Active not recruitingPHASE3INTERVENTIONAL

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

This important research study is for people who have recently been diagnosed with a type of blood cancer called chronic lymphocytic leukemia (CLL) and haven't had treatment for it yet. The main goal is to compare new drug combinations – one with acalabrutinib and venetoclax, and another with acalabrutinib, venetoclax, and obinutuzumab – against the standard chemotherapy treatments currently used. Doctors want to find out if these newer drug combinations are more effective at treating CLL and if they are safe for patients. This trial will help us understand the best ways to treat CLL in the future, offering hope for better outcomes for patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Acerta Pharma BV

Enrolment target

984

Start

25 Feb 2019

Estimated completion

31 Jan 2027

Chronic Lymphocytic Leukemia

What is this study about?

This study is a clinical trial focusing on chronic lymphocytic leukemia (CLL), a type of cancer that affects particular white blood cells. It's for people who have recently been diagnosed and haven't started treatment for their CLL yet. The main aim is to test new types of treatment which are drug combinations like acalabrutinib and venetoclax, sometimes with an additional drug called obinutuzumab. These are being compared against the traditional chemotherapy treatments often used for CLL.

Doctors want to see if these newer drug combinations are better at controlling the cancer and if they cause fewer side effects than current chemotherapy. Finding more effective and gentler treatments is really important for improving the lives of people with CLL. The study also wants to make sure these new treatments are safe.

The findings from this study will help doctors decide the best way to treat CLL in people who are newly diagnosed, especially for those whose cancer doesn't have a specific genetic change (called del(17p) or TP53 mutation). It's a big step in trying to find better options for patients going forward, offering the potential for improved health and quality of life.

Key takeaways

This study compares new drug combinations to standard chemotherapy for newly diagnosed CLL.
It's for people whose CLL hasn't been treated before and doesn't have specific genetic changes.
You will be randomly assigned to one of three treatment groups.
Participation involves regular clinic visits for treatment and check-ups.
You might receive a new treatment that could be more effective than current options.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you must be at least 18 years old and have been newly diagnosed with chronic lymphocytic leukemia (CLL) that needs treatment. You also need to be generally well enough to take part, meaning you can carry out most of your daily activities without much trouble, as assessed by your doctor.

There are also some reasons why you might not be able to join. For example, if you've already had treatment for your CLL, or if your CLL has changed into a more aggressive type of cancer. You also can't have certain genetic changes like del(17p) or TP53 mutation in your CLL cells. Specific other health conditions, like serious heart problems, recent major surgery, or certain infections, would also prevent you from participating.

Males and females are welcome to apply. If you are able to have children, you must agree to use highly effective birth control throughout the study to prevent pregnancy. This ensures everyone's safety during the trial.

Quick self-check

Are you at least 18 years old?
Have you been diagnosed with CLL that needs treatment for the first time?
Are you generally well and active?
Have you not had any prior treatment specifically for your CLL?
Do you not have specific genetic changes (like del(17p) or TP53 mutation) in your CLL?
Do you not have other serious medical conditions like recent heart problems or certain infections?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will first go through a screening period of up to 35 days to check if you are suitable. If you qualify, you will then be randomly assigned to one of three treatment groups, like flipping a coin, so it's fair. This means you could receive two new drugs (acalabrutinib and venetoclax), or three new drugs (acalabrutinib, venetoclax, and obinutuzumab), or standard chemotherapy (FCR or BR). You won't get to choose which group you are in.

You will receive your assigned treatment for a period determined by your doctors, and this will involve regular visits for check-ups, blood tests, and to make sure the treatment is working and that you are not having too many side effects. These visits will continue for as long as you are on the study drugs. After you stop taking the study medication, there will be a follow-up phase where doctors will continue to monitor your health. The total time you are involved in the study will vary depending on your treatment and how long you need to be followed up, but it will involve multiple visits over an extended period.

Potential risks and benefits

Taking part in this study could offer you the chance to receive new treatments for your CLL that might be more effective or have different side effects compared to standard options. However, as with any medical treatment, there are potential risks, including new or unexpected side effects from the study drugs. Some side effects could be serious, and the new treatments might not work for everyone. You will be closely monitored by the study team, and they will explain all known side effects. Remember, joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (170)

Research Site
Los Angeles, United States
Research Site
Redondo Beach, United States
Research Site
Fort Wayne, United States
Research Site
Wichita, United States
Research Site
Louisville, United States
Research Site
New Orleans, United States
Research Site
Baltimore, United States
Research Site
Boston, United States
Research Site
New York, United States
Research Site
Charlotte, United States
Research Site
Canton, United States
Research Site
Pittsburgh, United States

+158 more sites — see the official record for the full list.

Common questions

What is CLL?

CLL stands for chronic lymphocytic leukemia. It's a slow-growing cancer that affects white blood cells in your blood and bone marrow.

What are new drug combinations?

These are treatments using several different medicines together. In this study, they include acalabrutinib and venetoclax, sometimes with obinutuzumab.

What is 'chemoimmunotherapy'?

This is a standard treatment for CLL that combines chemotherapy (strong cancer-fighting drugs) with immunotherapy (drugs that help your immune system fight cancer).

Why is this study important for me?

This study might offer you access to new treatments for your CLL that are not yet widely available. It also helps doctors learn the best ways to treat CLL in the future.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, which means both you and your doctor will know which specific treatment you are receiving once you are assigned to a group.