Study of Acalabrutinib Alone or with Rituximab for Patients with Relapsed/Refractory Marginal Zone Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called B-cell Non-Hodgkin Lymphoma, specifically a subtype known as Relapsed/Refractory marginal zone lymphoma. The study is investigating the effects of a medication called Acalabrutinib, which is available in two forms: hard capsules and film-coated tablets. Acalabrutinib is being tested alone and in combination with another medication called Rituximab. The purpose of the study is to understand how well these treatments work in patients with this type of lymphoma.

Participants in the study will receive either Acalabrutinib alone or in combination with Rituximab. The study will monitor the response of the lymphoma to these treatments over time. This involves regular check-ups and assessments to see how the disease is responding to the medication. The study is designed to gather information on the effectiveness and safety of the treatments, including any side effects that may occur.

The trial is open-label, meaning both the researchers and participants know which treatment is being administered. The study will continue until the estimated end date in 2028, allowing researchers to collect comprehensive data on the long-term effects of the treatments. Participants will be closely monitored throughout the study to ensure their safety and to gather detailed information on the impact of the treatments on their lymphoma.

1 introduction to the trial

Upon joining the study, you will receive detailed information about the trial, including its purpose, procedures, and potential risks and benefits. You will be asked to provide signed and dated informed consent, confirming your understanding and willingness to participate.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, medical history, and previous treatments for marginal zone lymphoma (MZL). A physical examination and imaging tests, such as a CT scan, will be performed to measure any lymphadenopathy or extranodal lymphoid malignancy.

3 treatment phase

You will begin treatment with acalabrutinib, which is available as either 100 mg hard capsules or film-coated tablets. This medication is taken orally. The specific dosage and frequency will be determined by the study protocol and your healthcare provider.

In some cases, acalabrutinib may be combined with another medication called rituximab. Your healthcare provider will inform you if this combination therapy is applicable to your treatment plan.

4 monitoring and follow-up

Throughout the trial, regular monitoring will be conducted to assess your response to the treatment. This includes recording any adverse events (AEs) or serious adverse events (SAEs), as well as conducting blood tests to check hematology, serum chemistry, and immune cell counts.

Your vital signs will be measured, and your performance status will be evaluated using the Eastern Cooperative Oncology Group (ECOG) scale, which assesses your ability to perform daily activities.

5 end of treatment

At the end of the treatment phase, a final assessment will be conducted to evaluate the overall response rate (ORR) to the therapy, as well as the duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

You will be informed about the results and any further steps or follow-up care that may be necessary.

Who Can Join the Study?

Men and women who are 18 years of age or older.
Must have a confirmed diagnosis of marginal zone lymphoma (MZL), which includes different types such as splenic, nodal, and extranodal.
Must have received at least one previous treatment for MZL, which could include:
- For Cohort 1: At least one treatment that targets a protein called CD20, either alone or with other treatments, and the treatment did not work well enough or the disease got worse after the last treatment.
- For Cohort 2: At least one previous treatment for MZL or radiation therapy, and the treatment did not work well enough or the disease got worse after the last treatment.
Must have measurable disease, meaning there is a lymph node or other area affected by the disease that can be measured by a CT scan. This area should be at least 2.0 cm in one direction and 1.0 cm in another direction.
Must have an ECOG performance status of 0, 1, or 2. This is a scale that helps doctors understand how well a person can perform daily activities. A score of 0 means fully active, 1 means some symptoms but almost fully active, and 2 means unable to work but can take care of themselves.
Must be able to understand the purpose and risks of the study and be willing to sign a consent form to participate.

Who Cannot Join the Study?

Patients who have a different type of cancer other than relapsed/refractory marginal zone lymphoma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a serious infection or other severe medical condition that could interfere with the study cannot participate.
Patients who have had a recent heart attack or have severe heart disease cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have had an allergic reaction to similar medications in the past cannot participate.
Patients who have a history of drug or alcohol abuse cannot participate.
Patients who have a mental health condition that could interfere with their ability to follow the study procedures cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Amjkzhu Oybuckwkfgf Ofguynxu Rkvrclr Vrkwz Sbhub Cakcpyae	Palermo	Italy
Auynwxv Uhrnb Sfgsrejdd Ltehyy Dk Bhsfutg	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	29.10.2020

Trial locations

Investigated drugs:

Acalabrutinib

Acalabrutinib is a medication used in this clinical trial to treat a type of cancer called B-cell Non-Hodgkin Lymphoma. It works by blocking a specific protein in the body that helps cancer cells grow. By stopping this protein, acalabrutinib can help slow down or stop the growth of cancer cells.

Rituximab is another medication used in this trial, often in combination with acalabrutinib. It is a type of therapy that targets specific cells in the immune system. Rituximab attaches to these cells and helps the body’s immune system destroy them. This can be helpful in treating certain types of cancer, like B-cell Non-Hodgkin Lymphoma, by reducing the number of cancerous cells in the body.

Relapsed/Refractory Marginal Zone Lymphoma – This is a type of non-Hodgkin lymphoma that affects the marginal zone of lymphoid tissue. It occurs when the disease returns after treatment (relapsed) or does not respond to treatment (refractory). The disease typically progresses slowly, starting in the lymph nodes and potentially spreading to other parts of the body, including the spleen and bone marrow. Symptoms may include swollen lymph nodes, fatigue, and weight loss. As the disease advances, it can lead to more severe symptoms due to the involvement of various organs. The progression can vary significantly among individuals, with some experiencing a more indolent course and others facing a more aggressive form.

Trial ID:

2023-509350-63-00

Protocol code:

ACE-LY-003

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Acalabrutinib Alone or with Rituximab for Patients with Relapsed/Refractory Marginal Zone Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?