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RecruitingOBSERVATIONAL

Study of the Use of Venetoclax in Participants With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting

This study is designed to understand how a medicine called venetoclax is used and how well it works for people in the UK living with Chronic Lymphocytic Leukemia (CLL). This isn't a traditional 'trial' where new treatments are tested; instead, it's an observational study, meaning researchers will simply watch and record what happens when doctors prescribe venetoclax as part of standard care. They want to see how effective it is in real-life situations, how it impacts healthcare costs, and importantly, how patients feel and what their experiences are. Venetoclax might be given on its own or with other common CLL medicines like rituximab, obinutuzumab, ibrutinib, or acalabrutinib, exactly as your doctor thinks is best according to established medical guidelines.

At a glance

Status
Recruiting
Sponsor
AbbVie
Enrolment target
500
Start
04 Dec 2017
Estimated completion
01 Dec 2030

What is this study about?

This study is about understanding how a medicine called venetoclax works for people with a specific type of blood cancer called Chronic Lymphocytic Leukemia, or CLL. CLL affects your white blood cells, which are an important part of your body's defence system. When you have CLL, these cells don't work properly and grow out of control.

Unlike studies that test new medicines, this one is 'observational'. This means researchers aren't asking doctors to try anything new or different. Instead, they're simply watching and collecting information on how venetoclax is being used in everyday medical care, exactly as doctors would normally prescribe it. They're interested in whether it's given on its own or with other common CLL treatments, such as rituximab, obinutuzumab, ibrutinib, or acalabrutinib. The main goal is to see how well it works for patients, how it affects their health, what the costs involved are, and most importantly, how patients themselves feel about their treatment outcomes and quality of life.

This kind of study is really important because it gives doctors and researchers a clearer picture of how treatments perform outside of very controlled clinical trials. By looking at 'real-life' experiences, we can learn more about the practical effects of venetoclax for a wider range of people with CLL, helping to improve care for everyone in the future.

Key takeaways

  • This study observes how venetoclax works for CLL patients in real-life care.
  • You'll receive standard treatment as prescribed by your doctor.
  • The study aims to understand treatment effectiveness, costs, and patient experiences.
  • Participation involves sharing medical information and patient-reported outcomes.
  • No experimental treatments are given; it's about learning from existing care.
  • Your decision to join or not will not affect your medical treatment.

Who may be eligible?

To take part in this study, you must be an adult aged 18 or over.

The main requirement is that you have been diagnosed with Chronic Lymphocytic Leukemia (CLL) and that your doctor has decided to start you on venetoclax treatment. This treatment must be prescribed following the standard guidelines and instructions for its use in the UK, often called the 'local label'. It doesn't matter if this is your first treatment for CLL or if you've had other treatments before; as long as your doctor is starting you on venetoclax as a standard part of your care, you could be included.

There are no specific reasons that would prevent you from joining this study if you meet the above criteria. It's designed to be very open to people receiving venetoclax as part of their regular care for CLL.

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.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of Chronic Lymphocytic Leukemia (CLL)?
  3. Has your doctor decided to start you on venetoclax treatment?
  4. Is your venetoclax treatment being prescribed according to standard UK medical guidelines?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's important to know that you won't be asked to do anything differently than what your doctor would normally recommend for your CLL treatment. You'll receive venetoclax (either alone or with other medicines) just as your doctor prescribes it, following standard medical practice.

The research team will simply collect information from your existing medical records. This might include details about your health, how your CLL is responding to treatment, and any side effects you might experience. They will also ask you questions about how you are feeling and the impact of the treatment on your daily life. This information will be collected during your regular clinic visits, so it shouldn't add extra appointments to your schedule.

Because this is an observational study, there's no set total duration for your participation. Researchers will follow your progress for as long as you continue to receive venetoclax and attend your routine appointments, allowing them to gather comprehensive information over time.

Potential risks and benefits

Taking part in this study may not directly benefit you, as you'll be receiving the same treatment your doctor would recommend anyway. However, the information gathered will help improve our understanding of CLL and venetoclax treatment, potentially benefiting future patients. There are no additional risks from participating beyond those associated with your venetoclax treatment itself, as you are not undergoing any extra procedures for the study. You are free to withdraw from the study at any time without affecting your medical care.

Locations (70)

  • Universitaetsklinikum St. Poelten /ID# 221152
    Verified postcode
    Sankt Pölten, Austria· Recruiting
  • Medizinische Universitaet Graz /ID# 221155
    Verified postcode
    Graz, Austria· Completed
  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 221153
    Verified postcode
    Salzburg, Austria· Active not recruiting
  • Hanusch Krankenhaus /ID# 221151
    Verified postcode
    Vienna, Austria· Completed
  • Stauferklinikum Schwaebisch Gmuend /ID# 201518
    Verified postcode
    Mutlangen, Germany· Completed
  • Onkologische Praxis /ID# 201545
    Verified postcode
    Stuttgart, Germany· Completed
  • Schwarzwald-Baar-Klinikum /ID# 208176
    Verified postcode
    Villingen-Schwenningen, Germany· Active not recruiting
  • MVZ am Klinikum Aschaffenburg Onkologie /ID# 201548
    Verified postcode
    Aschaffenburg, Germany· Active not recruiting
  • Studienzentrum Aschaffenburg /ID# 204125
    Verified postcode
    Aschaffenburg, Germany· Active not recruiting
  • Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 200950
    Verified postcode
    Augsburg, Germany· Completed
  • Drs. Tanzer, Chirca, Stoeberl /ID# 202613
    Verified postcode
    Bad Reichenhall, Germany· Completed
  • Internistische Schwerpunktpraxen, Erlangen /ID# 200949
    Verified postcode
    Erlangen, Germany· Completed

Common questions

What is Chronic Lymphocytic Leukemia (CLL)?

CLL is a type of cancer that affects a specific kind of white blood cell, called lymphocytes. These cells are part of your immune system and help fight infection.

What is venetoclax?

Venetoclax is a medicine used to treat CLL. It works by targeting specific proteins in the cancer cells, helping to stop their growth and encourage their death.

Will I get a new or experimental treatment?

No, this study only involves treatments that are already approved and prescribed by your doctor as part of your standard care. You will not receive any experimental medicines.

Do I have to take part?

No, taking part is entirely voluntary. Your decision will not affect your medical care in any way.

What kind of information will you collect?

Researchers will collect information from your medical records about your health, your treatment, and how you feel. This helps them understand how venetoclax works in real-world settings.

How to find out more

Johannes Huelsenbeck

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

Interested in taking part?

Register your interest

Share your details and the research team for "Study of the Use of Venetoclax in Participants With Chronic …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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