RecruitingPHASE3INTERVENTIONAL

A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)

This study, called POLARIS-1, is a large international trial comparing a new medicine called olverembatinib with current standard treatments for a type of blood cancer. This cancer is called Philadelphia chromosome-positive Acute Lymphoblastic Leukaemia (Ph+ ALL). Doctors want to see if olverembatinib, given with chemotherapy, is safer and works better than current treatments, which are also given with chemotherapy. People who have recently been diagnosed with Ph+ ALL and are at least 18 years old may be able to take part. This trial is in its third phase, meaning it has already shown some promise in earlier stages and is now being tested on a larger group of people.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Ascentage Pharma Group Inc.

Enrolment target

350

Start

31 Aug 2023

Estimated completion

30 Jun 2029

Ph+ ALL Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

What is this study about?

This research study is for people who have just found out they have a specific type of blood cancer called Philadelphia chromosome-positive Acute Lymphoblastic Leukaemia, often shortened to Ph+ ALL. ALL starts in the white blood cells in your bone marrow. The 'Philadelphia chromosome' is a specific change found in the cells of some people with ALL, and 'positive' means you have this change.

The study aims to see if a new drug, olverembatinib, can be a better treatment when combined with chemotherapy, compared to the usual treatments (which are also a type of drug called a TKI, combined with chemotherapy). Doctors will carefully check how well these treatments work to reduce the cancer and if they cause any unwanted side effects. The information gathered will help doctors decide if olverembatinib should become a standard treatment for Ph+ ALL in the future.

This is a 'Phase 3' study, which means it's one of the final steps before a new treatment might become widely available. It's also 'randomised', which means that participants will be put into different treatment groups by chance, like flipping a coin. This helps make sure the study results are fair and reliable.

Key takeaways

Studying a new drug (olverembatinib) for newly diagnosed Ph+ ALL.
Compares the new drug with current standard treatments.
Involves chemotherapy alongside the study drugs.
This is a Phase 3 trial, meaning it's a large, important study.
Participation includes regular check-ups and medical tests.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or over and have recently been diagnosed with Philadelphia chromosome-positive Acute Lymphoblastic Leukaemia (Ph+ ALL). You should also be generally well enough to take part and expect to live for at least three more months. Your body's organs, like your kidneys and liver, need to be working properly, and your doctor will check this. You can't have any serious signs of cancer affecting your brain or spine, or certain other severe long-term medical conditions.

There are also some reasons why you might not be able to join. For example, if you have a history of a different type of blood cancer called chronic myeloid leukaemia (CML), or if you are taking blood-thinning medicines at high doses. You also can't participate if you have severe or uncontrolled heart problems, active infections, or certain autoimmune diseases. If you are pregnant or breastfeeding, or planning to become pregnant, you won't be able to join.

It's important to discuss your full medical history with the study doctors. They will review all your health information to make sure joining the study is safe and appropriate for you.

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.

Have I recently been diagnosed with Philadelphia chromosome-positive Acute Lymphoblastic Leukaemia (Ph+ ALL)?
Am I 18 years old or older?
Am I generally well enough, with my organs working correctly?
Do I have any severe heart problems or active infections?
Am I pregnant or breastfeeding, or planning to become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups. One group will receive the new drug, olverembatinib, along with chemotherapy. The other group will receive an approved standard TKI drug along with chemotherapy. You won't be able to choose which treatment you get, and neither will your doctor, which helps to keep the study fair.

You will have regular hospital visits for examinations, blood tests, and scans to check your health and how the treatment is working. You will receive your medication as directed by the study team. The total length of your participation will depend on how you respond to the treatment and the study plan, which the doctors will explain in detail. There will likely be a follow-up period even after your main treatment finishes.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to a new treatment that might be more effective than current options for Ph+ ALL. However, there's no guarantee the new drug will work for you, and it could also have side effects, some of which may be serious. The study team will carefully monitor your health throughout and inform you of any known risks. You can choose to leave the study at any time and for any reason, without it affecting your usual care.

Locations (90)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ascentage Investigative Site #1044
Verified postcode
Birmingham, United States· Not yet recruiting
Ascentage Investigative Site #1062
Verified postcode
Duarte, United States· Not yet recruiting
Ascentage Investigative Site #1134
Verified postcode
Los Angeles, United States· Not yet recruiting
Ascentage Investigative Site #1059
Verified postcode
Los Angeles, United States· Not yet recruiting
Ascentage Investigative Site #1142
Verified postcode
Miami, United States· Not yet recruiting
Ascentage Investigative Site #1045
Verified postcode
Augusta, United States· Not yet recruiting
Ascentage Investigative Site #1158
Verified postcode
Indianapolis, United States· Not yet recruiting
Ascentage Investigative Site #1069
Verified postcode
Indianapolis, United States· Not yet recruiting
Ascentage Investigative Site #1084
Verified postcode
Lexington, United States· Not yet recruiting
Ascentage Investigative Site #1064
Verified postcode
Hackensack, United States· Not yet recruiting
Ascentage Investigative Site #1098
Verified postcode
New Brunswick, United States· Not yet recruiting
Ascentage Investigative Site #1160
Verified postcode
Stony Brook, United States· Not yet recruiting

Common questions

What is Ph+ ALL?

Ph+ ALL is a type of fast-growing blood cancer that affects certain white blood cells. 'Ph+' means your cancer cells have a particular genetic change called the Philadelphia chromosome.

What is a 'TKI'?

TKI stands for 'tyrosine kinase inhibitor.' These are targeted medicines that block specific signals in cancer cells, helping to stop their growth.

How long will the study last if I join?

The exact duration of the study for you will depend on your individual response to treatment and the study design, but it will involve ongoing treatment and follow-up over a period of time.

Can I choose which treatment I get?

No, you will be assigned to a treatment group by chance (randomly). This is done to ensure the study results are fair and unbiased.

What is chemotherapy?

Chemotherapy is a type of cancer treatment that uses drugs to kill fast-growing cells, including cancer cells, throughout the body.

How to find out more

Ascentage Clinical Operations

clinical-trials@ascentage.com 301-291-5658 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.