A study comparing BGB-11417 and zanubrutinib with venetoclax and acalabrutinib for patients with previously untreated chronic lymphocytic leukemia

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What is this study about?

This study is being conducted to compare the effectiveness of two different treatment combinations in patients with Chronic Lymphocytic Leukemia, a type of blood cancer, who have not yet received treatment for this condition. The first combination being studied includes BGB-11417 and Zanubrutinib. The second combination, used for comparison, consists of Venetoclax and Acalabrutinib.

The purpose of the study is to determine which of these two treatment combinations is more effective at preventing disease progression, which is when the cancer begins to grow or spread again. Researchers will also look at overall survival, which is the length of time patients live, and the overall response rate, which measures how many patients see a reduction in the size of their cancer. Additionally, the study will examine undetectable minimal residual disease, a term used to describe a state where very few, if any, cancer cells can be found in the blood or bone marrow using advanced testing.

During the study, participants will be assigned to one of the two treatment groups. They will take the assigned medications orally, meaning by mouth. The study will follow the patients over a period of time to monitor how they respond to the treatments and to track any adverse events, which are side effects or other unexpected medical problems that may occur during the course of the study.

1 randomization and treatment assignment

you will be assigned to one of two treatment groups through a process called randomization, which is a method used to ensure that the assignment to a group is based on chance.

2 treatment group a

if assigned to this group, you will take two medications orally: sonrotoclax (BGB-11417) at a dose of 320 mg as a film-coated tablet and zanubrutinib at a dose of 320 mg as a capsule.

3 treatment group b

if assigned to this group, you will take two medications orally: venetoclax at a dose of 400 mg as a film-coated tablet and acalabrutinib at a dose of 200 mg as a film-coated tablet.

Who Can Join the Study?

You must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL), which is a type of cancer that affects the white blood cells.
Your diagnosis must show specific characteristics, such as monoclonal B cells (a group of identical cancer cells) that have certain markers on their surface called CD5, CD19, CD20, and CD23.
Your blood test must show a certain amount of these cancer cells, specifically 5 x 10^9/L or more in your blood.
You must not have a specific genetic change called t(11:14), which is detected through a test called FISH (a method used to look at chromosomes).
You must require treatment for your leukemia because of one or more of the following: worsening anemia (low red blood cell count), thrombocytopenia (low platelet count), an enlarged spleen (the organ on the left side of the abdomen), enlarged lymph nodes (small lumps in the neck, armpits, or groin), or a rapid increase in lymphocytes (a type of white blood cell).
You may be eligible if you experience symptoms like unintentional weight loss, fevers, night sweats, or significant fatigue (extreme tiredness that prevents you from working or doing daily activities).
Your ECOG Performance Status, which is a scale used to measure how well you can perform daily activities, must be 0, 1, or 2.
The cancer must be visible and measurable on a CT scan or MRI (imaging tests that create detailed pictures of the inside of the body).
You must have adequate marrow function, meaning your bone marrow is producing enough neutrophils (cells that fight infection), platelets (cells that help blood clot), and hemoglobin (a protein in red blood cells that carries oxygen).
You must have adequate liver function, measured by levels of certain enzymes and substances in your blood like AST, ALT, and bilirubin.
You must have adequate renal function, meaning your kidneys are filtering your blood effectively, as measured by creatinine clearance.
You must have a life expectancy of more than 6 months.
You must be an adult, aged 18 years or older, and able to provide written informed consent (a signed document showing you understand and agree to participate).
Women who are able to have children must agree to use highly effective birth control and not donate eggs during the study and for a specific period after the last dose of medication. They must also have negative pregnancy tests before starting.
Men who are not sterile (meaning they are capable of fathering a child) must agree to use highly effective birth control and not donate sperm during the study and for a specific period after the last dose of medication.

Who Cannot Join the Study?

You have previously received systemic treatment (medicine that travels through the whole body) for Chronic Lymphocytic Leukemia (CLL), though small amounts of specific antibody medicine for certain blood issues may be allowed if taken at least 6 months ago.
You have an active fungal, bacterial, or viral infection that requires medicine to treat the whole body.
You have a known hypersensitivity (an allergic reaction) to specific study drugs, their ingredients, or certain medicines used to manage uric acid levels.
You have a history of severe bleeding disorders, such as hemophilia or von Willebrand disease, or have experienced sudden bleeding that required a blood transfusion or other medical help.
You are pregnant or currently breastfeeding.
You have received a live vaccine (a vaccine that uses a weakened form of a germ) within 28 days before starting the study.
You have medical conditions, laboratory abnormalities (unusual results from blood or urine tests), or substance abuse issues that would make the treatment unsafe or prevent you from following the study rules.
You have tested positive for HIV or have an active Hepatitis B or Hepatitis C infection.
You are currently taking warfarin or other similar medicines that thin the blood.
You are taking or have recently taken medicines that affect how the body processes drugs through a specific liver enzyme called CYP3A4.
You have eaten grapefruit, Seville oranges, or star fruit within 3 days before the first dose of the study medicine.
You have prolymphocytic leukemia or signs of Richter’s transformation (a change where the leukemia becomes a more aggressive type of cancer).
You are unable to swallow pills or have gastrointestinal (GI) issues, such as problems with how the body absorbs food, recent stomach or bowel surgery, or a blockage in the intestines.
You are currently taking systemic corticosteroids (strong anti-inflammatory medicines), unless you are taking them to replace hormones your body cannot make on its own.
You have had major surgery within 4 weeks before taking the first dose of the study medicine.
The cancer is known to have spread to the Central Nervous System (CNS), which includes the brain and spinal cord.
You have a history of progressive multifocal leukoencephalopathy (a rare brain infection).
You have severe pulmonary disease (lung disease) that requires you to use extra oxygen or a breathing machine.
You have significant cardiovascular disease (heart problems), such as a recent heart attack, unstable chest pain, severe congestive heart failure, irregular heart rhythms, certain electrical issues in the heart, or very high blood pressure.
You have uncontrolled autoimmune hemolytic anemia (where the immune system destroys red blood cells) or immune thrombocytopenia (where the immune system destroys platelets).
You have a history of other malignancies (cancers), unless they were specific types like certain skin cancers or early-stage prostate cancer that have been treated and are no longer active.
You have used investigational agents (experimental medicines being tested in other studies) within the last 4 weeks.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Lille	Lille	France
Pomeranian Medical University	Szczecin	Poland
Oncopole Claudius Regaud	Toulouse	France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Haga Hospital	Hague	The Netherlands
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Institut Fuer Versorgungsforschung In Der Onkologie GbR	Koblenz	Germany
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza	Brzozow	Poland
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Barmherzige Brueder gemeinnuetzige Traeger GmbH	Straubing	Germany
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie	Munster	Germany
Flevoziekenhuis Stichting	Almere	The Netherlands
Azienda Ospedaliera di Padova	Padua	Italy
Fakultni Nemocnice Plzen	Plzen	Czechia
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Spitalul Clinic Coltea	Bucharest	Romania
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Centre Hospitalier Le Mans	Le Mans	France
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Karolinska University Hospital	Solna	Sweden
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Pratia S.A.	Skorzewo	Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU	Deggendorf	Germany
University Hospital Olomouc	Olomouc	Czechia
Klinikum Osnabrück GmbH	Osnabrück	Germany
University Hospital Ostrava	Ostrava	Czechia
Centrum für Hämatologie und Onkologie Bethanien	Frankfurt	Germany
Fundeni Clinical Institute	Bucharest	Romania
Clbchz Ljyc Bfwkvw	Lyon	France
Akjabim Uadyz Sgbbrjlsa Lxdhah Dy Bkxipsj	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	31.03.2026
France	Recruiting	31.03.2026
Germany	Recruiting	31.03.2026
Italy	Recruiting	31.03.2026
Poland	Recruiting	31.03.2026
Romania	Recruiting	31.03.2026
Spain	Recruiting	31.03.2026
Sweden	Not yet recruiting	31.03.2026
The Netherlands	Recruiting	31.03.2026

Trial locations

Investigated drugs:

BGB-11417 is an experimental medication being tested for its ability to treat certain types of leukemia by targeting specific pathways in cancer cells.

Zanubrutinib is a medication used to treat certain blood cancers by blocking signals that help cancer cells grow and survive.

Venetoclax is a medication that works by helping to trigger the natural death of cancer cells in patients with certain types of leukemia.

Acalabrutinib is a medication that targets and blocks specific proteins in cancer cells to prevent them from multiplying.

Chronic Lymphocytic Leukemia – This is a type of cancer that begins in the white blood cells, specifically the lymphocytes. These abnormal cells build up in the body and do not function properly. The condition typically develops slowly over time. As it progresses, the excess cells can accumulate in the blood, bone marrow, and lymph nodes.

Trial ID:

2025-524366-21-00

Protocol code:

BGB-11417-304

NCT ID:

NCT07277231

Trial Phase:

Therapeutic confirmatory (Phase III)

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A study comparing BGB-11417 and zanubrutinib with venetoclax and acalabrutinib for patients with previously untreated chronic lymphocytic leukemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?