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Study Comparing Nemtabrutinib, Ibrutinib, and Acalabrutinib for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic 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 two related diseases: Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). These are types of cancer that affect a part of the immune system called lymphocytes, which are a type of white blood cell. The study is testing a new treatment called Nemtabrutinib, which is taken as a tablet. The purpose of the study is to compare the effectiveness of Nemtabrutinib with other treatments that are already used for these diseases, specifically Ibrutinib and Acalabrutinib. These medications are also taken orally and work by targeting specific proteins in cancer cells to stop them from growing.

Participants in the study will be randomly assigned to receive either Nemtabrutinib or one of the other treatments, Ibrutinib or Acalabrutinib, as chosen by the study doctor. The study will last for a period of time during which participants will take the medication and have regular check-ups to monitor their health and the progress of the disease. The study aims to see how well Nemtabrutinib works compared to the other treatments in terms of how long patients live without the disease getting worse and how many patients respond to the treatment.

Throughout the study, the safety of the participants will be closely monitored, and any side effects will be recorded. The study will also look at how long the benefits of the treatment last and how it affects the overall survival of the participants. This research is important to find better ways to treat CLL and SLL and to improve the quality of life for people living with these conditions.

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
Joining the study
Upon joining the study, you will be randomly assigned to receive either nemtabrutinib or a comparator medication, which could be ibrutinib or acalabrutinib. This assignment is random to ensure fairness and accuracy in the study results.
You will be informed about the medication you will receive and its potential effects. This is an important step to ensure you understand the treatment process.
Step 2
Medication administration
If you are assigned to nemtabrutinib, you will take it in the form of a tablet. The dosage and frequency will be explained to you by the study team.
If you are assigned to ibrutinib or acalabrutinib, you will also take it in tablet form. The study team will provide specific instructions regarding dosage and frequency.
Step 3
Regular check-ups
Throughout the study, you will have regular check-ups to monitor your health and the effects of the medication. These check-ups are crucial to ensure your safety and the effectiveness of the treatment.
During these visits, you may undergo various tests and assessments as part of the study protocol.
Step 4
Reporting side effects
It is important to report any side effects or changes in your health to the study team immediately. This information helps in understanding the safety of the medication.
The study team will provide guidance on how to manage any side effects you may experience.
Step 5
Completion of the study
At the end of the study, you will have a final assessment to evaluate the overall impact of the treatment.
The study team will discuss the results with you and provide any necessary follow-up care or recommendations.

Who can join the trial?

8 criteria

Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and active disease that clearly needs treatment.
Has at least one marker showing the presence of the disease.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before starting the study. This is a scale used to assess how the disease affects daily living abilities, where 0 means fully active and 2 means capable of all self-care but unable to carry out any work activities.
Can swallow and keep down oral medication.
If positive for hepatitis B, must have received antiviral treatment for at least 4 weeks and have an undetectable viral load before starting the study.
If there is a history of hepatitis C infection, the viral load must be undetectable at the time of screening.
If living with HIV, must meet all other eligibility criteria.
Open to both male and female participants.

Who cannot join the trial?

10 criteria

Patients who have had previous treatment for **Chronic Lymphocytic Leukemia (CLL)** or **Small Lymphocytic Lymphoma (SLL)** cannot participate.
Patients with any other type of cancer that requires treatment are not eligible.
Patients with serious heart problems, such as heart failure or irregular heartbeats, cannot join the study.
Patients with uncontrolled high blood pressure are excluded.
Patients with active infections that require treatment with antibiotics, antivirals, or antifungals are not eligible.
Patients who have had a stroke or a heart attack in the past 6 months cannot participate.
Patients with severe liver disease are excluded from the study.
Patients who are pregnant or breastfeeding cannot join the study.
Patients who are participating in another clinical trial are not eligible.
Patients with known allergies to the study drugs or similar drugs cannot participate.

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Verified sites

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

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Hospital Clinic De Barcelona
Barcelona, Spain
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Hospital Costa del Sol
Marbella, Spain
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Hospital Universitario De Canarias
La Laguna, Spain

Trial locations

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Investigated drugs

Nemtabrutinib
is a medication being studied for its potential to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It works by targeting specific proteins in cancer cells, which may help to stop their growth and spread. This medication is being compared to other treatments to see if it is more effective in managing these types of blood cancers.
Ibrutinib
is a medication used to treat certain types of blood cancers, including chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It works by blocking a protein that helps cancer cells grow and divide. By doing this, ibrutinib can help slow down or stop the progression of the disease.
Acalabrutinib
is another treatment option for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Similar to ibrutinib, it targets a specific protein in cancer cells, which can help to prevent the cancer from growing and spreading. This medication is being compared to others to determine its effectiveness in treating these conditions.

What is already known about the treatment

Nemtabrutinib
Nemtabrutinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating untreated Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). The main therapeutic indication for nemtabrutinib is to improve the overall response rate and progression-free survival in patients with these conditions. At the molecular level, nemtabrutinib works by inhibiting a specific protein that helps cancer cells grow and survive, thereby slowing down or stopping the progression of the disease. It is classified as a Bruton's tyrosine kinase (BTK) inhibitor, a type of targeted cancer therapy.
Ibrutinib
Ibrutinib is taken orally in capsule form and is an established treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). It is widely recognized in medical literature for its role in managing these conditions. Ibrutinib works by blocking a protein called Bruton's tyrosine kinase (BTK), which is essential for the survival and proliferation of cancer cells. This action helps to slow down the progression of the disease. It belongs to the pharmacological class of BTK inhibitors, which are targeted therapies designed to interfere with specific pathways in cancer cells.
Acalabrutinib
Acalabrutinib is administered orally in capsule form and is used in the treatment of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). It is recognized in the medical community for its effectiveness in these conditions. Acalabrutinib functions by inhibiting the Bruton's tyrosine kinase (BTK) protein, which plays a crucial role in the growth and survival of cancer cells, thereby helping to control the disease. It is classified as a BTK inhibitor, a type of targeted therapy that specifically targets cancer cell pathways.

Investigated diseases

Small Lymphocytic Lymphoma (SLL)
Small Lymphocytic Lymphoma is a type of non-Hodgkin lymphoma characterized by the presence of small, mature-appearing lymphocytes. It primarily affects the lymph nodes and is closely related to Chronic Lymphocytic Leukemia (CLL), differing mainly in the location of cancerous cells. In SLL, the cancer cells are mostly found in the lymph nodes, whereas in CLL, they are primarily in the blood and bone marrow. The disease progresses slowly, with lymph nodes becoming enlarged over time. Patients may experience fatigue, night sweats, and weight loss as the disease advances. The progression can lead to a compromised immune system, making individuals more susceptible to infections.
Chronic Lymphocytic Leukemia (CLL)
Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of abnormal white blood cells called lymphocytes. These cancerous cells accumulate slowly over time, crowding out healthy blood cells and impairing normal immune function. CLL often progresses gradually, with many individuals experiencing no symptoms in the early stages. As the disease advances, symptoms such as fatigue, swollen lymph nodes, and frequent infections may occur. The accumulation of cancerous cells can also lead to anemia and thrombocytopenia, which is a low platelet count. Over time, the disease can cause significant disruption to the body's ability to fight infections and maintain normal blood cell levels.