Active not recruitingPHASE3INTERVENTIONAL

A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This research study is looking at two different combinations of medicines for people who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and haven't had treatment before. One combination uses Acalabrutinib and Venetoclax, while the other uses Venetoclax and Obinutuzumab. The main goal is to find out if one of these treatment approaches is more effective and has fewer side effects than the other. Participants will be randomly assigned to one of the two treatment groups. The study will monitor their health and the effects of the treatment over about five years to gather important information that could help future patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

607

Start

12 Sep 2022

Estimated completion

10 Apr 2029

Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

What is this study about?

This study is a clinical trial designed to compare two different treatment plans for people diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not yet received any treatment for their condition. CLL and SLL are types of cancer that affect white blood cells in your body.

The study will look at two combinations of medicines: one group of people will receive a combination of Acalabrutinib and Venetoclax, and another group will receive Venetoclax and Obinutuzumab. Both combinations are already known treatments in some settings, but doctors want to understand if one combination works better or is safer than the other for people who are starting treatment for the first time.

This kind of study is important because it helps doctors learn which treatments are most effective and have the best results for patients. By carefully comparing these two treatment approaches, researchers hope to improve care for people with CLL or SLL in the future. The study is set up so that participants are randomly assigned to one of the two groups, which helps ensure the comparison is fair and accurate.

Key takeaways

Compares two drug combinations for previously untreated CLL/SLL.
Acalabrutinib/Venetoclax vs. Venetoclax/Obinutuzumab are being tested.
Participation lasts approximately 5 years.
You will be randomly assigned to one treatment group.
Regular health checks throughout the study.
You can withdraw from the study at any time.

Who may be eligible?

To be able to join this study, you must be at least 18 years old and have been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) for which your doctor believes treatment is needed. You must not have received any previous treatment for your CLL or SLL.

Your body's systems, like your bone marrow, kidneys, and liver, need to be working well enough to participate safely. This means your blood test results for things like white blood cells, platelets, and kidney and liver function must fall within certain ranges. A doctor will check these to make sure it's safe for you to take part.

You should also be generally well enough to go about your daily activities with little to no difficulty, and you must be able to understand what the study involves and agree to take part by signing a consent form. You also need to be able to swallow capsules and tablets without problems.

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 at least 18 years old?
Do you have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)?
Have you *not* had any treatment for your CLL or SLL before?
Are your kidney and liver tests generally within healthy ranges?
Are you able to swallow capsules and tablets without difficulty?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening period where doctors will perform tests to make sure the study is suitable for you. If you qualify, you will then be randomly assigned to one of two treatment groups – like flipping a coin, you'll get either the Acalabrutinib plus Venetoclax combination or the Venetoclax plus Obinutuzumab combination. You won't get to choose which group you are in.

You will receive your assigned treatment, and you'll have regular hospital visits for check-ups. During these visits, doctors and nurses will carry out various tests and assessments to monitor your health, how effectively the treatment is working, and to check for any side effects. These could include blood tests, physical exams, and other medical evaluations.

The study involves participation for approximately 5 years. Even if you stop taking the study medication early, for any reason, the study team will still want to keep in touch to check on your health and survival status, unless you specifically withdraw your permission for them to do so.

Potential risks and benefits

Participating in this study might offer you access to new treatment approaches for your CLL or SLL under close medical supervision. While there's no guarantee the treatment will work for you, your involvement will provide valuable information that could help future patients. Every medication has potential side effects, and you might experience unwanted reactions to the study drugs. Doctors will closely monitor you for any side effects, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (37)

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Tucson, United States
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La Jolla, United States
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Longmont, United States
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Jacksonville, United States
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Boston, United States
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Rochester, United States
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St Louis, United States
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Buffalo, United States
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New Hyde Park, United States
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New York, United States
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Rochester, United States
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Charlotte, United States

Common questions

What is chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)?

These are types of slow-growing cancers that affect white blood cells called lymphocytes.

Why are doctors doing this study?

They want to find out if one of two new treatment combinations works better and is safer for people who haven't been treated for CLL/SLL before.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to one of the two treatment groups, like drawing lots or flipping a coin.

How long will I be involved in the study?

Your involvement in the study will last for about 5 years.

Can I leave the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.