes, walk around, and perform normal daily activities.
If you’re in Group 2, you’ll get a combination of the following depending on what treatment you’ve already had:
- Azacitidine – Given as a shot under your skin or IV infusion 1 time each day for 1 week of each month
- Cladribine – Given as IV infusions 5 times each month
- Cytarabine – Given as a shot under your skin 1-2 times each day for 5-10 days of each month or as IV infusions for the first 5-6 days of each month. Each infusion takes up to 6 hours
- Decitabine – Given as continuous IV infusions for 5 days of each month
- Etoposide – Given as IV infusions 1 time each day for the first 6 days of each month. Each infusion takes 1 hour
- Fludarabine – Given as IV infusions for the first 5 days of each month. Each infusion takes 30 minutes
- G-CSF – Given as a shot under the skin until your white blood cell count recovers
- Idarubicin – Given as IV infusions 1 time each day for the first 3 days of each month
- Mitoxantrone – Given as IV infusions 1 time each day for the first 3-6 days of each month
- Venetoclax – A pill that you take by mouth 1 time each day
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 3 years.
The Food and Drug Administration (FDA) has not yet approved DFP-10917. The FDA has approved all of the other drugs used in this trial.
Locations
Sponsors
lead: Delta-Fly Pharma, Inc.
