Study on Acalabrutinib for Adults with Chronic Lymphocytic Leukemia and Heart Issues

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What is this study about?

This clinical trial is focused on studying the effects of a medication called acalabrutinib, which is used to treat a type of cancer known as Chronic Lymphocytic Leukemia (CLL). The study is specifically looking at patients who have CLL along with moderate to severe heart problems. The purpose of the study is to evaluate the safety and how well patients can tolerate acalabrutinib when used alone, compared to other treatments chosen by doctors.

Participants in the study will receive either acalabrutinib or another treatment selected by their doctor. The study will monitor how patients respond to the treatment over a period of time, which could last up to 72 weeks. The study will also look at how often patients need to stop their treatment due to heart-related issues or other serious side effects. Additionally, the study will track the overall survival of patients, which means the time from starting the study to the time of death from any cause.

The study aims to provide valuable information on the effectiveness and safety of acalabrutinib for patients with CLL and heart problems. By comparing it to other treatments, researchers hope to understand better which option might be more beneficial for these patients. The results could help guide future treatment decisions for people with similar health conditions.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. The patient must provide written consent to participate.

Eligibility criteria include being 18 years or older, having a specific health condition, and meeting certain health parameters.

2 randomization

The patient will be randomly assigned to one of two groups: one receiving acalabrutinib monotherapy and the other receiving the investigator’s choice of treatment.

This process ensures that the assignment is unbiased and that the effects of the treatments can be compared.

3 treatment administration

If assigned to the acalabrutinib group, the patient will take Calquence 100 mg film-coated tablets orally. The dosage and frequency will be determined by the study protocol.

The duration of treatment will be specified in the study protocol, and the patient will be monitored regularly to assess the treatment’s effects.

4 regular monitoring

Throughout the study, the patient will undergo regular health assessments to monitor the treatment’s safety and effectiveness.

These assessments may include physical exams, blood tests, and other evaluations as required by the study protocol.

5 completion of treatment

Upon completing the treatment phase, the patient will undergo a final evaluation to assess the overall response to the treatment.

The study will collect data on the patient’s health outcomes, which will contribute to the study’s findings.

6 follow-up

After the treatment phase, the patient may be required to participate in follow-up visits to monitor long-term health outcomes.

These visits will help gather information on the duration of response and any potential late effects of the treatment.

Who Can Join the Study?

Men and women who are 18 years or older at the time of signing the informed consent.
Have an ECOG performance status of 0 to 3, which is a scale used to assess how a disease affects a patient’s daily living abilities.
Have a left ventricular ejection fraction (LVEF) of less than 50% as measured by an echocardiogram (ECHO). This is a test that checks how well the heart is pumping blood.
Have a diagnosis of Chronic Lymphocytic Leukemia (CLL) according to specific guidelines.
Be either treatment-naïve (have not received treatment before) or relapsed/refractory (the disease has returned or not responded to treatment) and have received no more than 2 prior lines of systemic anti-CLL treatment.
Have active disease that requires treatment according to specific criteria.
Meet certain laboratory parameters:
- Absolute neutrophil count (ANC) of at least 500 cells/μL.
- Platelet count of at least 30,000 cells/μL.
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels no more than 3 times the upper limit of normal.
- Total bilirubin no more than 1.5 times the upper limit of normal, unless due to Gilbert’s syndrome.
- Estimated creatinine clearance of at least 40 mL/min or serum creatinine no more than 2 times the upper limit of normal.
Women and men who are sexually active and can have children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of the study medication.
Must be willing and able to follow the study visit schedule, understand and comply with other study requirements, and provide written informed consent and authorization to use protected health information.

Who Cannot Join the Study?

Patients with other serious health conditions that could interfere with the study.
Patients who have had a different type of cancer in the past, unless it was treated and cured.
Patients who are pregnant or breastfeeding.
Patients who have an active infection that needs treatment.
Patients who have had a heart attack or stroke in the last 6 months.
Patients who are currently participating in another clinical trial.
Patients who have a known allergy to the study medication.
Patients who have a history of drug or alcohol abuse.
Patients who have a mental health condition that could affect their ability to participate in the study.
Patients who have had a major surgery in the last 4 weeks.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Hospital Santa Maria Della Misericordia	Perugia	Italy
Med Polonia Sp. z o.o.	Poznan	Poland
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Pratia S.A.	Skorzewo	Poland
ARNAS G. Brotzu	Cagliari	Italy

Trial status

Country	Status	Recruitment Start
Czechia	Not yet recruiting	30.10.2024
Italy	Recruiting	30.10.2024
Poland	Recruiting	30.10.2024
Spain	Recruiting	30.10.2024

Trial locations

Investigated drugs:

Acalabrutinib

Acalabrutinib is a medication used in this trial as a monotherapy. It is designed to treat adults with chronic lymphocytic leukemia, especially those who have moderate to severe heart problems. The goal is to see how safe and tolerable this medication is for patients who are either new to treatment or have had previous treatments that didn’t work.

Investigator’s Choice of Treatment refers to a selection of treatments chosen by the healthcare provider based on the patient’s specific needs and medical history. This option allows the doctor to use their expertise to decide the best possible treatment for the patient, considering their chronic lymphocytic leukemia and heart condition.

Investigated diseases:

Chronic lymphocytic leukaemia

Chronic Lymphocytic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal white blood cells. These cells accumulate over time, crowding out healthy blood cells and impairing the immune system. The disease often progresses slowly, and many people may not experience symptoms for years. As it advances, symptoms such as fatigue, swollen lymph nodes, and frequent infections may occur. The progression can vary greatly among individuals, with some experiencing a more aggressive form.

Moderate to Severe Cardiac Impairment – This condition involves a significant reduction in the heart’s ability to pump blood effectively, which can lead to symptoms such as shortness of breath, fatigue, and fluid retention. It can result from various underlying heart diseases, including coronary artery disease or heart valve problems. Over time, the heart’s reduced function can affect other organs and lead to complications. The severity of symptoms and progression can vary, with some individuals experiencing a gradual worsening of their condition. Regular monitoring and lifestyle adjustments are often necessary to manage the condition.

Trial ID:

2023-510147-37-00

Protocol code:

D8223C00016

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Acalabrutinib for Adults with Chronic Lymphocytic Leukemia and Heart Issues

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?