Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare the Efficacy and Safety of a Combined Regimen of Obinutuzumab and Venetoclax (GDC-0199/ABT-199) Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients with CLL and Coexisting Medical Conditions

This research study is for people with chronic lymphocytic leukaemia (CLL) who haven't started treatment yet and also have other health conditions. It's a 'Phase 3' study, which means it's one of the final stages of testing a new treatment combination. The study wants to see if a combination of two medicines, obinutuzumab and venetoclax (also known as Venclexta/Venclyxto), is more effective and safer than the current standard treatment, which is obinutuzumab and chlorambucil. Researchers will compare how long patients live without their CLL getting worse and look at side effects. The goal is to find better ways to help people manage their CLL.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

267

Start

30 Nov 2023

Chronic Lymphocytic Leukemia (CLL)

What is this study about?

This study is a clinical trial designed specifically for people in the UK who have Chronic Lymphocytic Leukaemia, or CLL. CLL is a type of cancer that affects white blood cells. This particular study is for patients who haven't had treatment for their CLL yet and also have other health problems that might make some treatments unsuitable. The main purpose is to compare two different treatment approaches.

One treatment arm will receive a combination of medicines called obinutuzumab (also known as Gazyvaro) and venetoclax (also known as Venclexta or Venclyxto). The other group will receive obinutuzumab and chlorambucil. Chlorambucil is a more traditional chemotherapy drug. By comparing these two approaches, doctors want to find out if the newer combination is better at controlling the leukaemia, helps patients live longer without their disease getting worse, and if it has different side effects.

This is a 'Phase 3' study, which is the final stage of testing a new treatment before it can be approved for wider use. This means that the treatments being tested have already shown promise in earlier research. The results of this study will help doctors understand the best way to treat CLL in patients who are newly diagnosed and have other health conditions.

Key takeaways

Compares two CLL treatments: a new combination vs. a standard option.
For newly diagnosed CLL patients with other health conditions.
Aims to find more effective and safer treatments for CLL.
It's a large-scale, final-stage research study (Phase 3).
You would be randomly assigned to one of the two treatment groups.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. Both men and women can take part.

You must have chronic lymphocytic leukaemia (CLL) and importantly, you should not have received any previous treatment for your CLL. The study is also specifically looking for people who have other health conditions alongside their CLL.

The research team will have a full list of suitability requirements. They will check your medical history, current health, and specific CLL details to make sure this study is the right fit for you. It's important to discuss all your health conditions and medications with the study team.

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)?
Have you NOT received any treatment for your CLL yet?
Do you have other health conditions alongside your CLL?
Are you willing to potentially receive either of the two study treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two treatment groups – like flipping a coin, neither you nor your doctor chooses which group you're in. One group gets the obinutuzumab and venetoclax combination, and the other gets obinutuzumab and chlorambucil.

You would receive your medication either through an infusion (into a vein) or as tablets, depending on the treatment group. You would have regular visits to the hospital for checks, blood tests, and to receive your treatment. These visits are important for the doctors to monitor how you're responding to the treatment and to keep an eye on any side effects.

The study would involve regular assessments, including tests to see how your leukaemia is responding. After the main treatment period, there would be follow-up appointments to continue monitoring your health and the long-term effects of the treatment. The total duration of your participation would involve the treatment period and then a longer period of follow-up visits.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from a new treatment that could be more effective or have fewer side effects than current options. However, there's no guarantee the treatment will work for you, and there could be unknown side effects. The treatments involved can have side effects, which the study team will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (11)

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

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Unverified
Bulgaria
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Unverified
Estonia
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Unverified
Romania
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Unverified
France
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Unverified
Spain
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Unverified
Denmark
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Unverified
Croatia
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Unverified
Germany
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Unverified
Austria
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Unverified
Italy
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Unverified
Poland

Common questions

What is CLL?

CLL stands for Chronic Lymphocytic Leukaemia. It's a type of cancer that affects a specific kind of white blood cell, called lymphocytes, which are important for your immune system.

What does 'Phase 3' mean for a study?

Phase 3 is one of the last steps in testing a new treatment. It means the treatment has already shown promise in earlier studies, and now doctors are comparing it to existing treatments on a larger number of patients.

Will I get the new treatment?

This study involves two treatment groups. You would be randomly assigned to one, meaning you have an equal chance of receiving either the new combination or the standard treatment.

What are 'coexisting medical conditions'?

This simply means you have other health issues alongside your CLL, like heart problems or diabetes. The study is designed to be suitable for people with these additional conditions.

Can I stop participating if I want to?

Yes, absolutely. You are free to leave the study at any time, for any reason. Your decision will not affect the medical care you receive.