Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Multi-Center, Open Label, Uncontrolled, Phase II Clinical Trial Evaluating the Safety and Efficacy of Venetoclax in Combination with Atezolizumab and Obinutuzumab in Richter Transformation of CLL

This research study is looking at a new treatment approach for people with Richter Transformation. This is an aggressive type of cancer that can develop in individuals who have chronic lymphocytic leukemia (CLL). The study is testing a combination of three existing medications: Venclexta, Tecentriq, and Gazyvaro. Doctors want to understand if this combination is safe and if it can effectively shrink the cancer. The main goal is to see if at least 67% of patients respond well to the treatment after six cycles. Researchers will carefully monitor patients for any side effects and for how long the treatment keeps the cancer under control. It's a Phase II study, meaning it's an early-stage trial focusing on both safety and effectiveness.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

ASST Grande Ospedale Metropolitano Niguarda

Enrolment target

Start

04 Nov 2024

Richter syndrome of chronic lymphocytic leukemia

What is this study about?

This study is a clinical trial, which means it's a carefully planned medical research study involving people. The main purpose of this study is to investigate a new way of treating a condition called Richter Transformation. Richter Transformation is an aggressive type of cancer that can develop in some people who have chronic lymphocytic leukemia, also known as CLL.

The study is testing a combination of three different medicines that are already available: Venclexta, Tecentriq, and Gazyvaro. Doctors believe that using these medicines together might be more effective than using them alone. They want to find out how safe this combination is and how well it works to reduce or control the cancer in patients with Richter Transformation. This is an early-stage study, called a Phase II trial, which means researchers are actively exploring how well the treatment works and what side effects it might have.

The main question this study hopes to answer is whether at least 67% of patients will see their cancer shrink or improve after about six treatment cycles. Doctors will carefully measure how patients respond using special guidelines for aggressive cancers. They will also keep a close eye on any side effects and check how long the treatment continues to help patients. Even if some CLL cells remain, if the Richter Transformation responds completely, it will be considered a success for this part of the treatment.

Key takeaways

Tests a new medicine combination for Richter Transformation.
Aims to see if the treatment shrinks cancer effectively.
Monitors for safety and side effects very closely.
Early-stage study (Phase II) focusing on effectiveness.
Open to adults 18 and over with Richter Transformation.

Who may be eligible?

To join this study, you must be at least 18 years old, and the study is open to both men and women. The most important requirement is that you have Richter Transformation linked to chronic lymphocytic leukemia (CLL).

There might be other health requirements or conditions that would prevent you from joining, which the study doctors would review with you. For example, they might need to check your overall health and how well your organs are working.

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?
Do you have a diagnosis of Richter Transformation?
Is your Richter Transformation linked to CLL?
Are you male or female?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the treatment combination of Venclexta, Tecentriq, and Gazyvaro. The study doctors and nurses would explain exactly how these medicines are given, which may involve infusions (given through a drip) or tablets.

You would have regular appointments at the hospital or clinic. During these visits, doctors would perform examinations, take blood samples, and might carry out scans to see how your body is responding to the treatment and to check for any side effects. They will closely follow your health throughout the treatment period. The study will continue as long as the treatment is helping you and is safe, followed by a period where doctors continue to check on your health even after treatment stops.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new combination treatment for your condition that might be more effective than current options. However, as with any medical treatment, there are potential risks, including side effects from the medicines. The study team will closely monitor you for any side effects and will explain all known risks. Your safety is a priority. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future 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
Italy

Common questions

What is Richter Transformation?

Richter Transformation is when chronic lymphocytic leukemia (CLL), which is usually slow-growing, changes into a more aggressive type of lymphoma (a cancer of the immune system).

What kind of medicines are being tested?

The study is testing a combination of three medicines: Venclexta, Tecentriq, and Gazyvaro. These are used to treat certain cancers and work in different ways.

What does 'Phase II' mean?

Phase II trials are early studies that look at how safe a new treatment is and how well it works. They often involve a small number of patients.

Will I get a placebo (dummy treatment)?

No, this study is 'open-label' and 'uncontrolled,' meaning everyone in the study will receive the active combination treatment, and there is no placebo group.

How long will I be in the study?

The treatment phase will continue for as long as it's helping you and is safe, potentially for at least six cycles. After that, doctors will continue to monitor your health for a longer period.