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Study on Stopping and Restarting Acalabrutinib in Elderly Patients with Untreated Chronic Lymphocytic Leukemia (CLL)

Verified siteRegistered drugNo placebo

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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 a type of blood cancer called Chronic Lymphocytic Leukemia (CLL) and a similar condition known as Small Lymphocytic Lymphoma (SLL). The study is specifically for elderly patients over 70 years old who have not received treatment for these conditions before. The treatment being investigated is a medication called Acalabrutinib, which is available in two forms: film-coated tablets and hard capsules. Acalabrutinib is a chemical substance that works by targeting specific proteins in cancer cells to stop their growth.

The purpose of this study is to understand if stopping and then restarting Acalabrutinib affects the progression of the disease in frail patients. Participants will take Acalabrutinib for a period, then stop the medication, and later restart it. The study will observe how the disease progresses during this time and whether the treatment helps in maintaining the health of the patients. The trial will also look at the overall survival of patients and their quality of life using a questionnaire.

Throughout the study, the health of the participants will be closely monitored to ensure their safety and to gather information on how effective the treatment is. The trial aims to provide insights into whether this approach can be beneficial for patients with CLL or SLL, especially those who are older and have not been treated before. The study is expected to continue until 2028, allowing researchers to collect comprehensive data on the treatment's impact over time.

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 required to sign an informed consent document. This document confirms that you understand the purpose and procedures of the study and agree to participate.
You will be assessed to ensure you meet the eligibility criteria, which include being over 70 years old, having adequate blood and liver function, and having previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Step 2
Initial treatment phase
You will begin taking the medication acalabrutinib, which is available as Calquence 100 mg film-coated tablets or hard capsules. This medication is taken orally.
The dosage is 100 mg, and you will take it twice daily. This phase will last for 18 months.
Step 3
Treatment discontinuation
After 18 months of treatment, you will stop taking acalabrutinib. This is to assess the effect of discontinuing the medication on your condition.
Your health will be monitored closely during this period to evaluate progression-free survival, which means checking if the disease progresses or remains stable without treatment.
Step 4
Monitoring phase
During the monitoring phase, your condition will be assessed regularly to determine if the disease progresses or if you remain stable.
This phase will last for one year after stopping the medication. Your overall health and quality of life will be evaluated using specific questionnaires.
Step 5
Possible re-treatment
If necessary, based on your condition, you may restart treatment with acalabrutinib. This decision will be made according to specific criteria and reviewed by an independent board.
The response to re-treatment will be assessed to determine the effectiveness of restarting the medication.

Who can join the trial?

12 criteria

Age must be over 70 years old.
Must have adequate blood health: neutrophil count (a type of white blood cell) should be at least 0.75 x 10⁹/L, and platelet count (cells that help with blood clotting) should be at least 50 x 10⁹/L.
Must have adequate liver function: total bilirubin (a substance made by the liver) should be less than 1.5, and liver enzymes aspartate transaminase and alanine transaminase should be no more than 3 times the normal limit, unless related to CLL or a condition called Gilbert’s syndrome.
Must sign an informed consent document to show understanding and willingness to participate in the study.
Must have an ECOG performance status of 2 or less, which means being able to carry out all self-care but unable to carry out any work activities.
Must have previously untreated CLL or SLL.
CLL or SLL must require treatment according to specific criteria from 2018.
Must have a total CIRS score (a measure of health conditions) greater than 6 and/or a creatinine clearance (a measure of kidney function) between 30 and 69 mL/min.
Patients with or without TP53 disruption (a genetic change) can be included.
Patients can be included regardless of their IGHV mutational status (a genetic characteristic).
Patients with controlled heart conditions and/or on certain blood thinners (like novel oral anticoagulants, aspirin, or heparin) can be included. However, those on vitamin K antagonists or dual anti-platelet therapy cannot be included.
Must have a life expectancy of more than 6 months.

Who cannot join the trial?

4 criteria

Patients who are not elderly, meaning they are younger than 70 years old.
Patients who do not have **CLL** (Chronic Lymphocytic Leukemia) or **SLL** (Small Lymphocytic Lymphoma).
Patients who have already received treatment for CLL or SLL.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
CHU Grenoble Alpes
La Tronche, France
Verified
Centre Henri Becquerel
Rouen, France

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Investigated drugs

Acalabrutinib is a medication used in this clinical trial. It is designed to treat patients with chronic lymphocytic leukemia (CLL), a type of cancer that affects the blood and bone marrow. Acalabrutinib works by blocking a specific protein in the body that helps cancer cells grow and survive. In this study, researchers are investigating whether stopping the use of Acalabrutinib after 18 months affects the progression of the disease in patients who have not been treated before. The goal is to see if patients can safely take a break from the medication without the cancer getting worse.

Acalabrutinib

What is already known about the treatment

Acalabrutinib – Acalabrutinib is administered orally in the form of capsules and is currently being studied in clinical trials for its effectiveness in treating elderly patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is a medication that is gaining attention in medical literature for its potential benefits in these conditions. The main therapeutic indication for Acalabrutinib is to manage CLL or SLL, particularly in patients who have not received prior treatment. At the molecular level, Acalabrutinib works by inhibiting a specific protein called Bruton's tyrosine kinase (BTK), which plays a role in the growth and survival of cancer cells. It is classified pharmacologically as a BTK inhibitor, which helps to slow down or stop the progression of the disease.

Investigated diseases

Chronic Lymphocytic Leukemia (CLL) – Chronic Lymphocytic Leukemia is a type of cancer that affects the blood and bone marrow. It typically progresses slowly and is characterized by the accumulation of abnormal white blood cells called lymphocytes. These cells crowd out healthy blood cells, leading to symptoms such as fatigue, swollen lymph nodes, and an increased risk of infections. Over time, the disease can cause anemia and bleeding problems due to the shortage of red blood cells and platelets. As CLL advances, it may spread to other parts of the body, including the liver and spleen. The progression of the disease varies among individuals, with some experiencing a more aggressive form.