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

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What is this study about?

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.

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).

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oncopole Claudius Regaud Toulouse France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier D Avignon Avignon France
Centre Henri Becquerel Rouen France
Centre Hospitalier Sud Francilien Corbeil Essonnes France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier De La Cote Basque Bayonne France
Hopital NOVO Pontoise France
Centre Hospitalier Bretagne Atlantique Vannes France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace Mulhouse France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Groupement Des Hopitaux De L’Institut Catholique De Lille lomme France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
12.11.2021

Trial locations

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.

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.

Trial ID:
2024-513936-80-00
Trial Phase:
Therapeutic exploratory (Phase II)

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