RecruitingPHASE3INTERVENTIONAL

A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL

This study looks at new ways to treat chronic lymphocytic leukaemia (CLL), a type of blood cancer. Specifically, it focuses on patients with 'high-risk' CLL, meaning their cancer is harder to treat. Doctors want to find out if adding an extra drug, Acalabrutinib, to a standard two-drug treatment (Obinutuzumab and Venetoclax) can help patients live longer without their disease getting worse. The study will openly compare these two treatments to see which one works better. It's an important step in finding more effective treatments for people with this challenging form of CLL.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

German CLL Study Group

Enrolment target

202

Start

19 Apr 2022

Estimated completion

01 May 2028

Chronic Lymphocytic Leukemia

What is this study about?

This study is about a type of blood cancer called chronic lymphocytic leukaemia, or CLL. For some people, CLL is considered 'high-risk,' meaning it's more aggressive and harder to treat. Doctors already have ways to treat CLL, but they are always looking for better solutions, especially for these high-risk cases. Currently, there isn't a cure for high-risk CLL, so finding effective treatments is very important.

In this study, researchers are comparing two different drug combinations. Both combinations are 'chemo-free,' meaning they don't use traditional chemotherapy, and they are given for a set period. One treatment uses two drugs: Obinutuzumab and Venetoclax. The other treatment adds a third drug, Acalabrutinib, to these two. The main goal is to see if the three-drug combination can keep the CLL from getting worse for a longer time compared to the two-drug combination. This is known as 'progression-free survival'.

Identifying high-risk CLL is done through special tests that look at the cancer's genetic features. These features can include things like a '17p-deletion,' 'TP53-mutation,' 'complex karyotype,' or 'unmutated IGHV gene status.' If you have one or more of these, you might be considered high-risk. This study aims to directly compare new drug treatments for patients with these specific high-risk features, hoping to improve their outcomes.

Key takeaways

This study compares two different drug treatments for high-risk CLL.
It aims to find out if three drugs are better than two at preventing the disease from getting worse.
The treatments are chemo-free and given for a set period.
Participation involves regular medical appointments and monitoring.
You will be randomly assigned to one of the treatment groups.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must have been diagnosed with chronic lymphocytic leukaemia (CLL) or a similar condition, SLL, and your doctors believe you need treatment. You also need to be at least 18 years old.

A key requirement is that your CLL must be considered 'high-risk,' which doctors identify through specific genetic tests on your cancer cells. These include certain changes like a 17p-deletion, TP53-mutation, complex karyotype, or an unmutated IGHV gene. You also need to be generally stable enough to participate, with certain blood counts, kidney, and liver functions within a healthy range, and no severe heart conditions or other life-threatening illnesses.

You cannot join if you have already received any treatment for your CLL (apart from short-term steroid use). Also, if you have certain infections like active Hepatitis B or C, or if your CLL has transformed into a more aggressive type of lymphoma, you wouldn't be able to take part.

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.

Do I have a diagnosis of CLL or SLL that needs treatment?
Am I at least 18 years old?
Have tests shown that my CLL is 'high-risk' (e.g., 17p-deletion, TP53-mutation, complex karyotype, or unmutated IGHV)?
Have I NOT had any previous treatment for my CLL (besides short-term steroids)?
Am I generally healthy enough, with good organ function (kidneys, liver, blood counts)?
Do I currently have an active serious infection like Hepatitis B or C, or has my CLL turned into another type of lymphoma?

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 receive one of two treatment combinations. This means you won't choose which treatment you get, it's decided by chance, like flipping a coin, to ensure a fair comparison.

You will receive your medications and have regular check-ups with the study team. These check-ups will involve blood tests to monitor your health and how the treatment is affecting your CLL, as well as tests to check for any side effects. You will also have physical examinations. The exact number of visits and tests will be explained in detail by the study team.

The treatments are for a fixed period of time, meaning they don't continue indefinitely. After your treatment period, you will continue to have follow-up appointments to see how you are doing over the long term. The total duration of your participation, including follow-up, will be clearly explained.

Potential risks and benefits

Participating in this study might offer some potential benefits. You would receive a new treatment for your high-risk CLL that might be more effective than existing options, and you would be closely monitored by a team of healthcare professionals. However, there are also potential risks involved. The medications used in the study can have side effects, which can vary from mild to severe, and may be unknown for new drug combinations. The study team will discuss all known potential risks and side effects with you in detail. It's important to remember that you are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (30)

Helios Klinikum Bad Saarow
Verified postcode
Bad Saarow, Germany· Recruiting
DRK Kliniken Berlin Köpenick
Verified postcode
Berlin, Germany· Recruiting
Ev. Diakoniekrankenhaus
Verified postcode
Bremen, Germany· Recruiting
Universitätsklinik Köln
Verified postcode
Cologne, Germany· Recruiting
St. Johannes Hospital
Verified postcode
Dortmund, Germany· Recruiting
Marien Hospital Düsseldorf
Verified postcode
Düsseldorf, Germany· Recruiting
St. Antonius-Hospital
Verified postcode
Eschweiler, Germany· Recruiting
Universitaetsklinikum Essen
Verified postcode
Essen, Germany· Recruiting
Katholisches Krankenhaus Hagen - St. Josefs Hospital
Verified postcode
Hagen, Germany· Recruiting
Universitaetskliniken des Saarlandes
Verified postcode
Homburg, Germany· Recruiting
Klinikum Idar-Oberstein SHG
Verified postcode
Idar-Oberstein, Germany· Recruiting
Staedtisches Klinikum Karlsruhe
Verified postcode
Karlsruhe, Germany· Recruiting

Common questions

What is 'high-risk' CLL?

High-risk CLL means your specific type of leukaemia is more aggressive and harder to treat, often identified by certain genetic changes in the cancer cells.

Are these treatments chemotherapy?

No, both treatment combinations in this study are 'chemo-free,' meaning they use newer types of drugs that work differently from traditional chemotherapy.

How long will the treatment last?

The treatments in this study are for a specific, fixed period of time, not indefinitely. Your study team will tell you the exact duration.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning both you and the study doctors will know which treatment you are receiving.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Barbara Eichhorst, MD, Prof.

barbara.eichhorst@uk-koeln.de +4922147888220 Official trial record

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