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Study of Venetoclax, Ibrutinib, and Rituximab for Patients with Untreated Chronic Lymphocytic Leukemia

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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), specifically in patients who have not received any previous treatment. The study involves a combination of medications: Venetoclax, Rituximab, and Ibrutinib. Venetoclax, also known by its code names ABT-199 and GDC-0199, is taken orally and works by helping to kill cancer cells. Rituximab is given later in the treatment process, and Ibrutinib is used to consolidate, or strengthen, the treatment effects.

The purpose of the study is to evaluate how effective this combination of medications is in reducing the amount of cancer cells to a very low level, known as minimal residual disease, in patients with CLL. The study will follow patients through a course of treatment that can last up to 24 months. During this time, the effectiveness of the treatment will be monitored to see if the cancer cells become undetectable.

Participants in the study will receive the medications in a specific sequence, starting with Venetoclax, followed by Rituximab, and then Ibrutinib. The goal is to achieve the best possible response in reducing cancer cells, which will be checked using a method called 6-color cytofluorimetry, a technique that helps to detect very small amounts of cancer cells in the bone marrow. The study aims to see if this combination can help patients achieve a state where the cancer is not detectable, which is a positive outcome for those with CLL.

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
Initiation of treatment
The treatment begins with the administration of venetoclax. This medication is taken orally. The dosage and frequency will be determined by the healthcare provider based on individual patient needs and response to treatment.
Step 2
Addition of rituximab
Rituximab is introduced after the initial phase with venetoclax. The timing of rituximab administration is delayed to optimize treatment outcomes. The healthcare provider will provide specific instructions regarding the schedule and dosage.
Step 3
Consolidation with ibrutinib
Following the administration of rituximab, ibrutinib is added to the treatment regimen. This phase aims to consolidate the treatment effects and increase the likelihood of achieving minimal residual disease. The healthcare provider will guide the patient on the dosage and duration of ibrutinib therapy.
Step 4
Monitoring and evaluation
Throughout the treatment, regular monitoring is conducted to assess the response. This includes evaluating the presence of minimal residual disease using specialized tests. The goal is to achieve undetectable levels of disease, which will be assessed up to three months after completing the combined therapy.
Step 5
Completion of treatment
The treatment concludes after the completion of the combined therapy with venetoclax, rituximab, and ibrutinib. The healthcare provider will conduct a final evaluation to determine the treatment's effectiveness and discuss any further steps if necessary.

Who can join the trial?

8 criteria

You must be between 18 and 64 years old.
You have **Chronic Lymphocytic Leukemia (CLL)** or **Small Lymphocytic Lymphoma (SLL)** that needs treatment. These are types of blood cancer.
You have not received any previous treatment for CLL or SLL.
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Your bone marrow, which is the soft tissue inside your bones that makes blood cells, is working well enough. This means:
- Your **Absolute Neutrophil Count (ANC)**, a type of white blood cell, is at least 1.0 x 10⁹/L.
- Your **Platelet Count (Plt)**, which helps with blood clotting, is at least 25 x 10⁹/L.
- Your **Hemoglobin (Hb)** level, which carries oxygen in your blood, is at least 8.0 g/dl.
- Both men and women can participate.
- You are not part of a vulnerable population, which means you are not in a group that needs special protection in research studies.

Who cannot join the trial?

3 criteria

Patients who have already received treatment for their Chronic Lymphocytic Leukemia cannot participate. This means if you have been treated for this type of blood cancer before, you are not eligible.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements that must be met.
Patients who belong to a vulnerable population are not eligible. This refers to groups of people who might be at a higher risk of harm or exploitation.

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Verified sites

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

Verified
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Verified
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Alexandria, Italy
Responsive
Universita' Degli Studi Di Verona
Verona, Italy

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Investigated drugs

Venetoclax
is a medication used to treat chronic lymphocytic leukemia (CLL). It works by helping to kill cancer cells and is often used in combination with other treatments to improve its effectiveness.
Rituximab
is a type of therapy that targets specific proteins on the surface of cancer cells. In this trial, it is used in a delayed manner to help enhance the treatment's effectiveness against CLL.
Ibrutinib
is a medication that helps to stop the growth and spread of cancer cells. It is used as a consolidation therapy in this trial to help achieve undetectable levels of minimal residual disease in patients with CLL.

Venetoclax

What is already known about the treatment

Venetoclax
Venetoclax is administered orally in tablet form. It is currently used in the treatment of chronic lymphocytic leukemia (CLL), particularly in patients who have not received prior treatment. The medication works by inhibiting a protein called BCL-2, which helps cancer cells survive. By blocking this protein, venetoclax promotes the death of cancer cells. It is classified as a BCL-2 inhibitor.
Rituximab
Rituximab is given through intravenous infusion. It is widely used in the treatment of various types of blood cancers, including chronic lymphocytic leukemia (CLL). Rituximab targets a protein called CD20 found on the surface of certain cancer cells, leading to their destruction. It belongs to a class of drugs known as monoclonal antibodies.
Ibrutinib
Ibrutinib is taken orally in capsule form. It is an established treatment for chronic lymphocytic leukemia (CLL) and works by blocking a protein called Bruton's tyrosine kinase (BTK), which is involved in the growth and survival of cancer cells. By inhibiting this protein, ibrutinib helps to slow down or stop the progression of the disease. It is classified as a BTK inhibitor.

Investigated diseases

Chronic Lymphocytic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the production of an excessive number of abnormal white blood cells. These cells, called lymphocytes, accumulate over time and can interfere with normal blood cell production. The disease often progresses slowly and may not cause symptoms for years. As it advances, it can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. The abnormal cells can also spread to other parts of the body, including the liver and spleen. Chronic lymphocytic leukemia is more common in older adults and is typically diagnosed through blood tests.