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Study on Zanubrutinib and Obinutuzumab for Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Patients

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 is focused on studying two diseases: Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). These are types of blood cancers that affect the white blood cells. The study will use a combination of two treatments: zanubrutinib and obinutuzumab. Zanubrutinib, also known by its code name BGB-3111, is a medication taken orally in capsule form. Obinutuzumab is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how effective and safe the combination of zanubrutinib and obinutuzumab is for patients who have not received treatment for their CLL or SLL before. The study will compare two different schedules for administering obinutuzumab to see which is more effective. Participants will receive these treatments over a period of time, and their health will be monitored to see how well the cancer responds to the treatment and to check for any side effects.

Throughout the study, researchers will look at various outcomes, such as the rate of complete remission, which means the cancer is no longer detectable, and how long patients live without the disease getting worse. They will also assess the overall safety of the treatments and any potential side effects. This study aims to provide valuable information on the best way to treat these types of blood cancers with the combination of zanubrutinib and obinutuzumab.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A pregnancy test is required for women of childbearing potential to ensure safety during the trial.
Step 2
Treatment initiation
The treatment involves two medications: obinutuzumab and zanubrutinib.
Obinutuzumab is administered as an intravenous infusion. The schedule for this medication varies, starting either at cycle 2 or after 12 months.
Zanubrutinib is taken orally in capsule form. The dosage and frequency are determined by the study protocol.
Step 3
Treatment cycles
The study consists of multiple treatment cycles. Each cycle includes the administration of the medications as per the assigned schedule.
Regular monitoring is conducted to assess the response to treatment and to manage any side effects.
Step 4
Monitoring and assessments
Throughout the trial, regular visits are scheduled to monitor health status and treatment effectiveness.
Assessments include blood tests, imaging studies, and evaluations of any symptoms or side effects.
Step 5
Completion of treatment
Upon completion of the treatment cycles, a final assessment is conducted to evaluate the overall response to the therapy.
The study aims to determine the complete response rate with undetectable minimal residual disease.
Step 6
Follow-up
After the treatment phase, follow-up visits are scheduled to monitor long-term health outcomes and any delayed side effects.
The follow-up period helps in understanding the overall survival and progression-free survival rates.

Who can join the trial?

13 criteria

Patients must have **Chronic Lymphocytic Leukemia (CLL)** or **Small Lymphocytic Lymphoma (SLL)** and have not received treatment for it before.
Patients must be adults, meaning they are **18 years or older**.
Patients need to understand and willingly sign a document called an **informed consent form**, which explains the study and their role in it.
Patients must have a confirmed diagnosis of CLL or SLL, meeting at least one of the following conditions:
- Worsening **anemia** (low red blood cells) or **thrombocytopenia** (low platelets).
- Large or worsening **spleen** (an organ in the body) or symptoms related to it.
- Large or worsening **lymph nodes** (small glands in the body) or symptoms related to them.
- Increasing number of **lymphocytes** (a type of white blood cell) by 50% over 2 months or doubling in less than 6 months.
- Symptoms like losing 10% of body weight unintentionally in 6 months, severe tiredness, fevers over 38°C for 2 weeks, or night sweats for more than a month.
- **Autoimmune complications** like anemia or thrombocytopenia that don't respond well to treatment.
- Symptoms or problems in areas outside the lymph nodes, like skin or lungs.
- Patients must have a **performance status** score of 2 or less, which means they can do most daily activities.
- Female patients who can have children must use **highly effective birth control** methods before starting the study, during the study, and for a certain time after the study ends. Male patients must agree to use **barrier contraception** (like condoms) or have had a **vasectomy** (a procedure to prevent having children).
- Female patients who can have children must have a **negative pregnancy test** before starting the study.

Who cannot join the trial?

2 criteria

Patients who have already received treatment for Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) cannot participate. This means if you have been treated for these conditions before, you are not eligible.
Patients who are part of a vulnerable population are not eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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

El Hospital Universitario De Gran Canaria Dr. Negrin
Verified
Las Palmas De Gran Canaria, Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hestia Duran I Reynals
Verified
L'hospitalet De Llobregat, Spain

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Investigated drugs

Zanubrutinib
is a medication used in this trial to treat patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). It works by blocking a specific protein in the body that helps cancer cells grow and survive. By inhibiting this protein, zanubrutinib can help slow down or stop the progression of the disease.
Obinutuzumab
is another medication used in combination with zanubrutinib in this trial. It is a type of antibody therapy that targets and attaches to a specific protein found on the surface of cancer cells. This helps the immune system recognize and destroy these cancer cells. The trial is testing different schedules for administering obinutuzumab to see which is more effective in achieving complete remission in patients.

What is already known about the treatment

Zanubrutinib
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). It is a type of drug known as a Bruton's tyrosine kinase (BTK) inhibitor, which works by blocking a specific protein that helps cancer cells grow and survive. Zanubrutinib is classified as a targeted therapy, aiming to interfere with cancer cell growth at the molecular level.
Obinutuzumab
This medication is given through intravenous infusion and is being evaluated in combination with zanubrutinib for the treatment of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). It is a monoclonal antibody that targets the CD20 protein on the surface of certain cancer cells, leading to their destruction. Obinutuzumab is classified as an immunotherapy, which helps the immune system fight cancer more effectively.

Investigated diseases

Chronic Lymphocytic Leukemia (CLL)
This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal lymphocytes, a type of white blood cell. It progresses slowly and may not cause symptoms for years. Over time, these abnormal cells can crowd out healthy blood cells, leading to issues like anemia, infections, and bleeding problems. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. CLL is more common in older adults and is often discovered during routine blood tests before symptoms appear.
Small Lymphocytic Lymphoma (SLL)
This is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes, but it is closely related to chronic lymphocytic leukemia. SLL involves the same type of abnormal lymphocytes as CLL, but these cells are mainly found in the lymph nodes rather than the blood and bone marrow. The disease progresses slowly, and symptoms may include swollen lymph nodes, fatigue, and night sweats. As it advances, SLL can affect other organs and tissues, similar to CLL. It is typically diagnosed in older adults and may be found incidentally during examinations for other conditions.