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

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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), 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.

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.

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.

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.

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.

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 Study?

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.
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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Hospital Santa Maria Della Misericordia	Perugia	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Agdkgwl Oysijsctfwc Udxtpqjkkfonh Cxffavjidhvs Dxtqe Sfreje E Dvkxu Ssgwvbu Di Tjyrib	Turin	Italy
Apkxaqh Owhembewgdh Nvjcsolkj Si Aqdxiop E Bcggmz E C Axblke Ayquulswqbj	Alexandria	Italy
Alfbbow Oaiqhnqubxw Plie Gncvggcu Xbdkn	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	31.01.2021

Trial locations

Investigated drugs:

Venetoclax

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.

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 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.

Trial ID:

2024-514687-33-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?