Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Prospective, Open-Label, Multicenter Randomized Phase III Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine and Rituximab (BR) in FIT Patients with previously untreated Chronic Lymphocytic Leukemia (CLL) without DEL(17P) or TP53 Mutation

This important study is looking for people with Chronic Lymphocytic Leukemia (CLL) who haven't had previous treatment for their condition. It aims to see if a newer treatment combining venetoclax and obinutuzumab works better and is safer than the commonly used treatments, FCR or BR. Doctors will be checking to see how well these treatments reduce the tiny amounts of cancer cells that might be left behind after treatment (this is called MRD response). They'll also be looking at how long people stay well, their overall health, and any side effects. This is a "Phase III" study, which means it’s a big study designed to confirm if a new treatment is better than existing ones for patients without specific genetic changes (like DEL(17P) or TP53 mutation).

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

121

Start

29 Jul 2024

Chronic Lymphocytic Leukemia (CLL)

What is this study about?

This study is for adults who have recently been diagnosed with Chronic Lymphocytic Leukemia (CLL) and haven't had treatment for it yet. The main goal of the study is to compare two different ways of treating CLL. One treatment involves a combination of two medicines, venetoclax (also known as Venclexta or Venclyxto) and obinutuzumab (also known as Gazyvaro). The other treatments are standard ones: either fludarabine, cyclophosphamide, and rituximab (often called FCR) or bendamustine and rituximab (often called BR).

The researchers want to find out if the venetoclax and obinutuzumab combination is more effective at getting rid of the very small amounts of cancer cells that might remain after treatment. This is very important because reducing these tiny amounts of remaining cancer cells (called 'minimal residual disease' or MRD) could lead to better long-term outcomes. They'll be checking for these cells in both blood and bone marrow. The study will also carefully look at how safe each treatment is and any side effects that people experience.

Ultimately, this study aims to understand which treatment approach is best for people with newly diagnosed CLL, especially those who don't have certain genetic changes (like DEL(17P) or TP53 mutation) that can affect how well treatments work. Finding more effective and safer treatments can significantly improve the lives of people living with CLL. This study is a Phase III trial, meaning it's a large and important step in potentially changing how CLL is treated.

Key takeaways

This study compares two CLL treatments: a newer combination (venetoclax + obinutuzumab) versus standard (FCR/BR).
It's for adults newly diagnosed with CLL who haven't had previous treatment.
The main goal is to see which treatment best reduces tiny amounts of cancer cells (MRD).
Researchers will also track safety, side effects, and overall health.
This is a large, important 'Phase III' study that could change future CLL treatment.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and have been diagnosed with Chronic Lymphocytic Leukemia (CLL). It's important that you haven't received any treatment for your CLL before beginning this study.

Doctors will also need to check your medical history and run tests to make sure you're healthy enough to take part and that you don't have certain genetic changes in your CLL cells (specifically, DEL(17P) or TP53 mutation). These specific genetic changes can sometimes affect how certain treatments work, so the study is focusing on people without them to ensure the best comparison between the treatments.

Other health conditions or medications you are currently taking might also be considered to ensure your safety in the study. Your medical team will carefully review all of these details with you to see if this study is a good fit.

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 Leukemia (CLL)?
Have you NOT received any treatment for your CLL yet?
Do your doctors believe you do NOT have specific genetic changes (DEL(17P) or TP53 mutation) in your CLL cells?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to receive one of the two treatment approaches: either the combination of venetoclax and obinutuzumab, or one of the standard treatments (FCR or BR). Doctors will regularly check your health through blood tests, physical exams, and sometimes bone marrow samples, to see how the treatment is working and monitor for any side effects. You will have regular visits to the clinic for your treatments and check-ups.

The study will follow your progress over several months, with key assessments at 15 months to see how well the treatments have worked in reducing cancer cells. Even after the main treatment period, you will have follow-up appointments to track your long-term health and any ongoing effects of the treatment. The total duration of your participation, including follow-up, will be explained in detail by the study team, but it will involve a commitment over a significant period.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new and potentially more effective treatment for your CLL or receiving well-established standard treatments under close medical supervision. However, like all medical treatments, there are potential risks, including side effects from the medications. The study team will explain all known side effects and risks to you in detail. You will be closely monitored throughout the study to manage any side effects. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
France
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Unverified
Italy

Common questions

What is CLL?

Chronic Lymphocytic Leukemia (CLL) is a type of cancer that affects specific white blood cells (lymphocytes) in your bone marrow and blood.

What does 'Phase III Study' mean?

Phase III means this is a large study that compares a new treatment with existing standard treatments to confirm if it's better and safer.

What is MRD response?

MRD (Minimal Residual Disease) response means doctors are looking for very tiny amounts of cancer cells that might be left after treatment, even if you feel well.

Will I know which treatment I'm getting?

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

What if I have certain genetic mutations?

This particular study is focusing on people with CLL who do NOT have specific genetic changes called DEL(17P) or TP53 mutation.