Clinical Trial Goal
To find out if the combination of venetoclax and azacitidine or decitabine is safe and works well to treat AML that has not yet been treated or secondary AML
You may be able to join this trial if you:
- Are 18 years old or older
- Have acute myeloid leukemia (AML)
- Have either:
- Not yet had treatment for the leukemia and are not able to be treated with standard intensive chemotherapy (chemo) (your doctor can tell you this) or
- Have secondary AML and have been treated with azacitidine or decitabine for another disease (for example, myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN)) and the leukemia did not get better
- Do not have acute promyelocytic leukemia
- Have not been treated with venetoclax
- 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 and decitabine are drugs that block the growth of cancer cells. They are considered hypomethylating agents (HMA).
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
In this trial, you’ll be placed in 1 of 2 groups:
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
In this trial, you’ll be placed in 1 of 2 groups:
- Group 1 – Venetoclax plus azacitidine
- Group 2 – Venetoclax plus decitabine
The group you'll be placed in depends on whether or not you've been treated already with azacitidine or decitabine. If you've already been treated with azacitidine, you'll be in Group 2. If you've already been treated with decitabine, you'll be in Group 1. If you've never been treated with either azacitidine or decitabine, the clinical trial doctors will decide which group you're in.
You’ll get:
You’ll get:
- Venetoclax – A pill that you take by mouth 1 time each day
- Azacitidine – Group 1 only – Given as intravenous (IV) infusions or as shots under your skin 1 time each day for the first week of each month
- Decitabine – Group 2 only – Given as IV infusions 1 time each day for the first 5 days of each month
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 1 year.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them together in this way to treat AML that has not yet been treated or secondary AML is new and unproven.
Locations
UCLA / Jonsson Comprehensive Cancer CenterNOT_YET_RECRUITING
Los Angeles, California
Caspian Oliai, 310-206-6909, COliai@mednet.ucla.edu
UCSF-FresnoRECRUITING
Clovis, California
Mohammed Bukari, MD, 559-387-1900, mohammed.bukari@ucsf.edu
University of California Davis Comprehensive Cancer CenterRECRUITING
Sacramento, California
Brian A. Jonas, 916-734-3771, bajonas@ucdavis.edu
University of Oklahoma Health Sciences CenterNOT_YET_RECRUITING
Oklahoma City, Oklahoma
Matthew J. Wieduwilt, 405-217-8001, Matthew-Wieduwilt@ouhsc.edu
Sponsors
collaborator: AbbVie, collaborator: National Cancer Institute (NCI), lead: Brian Jonas
