Study on Acalabrutinib and R-CHOP for Patients with Diffuse Large B-Cell Lymphoma (DLBCL)

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What is this study about?

This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL). The study is investigating the effectiveness of a treatment that includes a medication called Acalabrutinib, which is also known by its code name ACP-196. This medication is being tested in combination with a standard chemotherapy regimen known as R-CHOP, which is commonly used to treat DLBCL. The trial aims to assess how well this combination works in patients with specific genetic changes, such as the MYD88 L265P and CD79A/B mutations, which are changes in the DNA that can affect how the cancer behaves.

The purpose of the study is to evaluate the effectiveness of the treatment in different groups of patients. Some patients will receive the combination of Acalabrutinib and R-CHOP, while others may receive additional Acalabrutinib treatment or a reduced number of R-CHOP cycles based on their response to the initial treatment. The study will also explore the impact of certain test results, such as PET/CT scans and ctDNA levels, which help in understanding how the cancer is responding to the treatment. PET/CT is a type of imaging test that helps visualize cancer activity in the body, and ctDNA refers to small fragments of DNA from the cancer that are found in the blood.

Participants in the study will follow a treatment plan that may last up to 18 months, depending on their response to the therapy. The study will monitor the progression of the disease and the overall survival of the participants. It will also track any side effects experienced during the treatment. The goal is to find the most effective treatment approach for patients with DLBCL, particularly those with specific genetic mutations, and to improve their chances of recovery.

1 joining the trial

Upon joining the trial, you will be required to provide written informed consent. This means you agree to participate in the study and understand the procedures involved.

2 initial assessments

You will undergo initial assessments to confirm eligibility. These assessments include blood tests, imaging scans like PET/CT, and possibly a biopsy to evaluate your condition.

3 treatment phase

The treatment involves taking acalabrutinib orally. The dosage is 100 mg in the form of film-coated tablets. You will take this medication as directed by the study team.

You will also receive a combination of drugs known as R-CHOP, which includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. The frequency and duration of these medications will be explained by the study team.

4 monitoring and assessments

Throughout the trial, regular monitoring will occur. This includes blood tests and imaging scans to assess your response to the treatment.

You may be asked to provide additional samples for research purposes, which will help in understanding the treatment’s effects.

5 adjustments to treatment

Based on your response, adjustments to your treatment plan may be made. This could involve changes in medication or dosage.

The study team will inform you of any changes and explain the reasons behind them.

6 end of treatment

At the end of the treatment phase, final assessments will be conducted to evaluate the overall response to the therapy.

You will be informed about the results and any further steps that may be necessary.

7 follow-up

After completing the treatment, follow-up visits will be scheduled to monitor your health and any long-term effects of the treatment.

These visits are important to ensure your well-being and to gather additional data for the study.

Who Can Join the Study?

Provide written informed consent before joining the study. This means you agree to participate after understanding the study details.
Have adequate blood clotting function. This means your blood clots normally, with specific test results within a safe range.
If you are a woman who can have children, you must use highly effective birth control, not be pregnant or breastfeeding, and agree not to become pregnant during the study and for 12 months after the last dose of the study drug. A negative pregnancy test is required before joining the study.
If you are a man, agree not to donate sperm or father a child during the study and for 12 months after the last dose of the study drug.
Be able and willing to swallow the study drug as a whole capsule or tablet.
Be willing to participate in translational research projects, which involve studying samples like blood or tissue to understand the disease better.
Have a confirmed diagnosis of treatment-naïve DLBCL (Diffuse Large B-Cell Lymphoma) that meets specific criteria, including being eligible for 6 cycles of a treatment called R-CHOP, having a certain stage of the disease, and having measurable disease activity.
If you had a previous cancer treated with the intent to cure, you can join if the treatment was completed at least 2 years ago and there is no evidence of the disease. Less than 2 years is acceptable for cancers with a low risk of coming back.
Be at least 18 years old.
Have an EGOG performance status of 0-2 (or 3 if due to the disease), which measures your ability to perform daily activities.
Have adequate bone marrow function, meaning your blood cell counts are within a safe range, with some exceptions if the disease affects your bone marrow.
Have adequate liver function, meaning your liver tests are within a safe range, with some exceptions if the disease affects your liver.
Have adequate kidney function, meaning your kidneys are working well enough to filter waste from your blood.
Have adequate heart function, meaning your heart pumps blood well, as shown by a test called echocardiography.

Who Cannot Join the Study?

Patients with other types of cancer that are not disseminated large B-cell lymphoma.
Patients who have not shown a molecular response after two courses of R-CHOP treatment. A molecular response means a significant reduction in cancer markers in the blood.
Patients who have a positive PET/CT scan with a Deauville score of 4 or 5 after two courses of R-CHOP treatment. A PET/CT scan is an imaging test that helps show how the cancer is responding to treatment.
Patients who have not achieved a negative PET/CT scan with a Deauville score of 1-3 after two cycles of R-CHOP treatment.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or attend the required visits.
Patients who are part of a vulnerable population that requires special protection.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country	Status
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Ajljrvy Onqfuvowhtn Psbj Gxnukxae Xkgst	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	29.08.2022

Trial locations

Investigated drugs:

Acalabrutinib

Acalabrutinib is a medication used in this trial to treat a type of cancer called diffuse large B-cell lymphoma (DLBCL). It works by blocking a specific protein in the cancer cells, which helps to stop them from growing and spreading. In this study, acalabrutinib is being tested to see how effective it is when used with other treatments for patients with certain genetic mutations in their cancer.

R-CHOP is a combination of medications used to treat DLBCL. It includes a mix of drugs that work together to kill cancer cells and stop them from multiplying. R-CHOP is a standard treatment for this type of cancer and is being used in the trial to see how well it works with other therapies, like acalabrutinib, in different patient groups.

Rituximab is a medication that targets specific cells in the immune system. It is used to treat certain types of cancer, including DLBCL. In this trial, rituximab is being used as part of the R-CHOP treatment and also as a single agent in some patients. The study aims to explore how effective rituximab is when used alone or in combination with other treatments in different scenarios.

Diffuse Large B-Cell Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It typically presents as a rapidly growing mass, often in the lymph nodes, but it can also occur in other organs. The disease progresses quickly, with symptoms that may include swelling of lymph nodes, fever, night sweats, and weight loss. As it advances, it can spread to other parts of the body, including the bone marrow and central nervous system. The progression of the disease can vary, with some cases remaining localized while others become more widespread. The disease is characterized by its aggressive nature, requiring prompt medical attention.

Trial ID:

2024-516740-26-00

Protocol code:

SAKK 38/19

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Acalabrutinib and R-CHOP for Patients with Diffuse Large B-Cell Lymphoma (DLBCL)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?