Clinical Trial Goal
To find out:
- The highest dose of BTX-A51 that’s safe to give
- If BTX-A51, with or without azacitidine, is safe and works well to treat AML or MDS that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have 1 of the following diseases that has relapsed or is refractory:
- AML
- MDS that doctors consider high risk and there are no more standard treatments available
- Do not have acute promyelocytic leukemia
- Have not had a 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 is a drug that blocks the growth of cancer cells.
BTX-A51 is a small molecule inhibitor that blocks CK1-alpha and CDK7/CDK9 in certain cells.
In this trial, you’ll be in 1 of 2 groups:
BTX-A51 is a small molecule inhibitor that blocks CK1-alpha and CDK7/CDK9 in certain cells.
In this trial, you’ll be in 1 of 2 groups:
- Group 1 – BTX-A51
- Group 2 – BTX-A51 plus azacitidine
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Azacitidine - Group 2 only - Given as intravenous (IV) infusions or as a shot under your skin 1 time each day for 1 week
- BTX-A51 – A pill that you take by mouth. The dose and number of doses you'll get depends on when you start the trial and how safe it has been.
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 about 2 years.
The Food and Drug Administration (FDA) has approved azacitidine and has not yet approved BTX-A51.
Locations
City of Hope National Medical CenterRECRUITING
Duarte, California
Brian Ball, MD, 626-218-4784, brball@coh.org
Memorial Sloan-Kettering Cancer CenterRECRUITING
New York, New York
Eytan Stein, MD, 646-608-3749, SteinE@mskcc.org
The University of Texas MD Anderson Cancer CenterRECRUITING
Houston, Texas
Gautam Borthakur, MD, 713-563-1586, Gborthak@mdanderson.org
Sponsors
lead: Edgewood Oncology Inc.
