Clinical Trial Goal
To find out if olverembatinib is safe and works well to treat CML in chronic phase, compared to bosutinib
You may be able to join this trial if you:
- Are 18-99 years old
- Have CML in chronic phase
- Have one of the following:
- Been previously treated with at least 2 TKIs. Your doctor can tell you this
- Mutation T315L. Your doctor can tell you this
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Bosutinib and olverembatinib are tyrosine kinase inhibitors (TKIs) that block BCR-ABL in certain cells.
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:
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 – Bosutinib
- Group 2 – Olverembatinib
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:
- Bosutinib – Group 1 only - A pill that you take by mouth every other day
- Olverembatinib – Group 2 only - A pill that you take by mouth 1 time each day
You may continue treatment for 6 months. You'll have biopsies to see how well the treatment is working.
The Food and Drug Administration (FDA) has not yet approved olverembatinib, though it has been approved in other countries for the treatment of CML.
Contacts
Kate Shantz, 301-509-0038, kate.shantz@ascentage.com
Huanshan Guo, huanshan.guo@ascentage.com
Locations
MD Anderson Cancer CenterRECRUITING
Houston, Texas
Sponsors
lead: Ascentage Pharma Group Inc.
