AuthorisedTherapeutic exploratory (Phase II)Interventional

A phase II efficacy and safety study of cell-free circulating tumor DNA-guided commencement of second-line treatment in patients with DLBCL/HGBCL relapse

This study is investigating a new way to guide treatment for people whose diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) has returned. It's a 'Phase II' study, which means researchers are checking if a new approach is both safe and works. They're using a special blood test that looks for tiny bits of cancer DNA in the blood to help decide when to start a second round of treatment. The main goal is to see how well patients respond to this guided treatment and to check for any serious side effects. This could lead to more personalised and timely treatment decisions in the future.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Instytut Hematologii I Transfuzjologii

Enrolment target

340

Start

02 Dec 2024

Diffuse large B-cell lymphomas (DLBCL Diffuse large B-cell lymphoma) and aggressive B-cell lymphomas (HGBCL High-grade B-cell lymphoma) originate from mature B-cells at various stages of terminal differentiation

What is this study about?

Imagine you have a type of lymphoma, which is a cancer that starts in certain white blood cells. This study is for two specific kinds: Diffuse Large B-cell Lymphoma (DLBCL) and High-grade B-cell Lymphoma (HGBCL). Sometimes, despite initial treatment, these lymphomas can come back, which doctors call a relapse. When this happens, new treatment is needed.

Currently, doctors often rely on scans and other tests to spot when the lymphoma has returned. This study is exploring a different approach. Researchers are looking at what's called 'cell-free circulating tumour DNA', or cfDNA for short. Think of it like tiny fragments of the cancer's genetic material that can be found floating in your blood. This study is trying to use levels of cfDNA, picked up by a simple blood test, to help decide the best time to start a second line of treatment.

The main aim is to see how well patients respond to this treatment plan – meaning, how much the lymphoma shrinks or disappears – when the decision to start treatment is guided by these cfDNA levels. They also want to carefully track any side effects to make sure the approach is safe. The hope is that this new method could help doctors make more precise and timely treatment decisions for patients in the future.

Key takeaways

This study explores a new way to guide lymphoma treatment decisions using blood tests.
It's for adults with specific types of lymphoma that have returned.
The goal is to see if guiding treatment with cfDNA levels is safe and effective.
Participation involves blood tests, regular check-ups, and various lymphoma medications.
You'll also be asked about your quality of life during the study.
You can stop participating at any time.

Who may be eligible?

This study is for adults, aged 18 or older. It is open to both men and women.

To be considered for this study, you must have been diagnosed with either Diffuse Large B-cell Lymphoma (DLBCL) or High-grade B-cell Lymphoma (HGBCL). Importantly, your lymphoma must have returned, or 'relapsed', after your initial treatment.

There will be other, more detailed health checks to make sure the study is a safe and suitable option for you. Your doctor will be able to discuss all the specific requirements with you.

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 Diffuse Large B-cell Lymphoma (DLBCL) or High-grade B-cell Lymphoma (HGBCL)?
Has your lymphoma returned after your first treatment?
Are you willing to have regular blood tests and medical check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be starting a second line of treatment for your lymphoma. This treatment will involve various medications, which could include capsules or infusions (where medicine is given directly into your vein). The specific medications you receive will depend on what the doctors decide is best for you.

A key part of this study involves regular blood tests to check your cfDNA levels. These results will help guide your treatment decisions. You'll also have regular visits with the study team for health assessments, checks for any side effects, and further investigations like scans, similar to what you might expect during standard cancer treatment. The researchers will also ask you to complete questionnaires about your quality of life, to understand how the treatment affects your daily living. The total duration of your participation will depend on how your treatment progresses and includes a follow-up period to see how you are doing over time.

Potential risks and benefits

Taking part in this study means you might receive treatment carefully tailored using new information from your blood tests. This approach could potentially lead to more effective or better-timed treatment for your lymphoma. However, as with any medical treatment, there are potential risks, including side effects from the medications used. The study team will closely monitor you for any adverse reactions. You will receive detailed information about all potential side effects. Importantly, joining a study is always your choice, and you have the right to withdraw 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
Poland

Common questions

What is a 'Phase II' study?

A Phase II study means researchers are testing if a new treatment approach is safe and effective in a larger group of people, after initial safety checks. It aims to see if it works well enough to continue further research.

What is DLBCL/HGBCL?

These are types of fast-growing cancers that affect white blood cells called B-cells. They are a form of lymphoma, which originates in the body's lymphatic system.

What is 'cfDNA'?

cfDNA stands for cell-free circulating tumour DNA. It's tiny fragments of DNA released by cancer cells that can be found in your blood. Doctors can test for these fragments.

Will I get to choose my medication?

The study involves different available medications for lymphoma. The specific medication you receive will be decided by the study doctors based on your health and the study's plan.

How long will I be in the study?

The total length of time you'll be part of the study will depend on your individual treatment journey and will include a follow-up period. The study team will discuss this in detail with you.