Study Comparing Zanubrutinib with Bendamustine and Rituximab for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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What is this study about?

This clinical trial is focused on studying the effectiveness of different treatments for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have not received treatment before. The study will compare a new medication called Zanubrutinib (also known by its code name BGB-3111) with a combination of two other treatments: Bendamustine and Rituximab. Additionally, the study will involve the use of Venetoclax, which is available in two forms: 50 mg and 100 mg film-coated tablets. The purpose of the study is to determine which treatment is more effective in managing these diseases.

Participants in the study will be randomly assigned to receive either Zanubrutinib or the combination of Bendamustine and Rituximab. Some participants may also receive Venetoclax. The study will monitor the participants over a period to see how well the treatments work in controlling the disease. The treatments will be given in specific doses and schedules, and participants will be closely observed by medical professionals throughout the study. The study will also include a group of participants who will receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The study aims to provide valuable information on the progression-free survival of patients, which means the length of time during and after the treatment that the patient lives with the disease without it getting worse. This information will help in understanding the potential benefits and risks of the treatments being studied. Participants will undergo regular check-ups and tests to monitor their health and the effectiveness of the treatment. The study is expected to continue until 2026, providing insights that could improve future treatment options for CLL and SLL.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, physical examination, and necessary laboratory tests to ensure adequate organ and bone marrow function.

2 randomization

Participants are randomly assigned to different treatment groups. This process ensures that each participant has an equal chance of receiving any of the study treatments.

3 treatment administration

Participants receive treatment based on their assigned group. The treatments include venetoclax (Venclyxto) in 50 mg and 100 mg film-coated tablets for oral use, zanubrutinib in capsule form for oral use, and rituximab (MabThera) as a solution for infusion administered intravenously.

The specific dosage and frequency of each medication depend on the treatment group and the participant’s response to the treatment.

4 monitoring and follow-up

Regular monitoring is conducted to assess the participant’s response to treatment and to identify any side effects. This includes physical examinations, laboratory tests, and imaging studies such as CT or MRI scans.

Participants are required to attend scheduled follow-up visits to ensure the treatment’s effectiveness and to monitor for any adverse effects.

5 completion of treatment

Upon completion of the treatment phase, participants undergo a final assessment to evaluate the overall response to the treatment. This includes a comprehensive review of all collected data and any remaining health concerns.

6 long-term follow-up

Participants may be asked to participate in long-term follow-up to monitor their health status and any long-term effects of the treatment. This phase is crucial for understanding the treatment’s long-term efficacy and safety.

Who Can Join the Study?

Patients must have untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
Patients must be unsuitable for treatment with FCR (a type of chemotherapy) if they are 65 years or older, or if they are 18-64 years old and have one or more of the following:
- A Cumulative Illness Rating Scale (CIRS) score greater than 6. This is a way to measure overall health problems.
- Creatinine clearance less than 70 mL/min, which is a measure of kidney function.
- A history of serious infections or multiple infections in the past 2 years.
Male patients must either have had a vasectomy or agree to use barrier contraception (like condoms) during the study and for at least 90 days after the last dose of the study drug.
Patients must be able to provide written informed consent, meaning they understand and agree to the study requirements.
Patients must have FISH test results from a central laboratory confirming the presence or absence of del17p. This is a specific genetic test related to CLL/SLL.
Patients must have a confirmed diagnosis of CD20-positive CLL or SLL that meets specific criteria.
Patients must have measurable disease by CT/MRI, meaning at least one lymph node is larger than 1.5 cm in its longest diameter.
Patients must have CLL/SLL that requires treatment.
Patients must have an ECOG performance status of 0, 1, or 2, which is a scale to assess how well they can perform daily activities.
Patients must have a life expectancy of at least 6 months.
Patients must have adequate bone marrow function, which is important for producing blood cells.
Patients must have adequate organ function, meaning their organs are working well enough to participate in the study.
Female patients of childbearing potential must use highly effective contraception before starting the study drug, during the study, and for a specified time after the last dose, depending on the drug.

Who Cannot Join the Study?

Patients with untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma cannot participate. These are types of blood cancers.
Patients who are part of a vulnerable population are excluded. This means people who might be at higher risk of harm or who might not be able to give informed consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier Victor Dupouy	Argenteuil	France
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich	Chorzow	Poland
Region Oerebro Laen	Orebro	Sweden
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza	Brzozow	Poland
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Consorci Mar Parc De Salut De Barcelona	Barcelona	Spain
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen	Boras	Sweden
Region Norrbotten	Lulea	Sweden
Hospital Quironsalud Zaragoza	Zaragoza	Spain
Universita’ Degli Studi Di Modena E Reggio Emilia	Modena	Italy
Centre Henri Becquerel	Rouen	France
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Region Skane Skanes Universitetssjukhus	Lund	Sweden
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
Pratia S.A.	Skorzewo	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Centre Hospitalier Universitaire De Rennes	Rennes	France
University Hospital Olomouc	Olomouc	Czechia
Wojewodzki Szpital Specjalistyczny W Legnicy	Legnica	Poland
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Vrije Universiteit Brussel	Jette	Belgium
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Clinique Saint-Pierre Ottignies (CSPO)	Ottignies	Belgium
Uniklinikum Salzburg	Salzburg	Austria
Cqztld Hgzijfjmobt Ullqqnyczxrqg Roxjf	Reims	France
Ofrpaxynpfpjar Lwrc Geic	Linz	Austria
Hndpznwt Ubjxrfiatlgpt De Le Pchvvegl	Madrid	Spain
Iaacsaci Cnetsd Dedruebemeolacnas	L'hospitalet De Llobregat	Spain
Wovygwyqphf Wpbobdbwwyvtlyxyaoem Csrtrjc Ogbaqhotm I Tlixdtunstlqw Ic Mcqwufxyfou W Lfioz	Lodz	Poland
Cwwdrx Hozqujbiycn Eg Urdcubiotzlif De Lgrlonk	Limoges	France
Urubjss Uunueamrwb Hhbppisd	Uppsala	Sweden
Caiovs Hvgiuoukumq Rchfxoli Uvlsvubrqlbdm Dn Ttsyx	Tours	France
Atvmfui Oiqwbyevgpu Upjldkzhmkhih Cnoogjscqngc Ddujb Szorsu E Dqgwt Sskwrzh Dd Tltsyb	Turin	Italy
Cipf Dv Nbhzx	Vandoeuvre Les Nancy	France
Nbhouffu Imloneyo Oxcsjkzai Ilv Mqhmn Szzyhocfqsvztrxbrwhgwvehypbm Iglwhjyj Bppgjicb	Cracow	Poland
Hovnbkvs Uzoxfrywuwbvv Hldrylla Tlseo y Pdtpiy Icjhpsdz Cimqwv dyvoityfajwgauvgb (vbow	Badalona	Spain
Iublkofe Pteftpghejkdatq Cyaypl Ccffsr	Marseille	France

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	19.09.2017
Belgium	Not recruiting	19.09.2017
Czechia	Not recruiting	19.09.2017
France	Not recruiting	19.09.2017
Italy	Not recruiting	19.09.2017
Poland	Not recruiting	19.09.2017
Spain	Not recruiting	19.09.2017
Sweden	Not recruiting	19.09.2017

Trial locations

BGB-3111 is a medication being studied for its effectiveness in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is being compared to other treatments to see how well it works in stopping the progression of these diseases.

Bendamustine is a chemotherapy drug used to treat certain types of cancer, including CLL and SLL. It works by slowing or stopping the growth of cancer cells.

Rituximab is a medication that targets specific cells in the immune system. It is used in combination with other drugs to treat CLL and SLL by helping the immune system destroy cancer cells.

Chronic Lymphocytic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the production of too many abnormal white blood cells called lymphocytes. These abnormal cells accumulate over time, crowding out healthy blood cells and impairing the immune system. The disease often progresses slowly, and many people may not experience symptoms for years. As it advances, symptoms such as fatigue, swollen lymph nodes, and frequent infections may occur. The progression can vary greatly among individuals, with some experiencing a more aggressive form of the disease.

Small Lymphocytic Lymphoma – This is a type of non-Hodgkin lymphoma that primarily affects the lymph nodes, but it is closely related to chronic lymphocytic leukemia. It involves the overproduction of small, mature lymphocytes that accumulate in the lymph nodes, spleen, and sometimes the bone marrow. The disease typically progresses slowly, and symptoms may include swollen lymph nodes, fatigue, and night sweats. As it advances, it can lead to complications such as infections due to a weakened immune system. The progression rate can vary, with some individuals experiencing a more indolent course while others may have a more aggressive progression.

Trial ID:

2023-509976-40-00

Protocol code:

BGB-3111-304

NCT ID:

NCT03336333

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Zanubrutinib with Bendamustine and Rituximab for Patients with Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?