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Study on Lymph Node Changes in Chronic Lymphocytic Leukemia Patients Treated with Venetoclax

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying changes in the lymph nodes of patients with Chronic Lymphocytic Leukemia (CLL) who are treated with a medication called venetoclax. Venetoclax, also known by its code names ABT-199 and GDC-0199, is a chemical substance used to treat CLL. The purpose of the study is to evaluate how the lymph nodes of CLL patients change at both the molecular level and through ultrasound imaging when treated with venetoclax-based regimens.

Participants in the study will receive treatment with venetoclax, which is taken orally. The study will observe and analyze the lymph nodes of these patients over a period of time to understand the effects of the treatment. This includes looking at the cells in the lymph nodes and using ultrasound to see any changes. The study aims to gather information about the characteristics of the lymph nodes and the activity of the CLL cells after 12 months of treatment with venetoclax.

The study will help researchers understand more about how venetoclax affects the lymph nodes in patients with CLL. This information could be valuable for improving treatment strategies for CLL in the future. The study is expected to continue until the end of 2027, with recruitment of participants starting at the end of 2024.

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
Upon joining the study, the treatment begins with the administration of venetoclax. This medication is taken orally.
The initial phase involves a gradual increase in the dosage of venetoclax, known as the ramp-up phase. This phase is designed to help the body adjust to the medication.
Step 2
Ramp-up phase
During the ramp-up phase, the dosage of venetoclax is increased over a period of time. This is done to minimize potential side effects and ensure the body tolerates the medication well.
The specific duration and dosage increments are determined by the study protocol and the healthcare team overseeing the trial.
Step 3
Treatment phase
After completing the ramp-up phase, the patient continues to take venetoclax at a stable dosage as part of the treatment phase.
This phase lasts for a specified period, during which the effects of the medication on the lymph nodes and overall health are monitored.
Step 4
Monitoring and evaluation
Throughout the trial, regular evaluations are conducted to assess changes in the lymph nodes at both the molecular and ultrasound levels.
These evaluations help in understanding the impact of venetoclax on chronic lymphocytic leukemia (CLL) and its effectiveness in modifying the lymph node microenvironment.
Step 5
Completion of treatment
The primary endpoints of the study are assessed 12 months after the completion of the venetoclax ramp-up phase.
These assessments include characterizing the CLL lymphocytes and lymph node-derived cells, as well as defining the ultrasound characteristics of the lymph nodes.

Who can join the trial?

6 criteria

Must have a diagnosis of Chronic Lymphocytic Leukemia (CLL), which is a type of cancer that affects the blood and bone marrow.
Should be a candidate for treatment with venetoclax-based regimens, which are specific treatment plans that include the drug venetoclax.
Must have a basal value of platelets greater than 100x10⁹/l. Platelets are small blood cells that help with clotting.
PT INR and aPTT should be within normal limits. These are blood tests that measure how well your blood clots.
Both male and female participants are eligible.
Participants from vulnerable populations are also eligible.

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Verified sites

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Ospedale San Raffaele S.r.l.
Verified
Milan, Italy

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Investigated drugs

Venetoclax is a medication used in this trial to treat patients with chronic lymphocytic leukemia (CLL). It works by targeting and blocking a specific protein in cancer cells, which helps to kill these cells and reduce the size of lymph nodes. The trial aims to observe how this medication affects the lymph nodes at both the molecular and ultrasound levels.

Venetoclax

What is already known about the treatment

Venetoclax – Venetoclax is administered orally in the form of tablets. It is currently used in the treatment of Chronic Lymphocytic Leukemia (CLL) and is well-documented in medical literature for its effectiveness in this area. The main therapeutic indication for venetoclax is to treat CLL, particularly in patients who have not responded to other treatments. At the molecular level, venetoclax works by inhibiting a protein called BCL-2, which helps cancer cells survive; by blocking this protein, venetoclax promotes the death of these cancer cells. It is classified as a BCL-2 inhibitor in pharmacology.

Investigated diseases

Chronic Lymphocytic Leukemia – Chronic Lymphocytic Leukemia (CLL) 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, leading to a gradual increase in their numbers in the blood and lymphoid tissues. As the disease progresses, it can cause enlargement of lymph nodes, spleen, and liver. Patients may experience symptoms such as fatigue, weight loss, and frequent infections due to the impaired immune system. CLL typically progresses slowly, and its course can vary significantly among individuals.