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Study of Ibrutinib for Patients with Chronic Lymphocytic Leukemia and TP53 Mutations

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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 Chronic Lymphocytic Leukemia (CLL), a type of cancer that affects the blood and bone marrow. The study is specifically looking at patients with CLL who have certain genetic changes called TP53 aberrations. These changes can affect how the disease progresses. The treatment being tested in this study is a medication called ibrutinib, which is taken orally. Ibrutinib is designed to help manage CLL by targeting specific pathways in cancer cells.

The purpose of the study is to understand how the genetic makeup of the cancer cells changes over time in patients with CLL who have these TP53 mutations. Participants in the study will receive ibrutinib as their first treatment for CLL. The study will monitor the patients at various time points, starting from the beginning of the treatment and continuing at weeks 2, 4, 12, 24, 48, 72, and 96, and then every year until the study ends or the disease progresses.

Throughout the study, researchers will observe how the size of the TP53 mutated subclones, which are small groups of cancer cells with these specific mutations, changes in response to the treatment. This information will help in understanding the effectiveness of ibrutinib in managing CLL with TP53 aberrations and may provide insights into better treatment strategies for this condition in the future.

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
Participation begins after meeting specific criteria, including being 18 years or older, having a documented diagnosis of chronic lymphocytic leukemia (CLL), and showing progressive disease that requires treatment.
Eligibility also requires a negative test for certain viral infections and, for some participants, evidence of a small subclone carrying a TP53 deletion.
Step 2
Baseline assessment
Initial assessments are conducted to establish a baseline for the study. This includes evaluating the size of the TP53 mutated subclone using specific tests.
Step 3
Treatment with <b>ibrutinib</b>
Ibrutinib is administered orally. The dosage and frequency are determined by the study protocol and are designed to treat CLL effectively.
The treatment aims to observe changes in the clonal composition of the disease over time.
Step 4
Follow-up assessments
Regular assessments are scheduled at weeks 2, 4, 12, 24, 48, 72, and 96, and then annually until the study concludes or disease progression occurs.
These assessments focus on monitoring the size of the TP53 mutated subclone compared to the baseline.
Step 5
End of study
The study is estimated to conclude by July 31, 2027. Participants will continue to be monitored until this date or until disease progression is observed.

Who can join the trial?

7 criteria

Must be **18 years or older**.
Must have a **documented diagnosis** of Chronic Lymphocytic Leukemia (CLL) according to specific guidelines from 2008.
Must not have received any previous treatment for CLL, except for **steroid treatment** used to manage autoimmune issues.
Must have a **negative test** for certain hepatitis viruses:
- Negative for **HBsAg** (a marker for hepatitis B infection) and **HBcAb** (another marker for hepatitis B), or if positive for HBcAb, must be negative for **HBV DNA** (a test for active hepatitis B virus) using a specific method called **quantitative PCR**.
- Negative for **HCV antibody** (a marker for hepatitis C infection), or if positive, must be negative for **HCV RNA** (a test for active hepatitis C virus).
- Must have **progressive disease** that requires treatment according to the 2008 guidelines for CLL.
- For a specific group in the study (Cohort 2), there must be evidence of a small group of cells (less than 20%) with a **TP53 deletion** detected by a method called **FISH** (a test to look for specific genetic changes).

Who cannot join the trial?

5 criteria

Patients who do not have **Chronic Lymphocytic Leukemia (CLL)**.
Patients without **TP53 mutations**. These are specific changes in a gene that can affect how cells grow.
Patients who are not in the age range specified for the study.
Patients who are not experiencing progression of their CLL. This means their disease is not getting worse.
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
Azienda Ospedaliero Universitaria Di Sassari
Sassari, Italy
Verified
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Novara, Italy
Verified
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Varese, Italy

Trial locations

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Investigated drugs

Ibrutinib is a medication used in this clinical trial to treat patients with chronic lymphocytic leukemia (CLL) who have specific genetic changes known as TP53 mutations. It works by blocking a protein that helps cancer cells grow and survive, which may slow down or stop the progression of the disease.

Ibrutinib

What is already known about the treatment

Ibrutinib – Ibrutinib is administered orally in the form of a capsule. It is currently well-established in medical literature as a treatment for certain types of blood cancers, including Chronic Lymphocytic Leukemia (CLL). The main therapeutic indication for ibrutinib is the treatment of CLL, particularly in patients with specific genetic mutations like TP53 aberrations. At the molecular level, ibrutinib works by inhibiting a protein called Bruton's tyrosine kinase (BTK), which plays a crucial role in the survival and proliferation of cancer cells. It is classified pharmacologically as a targeted therapy, specifically a BTK inhibitor.

Investigated diseases

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