AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

Prospective, multicentre, two-arms, I/II phase study to Optimise and Personalise Immunological Therapy of relapsed chronic lymphocytic leukaemia patients (OPTIC)

This research study, called OPTIC, is looking for adults in the UK who have chronic lymphocytic leukaemia (CLL), a type of blood cancer, which has returned. The main goal is to find better and more personalised ways to treat the disease using a combination of medicines already available, such as Venclyxto, Gazyvaro, and in some cases, Darzalex. Researchers want to see if these treatments can get rid of very low levels of cancer cells and improve how patients feel overall. They will be carefully checking for any side effects and looking at how well different treatment plans work for different patients, including considering their quality of life. The study involves different stages (phases 1 and 2) to safely explore these new treatment approaches.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Uniwersytet Medyczny W Lublinie

Enrolment target

Start

29 May 2026

Adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (PBL) with an indication to start treatment of relapsed disease according to IWCLL recommendations.

What is this study about?

This study is called OPTIC, and it's looking into new ways to treat chronic lymphocytic leukaemia (CLL) in adults. CLL is a type of cancer that affects white blood cells. This study is specifically for people whose CLL has come back after previous treatment, and their doctors believe it's time to start treatment again. We know that every person's cancer is slightly different, and what works best for one person might not be ideal for another. That's why this study aims to find the best, most 'personalised' treatment plans.

The researchers are focusing on combinations of medicines that are already approved and used for CLL. These include Venclyxto (venetoclax) and Gazyvaro (obinutuzumab), and in some parts of the study, another medicine called Darzalex (daratumumab). The study is designed to carefully test different ways of using these medicines together. They want to see if these combinations can effectively reduce the cancer cells to very low levels, which is a good sign for long-term health. They'll also be closely monitoring for any side effects and how patients are feeling overall.

Ultimately, this study hopes to figure out which combinations work best for different groups of patients with relapsed CLL. By understanding this, doctors might be able to offer more tailored treatments in the future, leading to better outcomes and an improved quality of life for people living with CLL. It's an important step towards making CLL treatment even more individualised and effective.

Key takeaways

Targets adults with CLL that has come back after previous treatment.
Investigates new combinations of approved CLL medicines (e.g., Venclyxto, Gazyvaro).
Aims to find more personalised and effective treatment plans.
Carefully monitors for side effects and measures treatment effectiveness and quality of life.
Includes regular health checks and assessments.

Who may be eligible?

This study is looking for adults who have a form of blood cancer called chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). You would be considered if your doctor has determined that your cancer has come back after previous treatment and it's now time to start treatment again, following specific medical guidelines.

To join, you must be 18 years old or older. There is no upper age limit, meaning older adults are also welcome to participate if they meet all other criteria. The study welcomes both men and women.

Before you can join, a medical team will review your health and previous treatments to make sure the study is a good fit for you and that taking part would be safe.

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 18 years old or older?
Have you been diagnosed with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)?
Has your CLL or SLL come back after previous treatment?
Has your doctor recommended starting treatment again for your relapsed CLL/SLL?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive one of the specific treatment combinations being tested, which involves existing medicines like Venclyxto, Gazyvaro, and potentially Darzalex. These could be given as tablets or through an infusion (into your vein). The exact schedule for taking medicine and visiting the hospital will depend on which treatment group you are in, but it will involve regular appointments for treatments and check-ups.

During your participation, you will have various tests to monitor your health and how the treatment is working. This will include blood tests and possibly other examinations. You'll also be asked to fill out questionnaires about your quality of life, which helps the researchers understand how the treatment affects your daily living. The total duration of your participation will vary, but you will have ongoing follow-up to monitor your health and the effects of the treatment. The research team will explain the full schedule to you in detail.

Potential risks and benefits

Participating in a clinical trial like OPTIC might offer potential benefits, such as receiving new combinations of treatments for your relapsed CLL under close medical supervision. This could lead to a better control of your cancer or an improved quality of life. However, as with any medical treatment, there are potential risks, including side effects from the medicines, which will be carefully monitored. The study also involves regular hospital visits and tests, which can be time-consuming. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland

Common questions

What is chronic lymphocytic leukaemia (CLL)?

CLL is a type of cancer that starts in white blood cells (called lymphocytes) in your bone marrow, where blood cells are made. It usually grows slowly over many years.

What does 'relapsed' mean?

It means your CLL has returned or started to grow again after you've had treatment for it in the past.

What are Venclyxto, Gazyvaro, and Darzalex?

These are medicines that are already approved and used to treat CLL and similar blood cancers. This study is testing new ways to use them together.

What is the purpose of this study?

The study aims to find the safest and most effective ways to combine existing medicines to treat relapsed CLL, with the goal of personalising treatment for each patient.

Will I know which treatment I'm getting?

Yes, this study is 'open-label,' meaning you and your doctor will know which specific treatment combination you are receiving.