Study of Olverembatinib (HQP1351) in Patients With CML-CP
This research study is investigating a new medication called olverembatinib for patients with Chronic Myeloid Leukemia (CML) in its chronic phase (CML-CP). The study has two main parts. One part compares how well olverembatinib works and its safety against an approved medicine called bosutinib. The other part specifically looks at olverembatinib in patients who have a particular genetic change in their CML, known as the T315I mutation. The aim is to see if olverembatinib is a safe and effective new treatment option for people living with CML-CP, especially for those who might not have other good treatment choices.
At a glance
What is this study about?
This research study is about finding new and better ways to treat a type of blood cancer called Chronic Myeloid Leukemia (CML). Specifically, it focuses on CML in its early, chronic phase (CML-CP). For people with CML-CP, treatments often involve medicines that target the cancer cells. However, sometimes these treatments stop working, or patients develop specific changes in their cancer cells that make current medicines less effective.
The study has two main goals. The first part compares a new, experimental medicine called olverembatinib with a medicine that's already approved and used, called bosutinib. This is to see which medicine works better and is safer for people with CML-CP who have already tried at least two other similar treatments. The second part of the study looks at olverembatinib on its own, for people with CML-CP who have a specific genetic change (called a T315I mutation) in their cancer cells. This mutation can make some CML medicines less effective, so finding new options is very important.
The overall aim of this study is to gather information that will help doctors understand if olverembatinib could be a useful new treatment option for people with CML-CP, especially for those who need more choices. If the study shows that olverembatinib is safe and effective, it could become available to more patients in the future.
Key takeaways
- The study explores a new CML medicine called olverembatinib.
- It aims to find better treatments for CML, especially when other medicines haven't worked or for specific genetic changes.
- Participation involves taking medication and attending regular check-ups.
- There are potential benefits and risks, which your doctor will explain fully.
- You can stop participating in the study at any time without affecting your normal care.
Who may be eligible?
To join this study, you need to be at least 18 years old and have a diagnosis of Chronic Myeloid Leukemia in its chronic phase (CML-CP). For the first part of the study (comparing olverembatinib with bosutinib), you must have already tried at least two other similar CML medicines. For the second part (for people with a specific genetic change), you need to have the T315I mutation and have tried at least one other CML medicine, without other good treatment options available.
Your general health also needs to be good enough to take part. This means your body's organs should be working properly, and you should be able to carry out most of your usual daily activities without too much difficulty. A doctor will check these things to make sure the study is safe for you.
However, there are some reasons why you might not be able to join. For example, if you have a certain genetic change (T315I or V299L) *before* starting treatment in the comparison part of the study. You also can't join if you have an active infection, problems with your gut that might affect how the medicine works, or if you've had a bad reaction to the study drugs before. Pregnant or breastfeeding women cannot participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with CML-CP (Chronic Myeloid Leukemia - Chronic Phase)?
- Have you already tried at least two other CML medicines (or one if you have the T315I gene change)?
- Are you generally well enough to do most daily activities?
- Are you NOT pregnant or breastfeeding?
What does participation involve?
If you decide to take part in this study, you will be given either the new medicine (olverembatinib) or an existing one (bosutinib) as tablets. The study will involve regular visits to the hospital or clinic where doctors and nurses will monitor your health, check how you are responding to the treatment, and look for any side effects. These checks will include blood tests, physical examinations, and possibly other tests.
For the first part of the study, you won't know whether you're getting olverembatinib or bosutinib, but both are active treatments. For the second part, everyone receives olverembatinib. If you are in the comparison part and your current treatment stops working, you might have the option to switch to olverembatinib later on. The total duration of your participation, including treatment and follow-up, will be explained in detail by the study team, as it can vary.
Potential risks and benefits
Locations (163)
- Ascentage Investigative Site #1044Verified postcodeBirmingham, United States· Recruiting
- Ascentage Investigative Site #1112Verified postcodeAnchorage, United States· Recruiting
- Ascentage Investigative Site #1111Verified postcodeGoodyear, United States· Recruiting
- Ascentage Investigative Site #1062Verified postcodeDuarte, United States· Recruiting
- Ascentage Investigative Site #1099Verified postcodeIrvine, United States· Recruiting
- Ascentage Investigative Site #1075Verified postcodeLa Jolla, United States· Recruiting
- Ascentage Investigative Site #1100Verified postcodeLong Beach, United States· Recruiting
- Ascentage Investigative Site #1059Verified postcodeLos Angeles, United States· Recruiting
- Ascentage Investigative Site #1121Verified postcodeSacramento, United States· Recruiting
- Ascentage Investigative Site #1109Verified postcodeUpland, United States· Recruiting
- Ascentage Investigative Site #1045Verified postcodeAugusta, United States· Recruiting
- Ascentage Investigative Site #1110Verified postcodeNewnan, United States· Recruiting
Common questions
What is CML-CP?
CML-CP stands for Chronic Myeloid Leukemia - Chronic Phase. It's a type of blood cancer that starts in the bone marrow, and the chronic phase is usually the earlier, slower-progressing stage of the disease.
What is olverembatinib?
Olverembatinib is a new medicine being tested in this study. It's designed to treat CML by targeting specific pathways that help cancer cells grow. It's not yet approved for general use.
What is the T315I mutation?
The T315I mutation is a specific change in the genetic make-up of CML cancer cells. This change can sometimes make certain CML medicines less effective, so new treatments are needed for people with this mutation.
Will I know which medicine I'm getting?
If you are in the part of the study comparing olverembatinib and bosutinib, you will not know which medicine you are receiving. If you are in the part looking at the T315I mutation, you will receive olverembatinib.
Can I leave the study at any time?
Yes, you have the right to withdraw from the study at any point, for any reason, without it affecting your medical care.
How to find out more
Ascentage Clinical Operations
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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