Clinical Trial Goal
To find out if QTX-2101 is safe and works well to treat low or intermediate-risk APL
You may be able to join this trial if you:
- Are 18 - 71 years old
- Have APL that doctor's consider to be low or intermediate risk
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
All-trans-retinoic-acid (ATRA) is a form of vitamin A that forces APL cells to mature and die.
Arsenic trioxide (ATO) is a type of targeted chemotherapy (chemo) that blocks the growth of cancer cells.
QTX-2101 is ATO in pill form (oral).
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
Arsenic trioxide (ATO) is a type of targeted chemotherapy (chemo) that blocks the growth of cancer cells.
QTX-2101 is ATO in pill form (oral).
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 – ATRA plus QTX-2101
- Group 2 – ATO plus ATRA
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.
You’ll get treatment in cycles that last 2 months. In each cycle, you'll get:
- ATRA – A pill that you take by mouth 1 time each day for 1 month
- ATO – Group 2 only - Given as intravenous (IV) infusions 1 time each day
- QTX-2101 – Group 1 only - A pill that you take by mouth 1 time each day
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 approved IV ATO. Using it in pill form (QTX-2101) is new and unproven.
Locations
Quetzal Site 1RECRUITING
Duarte, California
Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com
Quetzal Site 2RECRUITING
The Bronx, New York
Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com
Quetzal Site 4RECRUITING
Buffalo, New York
Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com
Quetzal Site 3RECRUITING
Charlottesville, Virginia
Quetzal Therapeutics Investigator, +13126800501, ClinicalTrials@QuetzalTx.com
Sponsors
lead: Quetzal Therapeutics
