Recruiting

Study of venetoclax, obinutuzumab and zanubrutinib combination therapy in young patients with high-risk Chronic Lymphocytic Leukemia and residual disease

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on treating patients with Chronic Lymphocytic Leukemia who have not received previous treatment. The study examines a combination therapy using several medications: venetoclax, obinutuzumab, and zanubrutinib. Chronic Lymphocytic Leukemia is a type of blood cancer that affects white blood cells in bone marrow and blood.

The treatment begins with a combination of venetoclax and obinutuzumab for all participants. After this initial treatment, depending on how well patients respond, they will either continue receiving venetoclax alone or receive a combination of venetoclax with zanubrutinib. The purpose of this study is to evaluate how effective these drug combinations are at eliminating traces of cancer cells from the blood and bone marrow.

During treatment, patients may also receive supportive medications including chlorphenamine maleate, dexamethasone phosphate, paracetamol, allopurinol, lamivudine, and a combination of sulfamethoxazole and trimethoprim to manage potential side effects or prevent complications. The study will monitor patients' response to treatment and track any side effects that may occur.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Treatment begins with a combination of two medications: venetoclax (taken orally) and obinutuzumab (given by infusion)
This initial phase lasts for 9 months
Before starting treatment, you will receive medications to prevent possible complications: allopurinol, paracetamol, chlorphenamine maleate, and dexamethasone
Step 2
Disease evaluation
After 9 months, your doctor will check the level of disease in your blood and bone marrow
Based on these results, you will be assigned to one of two treatment paths
Step 3
Continuation phase
If minimal disease remains: you will continue taking only venetoclax (oral medication)
If higher levels of disease remain: you will receive a combination of venetoclax and zanubrutinib (both taken orally)
Step 4
Follow-up evaluations
Regular disease level checks will occur at months 15, 21, 27, 33, and 36
These checks will involve blood tests and bone marrow examinations
The total duration of the study is 36 months (3 years)

Who can join the trial?

19 criteria

Age between 18 and 65 years
Female patients who can become pregnant must have a negative pregnancy test within 7 days before starting treatment
Both male and female participants must agree to use effective birth control methods or abstain from sexual intercourse during treatment and:
- For 90 days after last dose of zanubrutinib
- For 30 days after last dose of venetoclax
- For 18 months after last dose of obinutuzumab
- Must sign an informed consent document
- Must be willing to follow study requirements
- Must have confirmed CLL (Chronic Lymphocytic Leukemia) diagnosis according to current medical criteria
- Must have good general health status with:
  - Low illness burden score (CIRS less than 6)
  - Adequate kidney function
  - Good physical performance status
  - No previous treatment for CLL
  - Must have specific genetic markers in blood cells (unmutated IGHV, TP53 mutation, or deletion 17p)
  - Must have active disease requiring treatment
  - Must have adequate blood test results:
    
    Acceptable white blood cell counts
    Adequate platelet levels
    Sufficient hemoglobin levels
    Must have normal liver function tests
    Must have normal heart rhythm measurements (QT interval)

Who cannot join the trial?

15 criteria

Previous treatment for Chronic Lymphocytic Leukemia (a type of blood cancer)
Age over 65 years
Active or uncontrolled infections
Pregnant or breastfeeding women
Major surgery within 4 weeks before starting the study
Significant heart problems or uncontrolled heart disease
Severe liver disease
Severe kidney disease
Other active cancers requiring treatment
Known allergies to study medications
Mental conditions that could interfere with following study procedures
Participation in another clinical trial within 30 days
HIV, active hepatitis B, or hepatitis C infection
Uncontrolled autoimmune conditions (conditions where the immune system attacks healthy cells)
History of severe allergic reactions to biological treatments (medications made from living organisms)

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Azienda Ospedaliera Ordine Mauriziano Di Torino
Responsive
Turin, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Responsive
Palermo, Italy
Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Venetoclax
A medication used to treat chronic lymphocytic leukemia (CLL). It works by blocking a protein called BCL-2, which helps cancer cells survive. By blocking this protein, venetoclax helps destroy cancer cells.
Obinutuzumab
A targeted therapy that attaches to a protein called CD20 found on certain blood cells. It helps your immune system identify and destroy cancer cells. This medication is given through an intravenous (IV) infusion.
Zanubrutinib
A medication that belongs to a class of drugs called BTK inhibitors. It works by blocking a protein that helps cancer cells grow and survive. This medication helps stop the growth and spread of cancer cells in patients with chronic lymphocytic leukemia.

What is already known about the treatment

Venetoclax
An oral medication used in the treatment of Chronic Lymphocytic Leukemia (CLL), administered in tablet form. It works by blocking the BCL-2 protein, which helps cancer cells survive, leading to their death. This targeted therapy belongs to the class of BCL-2 inhibitors and has shown significant effectiveness in treating CLL, particularly in patients with high-risk factors.
Obinutuzumab
A monoclonal antibody medication administered through intravenous infusion for treating Chronic Lymphocytic Leukemia (CLL). It works by targeting the CD20 protein on B-cells, helping the immune system identify and destroy cancer cells. This medication belongs to the class of targeted immunotherapies and is often used in combination with other treatments for better effectiveness in CLL patients.
Zanubrutinib
An oral medication taken in capsule form that belongs to the class of Bruton's tyrosine kinase (BTK) inhibitors, used in treating Chronic Lymphocytic Leukemia (CLL). It works by blocking specific signals that B-cell cancer cells need to survive and multiply. This newer generation BTK inhibitor has shown promising results in clinical trials, particularly when used in combination therapy for CLL treatment.

Investigated diseases

Chronic Lymphocytic Leukemia - A slow-growing blood cancer that starts in white blood cells called lymphocytes in the bone marrow. These abnormal cells gradually increase and spread through the blood to lymph nodes and other organs. The disease develops when the bone marrow makes too many abnormal lymphocytes that don't work properly. Over time, these cancerous cells can crowd out normal blood cells, leading to enlarged lymph nodes and a weakened immune system. The condition typically progresses slowly, and some people may not need immediate treatment after diagnosis.