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Study of Acalabrutinib and Rituximab for Elderly Patients with Untreated Mantle Cell Lymphoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Mantle Cell Lymphoma (MCL), a type of cancer that affects the lymphatic system, which is part of the body's immune system. The study involves two treatments: Acalabrutinib, also known by its code name ACP-196, and Rituximab. Acalabrutinib is a type of medication called a BTK inhibitor, which works by blocking a protein that helps cancer cells grow. Rituximab is a medication that targets specific cells in the immune system to help fight cancer.

The purpose of this study is to evaluate how well the combination of acalabrutinib and rituximab works in elderly patients who have not yet received treatment for their mantle cell lymphoma. Participants in the study will receive these medications and will be monitored over time to see how their disease responds. The study will compare the results to previous data from another trial to understand the effectiveness of this treatment combination.

Throughout the study, participants will be regularly assessed to track their progression-free survival, which means the length of time during and after treatment that the patient lives with the disease without it getting worse. Other aspects such as the complete response rate, overall survival, and safety of the treatment will also be evaluated. The study aims to provide valuable insights into the treatment of mantle cell lymphoma in elderly patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and specific health criteria related to mantle cell lymphoma (MCL).
Eligibility criteria include being 60 years or older, having untreated MCL, and meeting certain health standards such as blood counts and kidney function.
Step 2
Treatment initiation
The treatment phase begins with the administration of acalabrutinib and rituximab. Acalabrutinib is taken orally, and the dosage and frequency are determined by the study protocol.
Rituximab is administered according to a schedule that will be explained during the treatment phase. The duration of this treatment is based on the study's objectives and individual response.
Step 3
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and blood work to measure the effectiveness and safety of the medications.
The primary goal is to evaluate progression-free survival, which is the time during and after treatment that the patient lives without the disease worsening.
Step 4
Evaluation of response
At 6 months, a complete response rate is evaluated. This involves determining the extent of disease reduction or remission.
Additional assessments include molecular remission rate and overall response rate, which help in understanding the treatment's impact on the disease.
Step 5
Long-term follow-up
Long-term follow-up is conducted to monitor overall survival and the duration of response. This includes periodic check-ups and tests to ensure continued health and to detect any signs of disease progression.
Safety assessments are also part of this phase, focusing on any adverse effects experienced during the trial.

Who can join the trial?

10 criteria

Must be at least 60 years old.
If a woman can have children and is sexually active, she must use very effective birth control methods during treatment and for a certain time after the last dose of the study drugs.
Must have a confirmed diagnosis of **Mantle Cell Lymphoma (MCL)**, which is a type of cancer, with specific cell characteristics.
The cancer must be at **Stage II-IV**, which means it is measurable by scans and needs treatment according to the doctor.
Must not have had any previous treatment for MCL, except for localized radiation or a short course of steroids to manage symptoms.
Must have an **ECOG performance status** of 0 to 2, which is a scale that measures how well a person can perform daily activities.
Must have a certain level of **neutrophils** (a type of white blood cell) and **platelets** (cells that help with blood clotting), unless these levels are low due to the lymphoma.
Must have a **creatinine clearance** greater than 30 ml/min, which is a measure of kidney function.
Must have **AST** and/or **ALT** (liver enzymes) less than 3 times the upper limit of normal, and **P-bilirubin** (a liver function marker) less than 3 times the upper limit of normal.
Must be able to provide written consent voluntarily, meaning they agree to participate in the study after understanding all the details.

Who cannot join the trial?

2 criteria

Patients who have already received treatment for Mantle Cell Lymphoma (MCL) cannot participate. This means if you have been treated for this type of cancer before, you are not eligible.
Patients who are part of a vulnerable population are not eligible. A vulnerable population includes groups who might be at higher risk of harm or exploitation, such as children or people with certain disabilities.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Helse Bergen HF
Verified
Bergen, Norway
Helse Stavanger HF
Verified
Stavanger, Norway
Region Vaesterbotten
Responsive
Umea, Sweden

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Investigated drugs

Acalabrutinib
is a medication used in this trial to treat patients with mantle cell lymphoma. It works by blocking a specific protein in the body that helps cancer cells grow and survive. This medication is being tested to see if it can help stop the progression of the disease in elderly patients who have not received any previous treatment.
Rituximab
is another medication used in the trial, often given in combination with other cancer treatments. It is a type of therapy that targets specific cells in the immune system, helping to destroy cancer cells. In this study, it is being used alongside acalabrutinib to evaluate its effectiveness in improving the outcomes for patients with untreated mantle cell lymphoma.

Acalabrutinib

What is already known about the treatment

Acalabrutinib
Acalabrutinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating mantle cell lymphoma, particularly in elderly patients who have not received prior treatment. The medication works by inhibiting a specific enzyme called Bruton's tyrosine kinase (BTK), which plays a crucial role in the growth and survival of cancer cells. Acalabrutinib is classified as a targeted therapy, specifically a BTK inhibitor, and is designed to interfere with the molecular pathways that allow cancer cells to proliferate.
Rituximab
Rituximab is administered through intravenous infusion. It is a well-established medication in the treatment of various types of lymphoma, including mantle cell lymphoma, and is being evaluated in combination with acalabrutinib for untreated cases. Rituximab works by targeting a protein called CD20 found on the surface of certain cancerous B cells, leading to their destruction. It is classified as a monoclonal antibody and is used to enhance the immune system's ability to fight cancer cells.

Investigated diseases

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It typically begins in the outer edge of a lymph node, known as the mantle zone. The disease often progresses by spreading to other lymph nodes, bone marrow, and sometimes the spleen or gastrointestinal tract. Patients may experience symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of Mantle Cell Lymphoma can vary, with some cases advancing more rapidly than others.