Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A prospective multicenter phase 2 study of copanlisib in combination with rituximab and CHOP chemotherapy (COPA-R-CHOP) in patients with previously untreated diffuse large B-cell lymphoma (DLBCL)

This study is testing a new way to treat diffuse large B-cell lymphoma (DLBCL), a type of cancer that affects a specific type of white blood cell. Doctors are combining a new drug called BAY 80-6946 with a common chemotherapy treatment (R-CHOP) that includes medicines like Doxorubicin, Cyclophosphamide, Rituximab, and Prednisone. This is a Phase 2 study, which means it's an early stage where researchers are mainly interested in finding the right dose of the new drug, understanding how safe the combination treatment is, and seeing how well it works. The study will look at how many patients are still alive and cancer-free after two years, and will carefully track any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitaetsklinikum Muenster AöR

Enrolment target

Start

17 Sep 2024

Diffuse large B-cell lymphoma (DLBCL)

What is this study about?

This study, called COPA-R-CHOP, is designed to find better ways to treat adult patients who have recently been diagnosed with diffuse large B-cell lymphoma (DLBCL). DLBCL is a type of cancer that starts in white blood cells called lymphocytes and can be quite aggressive. While current treatments are often very effective, doctors are always looking for new and improved options, especially for people who might not respond as well to standard care.

The main idea behind this study is to combine a new drug, called BAY 80-6946 (also known as copanlisib), with a standard chemotherapy treatment regimen called R-CHOP. R-CHOP is made up of several powerful medicines, including Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, and Prednisone. BAY 80-6946 works differently from these other drugs, and the hope is that by adding it to R-CHOP, the treatment will be more effective at fighting the cancer.

Because this is a Phase 2 study, the researchers are particularly focused on two main things. First, they want to find the safest and most effective dose of BAY 80-6946 to use alongside R-CHOP. They will carefully monitor the first few patients to determine this. Second, they want to see how well the combined treatment works over two years, specifically looking at how many patients remain cancer-free. They will also keep a close eye on any side effects to make sure the treatment is as safe as possible.

Key takeaways

Tests a new drug (BAY 80-6946) with standard R-CHOP chemotherapy.
For newly diagnosed diffuse large B-cell lymphoma (DLBCL) in adults.
Aims to find the best dose and check safety and effectiveness.
Patients will be carefully monitored for side effects.
Focuses on how many patients are cancer-free after two years.

Who may be eligible?

To join this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you would need to have been recently diagnosed with diffuse large B-cell lymphoma (DLBCL) and not have received any previous treatment for it. This study is specifically for people whose cancer has just been found and who are starting their very first course of treatment for DLBCL.

There will be other detailed medical checks to ensure this study is safe and appropriate for you, as is standard practice for any clinical trial. Your doctor will be able to explain all the specific requirements.

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 diffuse large B-cell lymphoma (DLBCL)?
Have you NOT received any previous treatment for DLBCL?
Are you comfortable with receiving a new, investigational drug along with standard chemotherapy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new drug BAY 80-6946 along with the standard R-CHOP chemotherapy. The treatment would likely involve regular hospital visits for drug administration and check-ups. You would have visits with the study team to monitor your health, discuss any side effects, and undergo various tests like blood tests, scans, and possibly other procedures to see how the treatment is working and how you are tolerating it. The study will closely track your progress for at least two years to see the long-term effects of the treatment. The total duration of your involvement could extend beyond the treatment period for follow-up appointments.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving a new combination therapy that could be more effective than standard treatment for your diffuse large B-cell lymphoma, especially as it's a new approach. However, as with any new treatment, there are potential risks, including side effects from the new drug and the chemotherapy. The study team will carefully monitor you for any adverse effects. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Germany

Common questions

What is diffuse large B-cell lymphoma (DLBCL)?

DLBCL is a fast-growing cancer that affects a type of white blood cell called B-lymphocytes, which are part of your immune system.

What is R-CHOP chemotherapy?

R-CHOP is a standard combination of drugs used to treat DLBCL. It includes Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone.

What is BAY 80-6946?

BAY 80-6946, also known as copanlisib, is a new drug being tested in combination with R-CHOP to see if it improves treatment for DLBCL.

What does 'Phase 2 study' mean?

Phase 2 studies are early-stage trials that mainly focus on finding the right dose, checking safety, and seeing how well a new treatment works before it's tested on more people.

Will I get the new drug or a placebo?

In this specific study, all participants will receive BAY 80-6946 along with the standard R-CHOP chemotherapy. There is no placebo group for the new drug.