Study of Zanubrutinib and Rituximab Compared to Bendamustine and Rituximab for Patients with Untreated Mantle Cell Lymphoma Ineligible for Stem Cell Transplant

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What is this study about?

This clinical trial is focused on studying a type of cancer called Mantle Cell Lymphoma, which is a rare form of non-Hodgkin’s lymphoma. The study is comparing two different treatment combinations for patients who have not received any prior treatment for this condition and are not eligible for a stem cell transplant. The first treatment combination includes Zanubrutinib (also known by its code name BGB-3111) and Rituximab. The second treatment combination includes Bendamustine and Rituximab. These medications are given to help manage the disease and improve patient outcomes.

The purpose of the study is to compare the effectiveness of these two treatment combinations. Patients participating in the study will receive one of the two treatment combinations. The study will monitor the patients over a period to see how well the treatments work in controlling the disease. The treatments are administered through infusions, which means they are given directly into the bloodstream through a vein. The study will also look at how long the treatments can keep the disease from getting worse and how they affect the patients’ overall health and quality of life.

Throughout the study, patients will be regularly assessed by healthcare professionals to track their progress and any side effects they may experience. The study aims to provide valuable information on which treatment combination is more effective for patients with Mantle Cell Lymphoma who cannot undergo a stem cell transplant. This information could help guide future treatment decisions for this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the patient meets the study criteria.

2 randomization

Patients are randomly assigned to one of two treatment groups. One group receives zanubrutinib plus rituximab, and the other group receives bendamustine plus rituximab.

3 treatment administration

For the group receiving zanubrutinib and rituximab:

1. Zanubrutinib is taken orally in capsule form. The dosage and frequency are determined by the study protocol.

2. Rituximab is administered intravenously as a solution for infusion. The dosage and schedule are specified in the study protocol.

For the group receiving bendamustine and rituximab:

1. Bendamustine is administered intravenously as a solution for infusion. The dosage and schedule are outlined in the study protocol.

2. Rituximab is also administered intravenously as a solution for infusion, with dosage and schedule specified in the study protocol.

4 monitoring and follow-up

Throughout the study, regular monitoring is conducted to assess the patient’s response to treatment. This includes physical exams, laboratory tests, and imaging studies as needed.

Patient-reported outcomes are collected using specific questionnaires to evaluate quality of life and other health-related factors.

5 completion of treatment

Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment. This includes reviewing all collected data and determining the progression-free survival and other outcomes as defined by the study.

Who Can Join the Study?

Must be at least 70 years old, or between 60 and 69 years old with other health issues that prevent a specific type of stem cell treatment. These health issues include:
- A heart function measurement (called cardiac ejection fraction) of 45% or less
- A lung function measurement (called diffusing capacity for carbon monoxide) of 60% or less
- A kidney function measurement (called creatinine clearance) between 30 and 70 mL/min
- A performance status score of 2, indicating a higher risk of side effects from treatment
- A total score greater than 6 on a health rating scale
Men must agree to use certain birth control methods during the study and for a period after the study, depending on the medication used.
Must be able to provide written consent and understand the study requirements.
Must have a kidney function measurement (creatinine clearance) of at least 30 mL/min.
Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL) based on specific medical criteria.
Must not have received any previous treatments for MCL.
Must have a measurable disease, meaning a tumor that can be measured by size.
Must have tissue samples available to confirm the MCL diagnosis or be willing to undergo a new biopsy.
Must have a performance status score of 0, 1, or 2, indicating the ability to perform daily activities.
Must have a life expectancy of at least 3 months.
Must have adequate organ function, including:
- A certain level of white blood cells (called absolute neutrophil count)
- A certain level of platelets, which help with blood clotting
- Liver function tests within a specific range
- A specific level of bilirubin, a substance made by the liver
Women who can become pregnant must use highly effective birth control methods during the study and for a period after the study, depending on the medication used.

Who Cannot Join the Study?

Patients with other types of cancer besides Mantle Cell Lymphoma cannot participate. Mantle Cell Lymphoma is a specific type of cancer that affects the lymph nodes.
Patients who are not within the specified age range for the study cannot participate. The study is designed for certain age groups only.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent situation, are not eligible.
Patients who have any medical condition or are taking any medication that might interfere with the study results cannot participate.
Patients who are pregnant or breastfeeding are not eligible to participate in the study.
Patients who have participated in another clinical trial recently may not be eligible, as it could affect the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal
Medical University Of Vienna	Vienna	Austria
Centre Hospitalier Universitaire De Lille	Lille	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Institutul Regional De Oncologie Iasi	Iasi	Romania
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego	Walbrzych	Poland
Centre Hospitalier Le Mans	Le Mans	France
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
University Hospital Limerick	Limerick	Ireland
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Hdig Hmceerzv	Hague	The Netherlands
Iahyutsf Pueiaivoxsjgbmt Ckdhbk Cvgcrk	Marseille	France
Hjyubsbt Vptp dapmznqy	Barcelona	Spain
Vzvlea dhn Rkeod Uvnrowomxq Hcaaldht	Sevilla	Spain
Uxawnwlqxz Hhwuuore Cabhnve	Cologne	Germany
Auor Gcmqpj Oblhyvez Mogsktnpumehe Nsdyyxzu	Milan	Italy
Ekbqmxd Uflrlbehheov Mhndwsv Cdzqfsa Rfvkaomct (ucmskzf Mxh	Rotterdam	The Netherlands
Hbukhbzq Uxqajtahxzddn Futaljyfi Jotrene Dsvm	Madrid	Spain
Imafs Oasudbag Praujelnquu Sad Mikswwk	Genoa	Italy
Awstwrs Oqbdzvtaxtw Urkoeahawfhny Ctxmjnowoemz Dosuo Scwpzh E Dzulv Swrcbgq Du Tkfrab	Turin	Italy
Uvvrtowndagmkyyuwlary Hqmdotswir Alq	Heidelberg	Germany
Admlbcz Ojzgvfhoflckzirafqkjxyvpe Mwtdoxzn Dswdu Cpqxso	Novara	Italy
Kkqujbxd dja Ujnehwlkqstp Mhzanzrx Atj	Munich	Germany
Axsydst Uqhtr Syyqyolqa Lgehmc Dm Bruxttl	Bologna	Italy
Uzlnzkwpdcqfaq Csfdqtd Ksxdxvzxu	Gdansk	Poland
Uqitamqtmi Oa Agvcdvl	Edegem	Belgium
Unaeddoiqr Dyioa Slywa Dz Rupo Lj Slnsllrr	Rome	Italy
Oeebcqhombncas Lcty Ggcq	Linz	Austria
Chzjbn hvoytltqupy ufjfbaryvvlop db Ldkze	Liege	Belgium
Uktynmfgvqpy Mxoeuti Cuqlcvu Gywmjnwxh	Groningen	The Netherlands
Cfgnwl Hkygmvhysjp Llxl Sxb	Pierre Benite	France
Vuggb Utvaqaijsqkp Bdhdirn	Jette	Belgium
Ijloqfwl Cwpmuj Dyhstyoqlhvwzouhu	L'hospitalet De Llobregat	Spain
Fvdawbvkd Pgeq Lu Iackkiygwnamu Bhkjjoysm Dyo Hesvpeem Uvxlxmyfeawda Lw Pef	Madrid	Spain
Cnzagpn Oqominjmo Zbzzx Lmorigzenr Irl Soa Jppp Z Dkqbc	Lublin	Poland
Wsdzuqwfepv Wagrmlbdhrjjkwrbgqmi Ctftljy Ogmtqhoyc I Trrmvhmrruuzk Ih Mpzyofbzdor W Lhyjx	Lodz	Poland
Apyfumlc Zczmryiwjc Gonmyvbcl	Kortrijk	Belgium
Sfvbrrgr Pyifagpny Sfq z oxcp	Gdynia	Poland
Uadaqaqaglc Smucgqxl	Salzburg	Austria
Amnkici Owrriekguda Ualliavqnthgu Phoeyc	Pisa	Italy
Asmzlkiy Dl Rvctsj Zpijxefrhg Brjh	Goes	The Netherlands
Cycsuv Hvqxcpjlzfa Iajtrqcxggxzc Dy Cxvdkvaqnxf	Quimper	France
Aibryws Omgccaiiicu Ohptfkvq Rzcnfyk Vajpv Stvoe Cdkbmkhy	Palermo	Italy
Cfspry Hnlznizqgzn Uvwevhvfzzcvf Dk Dvqbb	Dijon	France
Alzwdnt Ozzjzhheddo Ummzgjntoevhr Synfmg	Siena	Italy
Utzsquetfn Hdsnzutj Gyqqtl	Galway	Ireland
Akohgbp Oovapmzzxkx Necarspbd Sz Aqqtshu E Bthftc E C Alojfl Ajiuqdhexjl	Alexandria	Italy
Atyoipi Upx Ilqnl Do Rjzhlb Epksuq	Reggio Emilia	Italy
Cehtfb Rmhgjfly Cdzokuan Dj Vohqtc Sqduub	Verona	Italy
Chqiur Hwaahaeuktj Urjmncrkgecnv Dr Pqqdayzt	Poitiers	France
Clmd Ukfhacifzu Hzitumxz	Cork	Ireland
Iftohspl Hipoavediem I Tmramwktbgqxpno	Warsaw	Poland
Padzwnqciqjztxrgmx	Wuppertal	Germany
Ucnddudqow Htoiglde Wzpyzicsf	Waterford	Ireland
Acmhpd Scnfgprvxn Znvhcmhqpu	Dordrecht	The Netherlands
Mh Algdjvag Coolxn Cnrojf	Madrid	Spain
Pwdqjb Srom	Skorzewo	Poland
Azdspnw Uxkci Smmeezanr Lngcze Dcrtq Rcwnyvn	Faenza	Italy
Iwukdhzp facz Kecxjergx Thzsujojxotavbtivhr uuh Iduinxzyjdbd Ukf gjqnn	Ulm	Germany
Cvknef Hxcyjgtobmp Ugymhxdoukfws Dssfro Gayhsyg Srtdkfjdpwdqwromkpnapbxdsh	Namur	Belgium

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.07.2019
Belgium	Not recruiting	01.07.2019
France	Not recruiting	01.07.2019
Germany	Not recruiting	01.07.2019
Ireland	Not recruiting	01.07.2019
Italy	Not recruiting	01.07.2019
Poland	Not recruiting	01.07.2019
Portugal	Not recruiting	01.07.2019
Romania	Not recruiting	01.07.2019
Spain	Not recruiting	01.07.2019
The Netherlands	Not recruiting	01.07.2019

Trial locations

Investigated Drugs:

Zanubrutinib (BGB-3111) is a medication being studied for its effectiveness in treating mantle cell lymphoma, a type of cancer that affects the lymph nodes. It works by blocking a specific protein that helps cancer cells grow and survive. This medication is being tested to see if it can help patients live longer without their disease getting worse.

Rituximab is a medication used to treat certain types of cancer, including mantle cell lymphoma. It works by targeting and attaching to a specific protein found on the surface of cancer cells, helping the body’s immune system to destroy them. In this trial, it is used in combination with other medications to see if it improves treatment outcomes.

Bendamustine is a chemotherapy drug used to treat certain types of cancer, including mantle cell lymphoma. It works by damaging the DNA of cancer cells, which stops them from growing and dividing. In this study, it is combined with rituximab to evaluate its effectiveness in treating patients who have not received prior treatment for their lymphoma.

Investigated Diseases:

Mantle cell lymphoma

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It typically begins in the outer edge of a lymph node called the mantle zone. The disease often progresses to involve other lymph nodes, bone marrow, and sometimes the spleen and gastrointestinal tract. Patients may experience symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of Mantle Cell Lymphoma can vary, with some cases advancing more rapidly than others. It is considered a challenging condition due to its tendency to be diagnosed at an advanced stage.

Trial ID:

2023-509908-15-00

Protocol code:

BGB-3111-306

NCT ID:

NCT04002297

Trial Phase:

Therapeutic use (Phase IV)

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Study of Zanubrutinib and Rituximab Compared to Bendamustine and Rituximab for Patients with Untreated Mantle Cell Lymphoma Ineligible for Stem Cell Transplant

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?