HOVON 139 CLL: A prospective, open-label, multicenter randomized phase-II trial to evaluate the efficacy and safety of a sequential regimen of Gazyvaro (obinutuzumab) followed by obinutuzumab and venetoclax, followed by either standard venetoclax maintenance or MRD guided venetoclax maintenance in first-line patients with CLL and unfit for FCR-like regimens. (GIVE trial).
This study, called the GIVE trial, is for people in the UK recently diagnosed with chronic lymphocytic leukaemia (CLL) who aren't suitable for common chemotherapy treatments. Researchers are testing a combination of two medicines: obinutuzumab (also known as Gazyvaro) and venetoclax. The study aims to see how effective this treatment is, focusing on whether it can make the cancer undetectable in the bone marrow after a certain period. They also want to understand if different ways of continuing venetoclax (either standard dosing or guided by whether cancer cells are still present) make a difference. The trial will also look at side effects, quality of life, and why some people respond better than others, helping to improve future treatments for CLL.
At a glance
What is this study about?
This study, called the GIVE trial, is investigating a new way to treat chronic lymphocytic leukaemia (CLL), a type of blood cancer. It's specifically for people who are newly diagnosed and whose doctors don't recommend a strong chemotherapy treatment called FCR.
The research combines two different medicines. First, you'd receive obinutuzumab (also known as Gazyvaro) on its own. Then, you'd get a combination of obinutuzumab and venetoclax. After this initial treatment, the study looks at two different ways of continuing venetoclax – either a standard approach or one where the venetoclax is guided by whether tiny amounts of cancer cells can still be found in your bone marrow. The main goal is to see if this treatment can make the cancer undetectable in your bone marrow after up to two years of venetoclax.
Ultimately, this research aims to find more effective and gentler treatments for CLL, especially for people who might not cope well with traditional chemotherapy. By understanding how these medicines work, their side effects, and why they help some people more than others, doctors hope to improve care for CLL patients in the future.
Key takeaways
- This study is testing a new way to treat chronic lymphocytic leukaemia (CLL) using two medicines: obinutuzumab and venetoclax.
- It's for newly diagnosed adults with CLL who cannot have standard chemotherapy.
- The main goal is to see if the treatment can make the cancer undetectable.
- It also looks at side effects, quality of life, and why treatments work differently for people.
- Participation involves regular visits and careful monitoring by your medical team.
- You can stop participating at any time if you change your mind.
Who may be eligible?
This study is looking for adults who have been diagnosed with chronic lymphocytic leukaemia (CLL) for the first time. You must be at least 18 years old, and there's no upper age limit.
An important part of who can join is whether you're considered fit enough for certain strong chemotherapy treatments. If your doctor believes you're not suitable for these common chemotherapy options (like FCR-like regimens), then this study might be for you.
Your medical team will carefully review your health and specific CLL details to see if you meet all the necessary requirements to participate safely in this trial.
- Are you 18 years old or older?
- Have you recently been diagnosed with chronic lymphocytic leukaemia (CLL)?
- Has your doctor said you're not suitable for certain strong chemotherapy treatments?
- Are you able to attend regular appointments for treatment and check-ups?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you would first receive a medicine called Gazyvaro (obinutuzumab) through a drip. Following this, you would receive both Gazyvaro and another medicine called venetoclax. After this initial treatment phase, you would continue with venetoclax, either on a regular schedule or at a dose that is adjusted based on whether any remaining cancer cells can be found in your bone marrow. This venetoclax treatment is planned to last for up to 24 cycles (roughly two years). Throughout the study, you would have regular hospital visits for assessments, blood tests, and to monitor how you're feeling and how the treatment is working. This would also involve checking your bone marrow to see if the cancer is detectable.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What is CLL?
CLL stands for chronic lymphocytic leukaemia. It's a type of slow-growing cancer that affects white blood cells in your body.
What are Gazyvaro and venetoclax?
Gazyvaro (obinutuzumab) and venetoclax are medicines used to treat CLL. Gazyvaro helps your immune system find and kill cancer cells, while venetoclax targets a protein that helps cancer cells survive.
What does 'MRD negative' mean?
'MRD negative' means that tests can't find any remaining cancer cells in your bone marrow, even at very low levels (Minimal Residual Disease).
Why is this study important?
This study is looking for new, gentler ways to treat CLL, especially for people who can't have strong chemotherapy, aiming to find treatments that are both effective and have fewer side effects.
Will I have to pay to be part of the study?
No, you will not have to pay for the study treatment or for taking part in the trial itself.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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